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Ziel unserer Forschung ist die Entwicklung neuer Ansätze und Optionen für Prävention, Diagnose und Therapie. Um unsere Patientinnen und Patienten besser behandeln zu können, setzen wir uns dafür ein, neue Wirkstoffe in die Klinik zu bringen. Einer der letzten Schritte auf diesem Weg ist die klinische Studie. Wenn es ein Wirkstoff schafft, den langen Weg aus der Grundlagenforschung über die klinische Forschung bis hin zu einem Medikament zu meistern – und wenn Ärztinnen und Ärzte dieses neue Medikament dann verschreiben können, spricht man von gelungener Translation.
Über die folgende Aufstellung können Sie sich zu den mehr als 300 klinischen Studien informieren, an denen unsere Wissenschaftlerinnen und Wissenschaftler seit dem Jahr 2021 beteiligt sind.
| Id | Clinical Study Name | Clinical Study Name (ohne Link) | DZL Disease Area | Disease | DZL Participating Sites | Status | NCT Number | EUCT/CTIS Number | DRKS-ID | Study-ID | Study Type | DZL Role | Funding | Brief Summary | URL | Content | Start | Completion |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Id | Clinical Study Name | Clinical Study Name (ohne Link) | DZL Disease Area | Disease | DZL Participating Sites | Status | NCT Number | EUCT/CTIS Number | DRKS-ID | Study-ID | Study Type | DZL Role | Funding | Brief Summary | URL | Content | Start | Completion |
| 50.929 | A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008) | A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008) | LC | SCLC | BREATH | Closed | 2021-005034-42 | 2021-005034-42 | Interventional | DZL recruiting center | Externally - industry | To evaluate change from baseline in visual analog scale using the EQ-5D-5L questionnaire for MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A compared to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab | To evaluate change from baseline in visual analog scale using the EQ-5D-5L questionnaire for MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A compared to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab | 16.08.22 | 31.12.24 | |||
| 50.945 | A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA). | A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA). | PALI | Viral Lung Infection | ARCN, BREATH | Recruiting | NCT05624450 | 2022-003107-15, 2023-507031-38 | NCT05624450, 2022-003107-15, 2023-507031-38 | Interventional | DZL recruiting center | Externally - industry | A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA). To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 28 | A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA). To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 28 | 25.01.23 | 15.04.26 | ||
| 50.952 | A PRAGMATIC ADAPTIVE RANDOMIZED, CONTROLLED PHASE II/III MULTICENTER STUDY OF IFX-1 IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA | A PRAGMATIC ADAPTIVE RANDOMIZED, CONTROLLED PHASE II/III MULTICENTER STUDY OF IFX-1 IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA | PALI | Severe pneumonia in context of Coronavirus Disease-19 (COVID-19) | BREATH | Closed | 2020-001335-28 | 2020-001335-28 | Interventional | DZL recruiting center | Externally - industry | To demonstrate the efficacy of IFX-1 to improve survival outcomes of severe COVID-19 pneumonia (confirmative) | To demonstrate the efficacy of IFX-1 to improve survival outcomes of severe COVID-19 pneumonia (confirmative) | 04.02.21 | 01.06.22 | |||
| 50.973 | A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial) | A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial) | LC | SCLC | TLRC | Active / not recruiting | NCT05153239 | 2021-004471-13 | NCT05153239, 2021-004471-13 | Interventional | DZL recruiting center | Externally - industry | Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line. | Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line. | 22.07.22 | 30.04.26 | ||
| 51.051 | DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer | DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer | LC | SCLC | TLRC | Recruiting | NCT05990738 | 2023-506007-26-00 | NCT05990738, 2023-506007-26-00 | Interventional | DZL recruiting center | Externally - industry | This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment. The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment. | This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment. The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment. | 14.02.24 | 30.04.26 | ||
| 51.052 | DeLLphi-304 | DeLLphi-304 | LC | SCLC | BIH / Charité - Associated Partner | Closed | NCT05740566 | 2022-502669-14 | NCT05740566, 2022-502669-14 | Interventional | DZL recruiting center | Externally - industry | "A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-304)" | "A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-304)" | 18.04.24 | 31.12.27 | ||
| 51.113 | M23-385 | M23-385 | LC | SCLC | CPC-M | Recruiting | NCT05599984 | 2023-504598-18 | NCT05599984, 2023-504598-18 | Interventional | DZL recruiting center | Externally - industry | A Phase 1 first-in-human study evaluating safety, pharmacokinetics and efficacy of ABBV-706 as monotherapy and in combination with budigalimab (ABBV-181), carboplatin, or cisplatin in adult subjects with advanced solid tumors. | A Phase 1 first-in-human study evaluating safety, pharmacokinetics and efficacy of ABBV-706 as monotherapy and in combination with budigalimab (ABBV-181), carboplatin, or cisplatin in adult subjects with advanced solid tumors. | 05.12.22 | 17.05.27 | ||
| 51.134 | ON-TRK | ON-TRK | LC | SCLC/NSCLC | CPC-M | Recruiting | NCT04142437 | NCT04142437 | Interventional | DZL recruiting center | Externally - industry | ON-TRK: PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib | ON-TRK: PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib | 03.04.20 | 31.03.30 | |||
| 51.157 | RESCUE 3 | RESCUE 3 | COPD | Weaning Failure | BIH / Charité - Associated Partner | Closed | NCT03783884 | NCT03783884 | Interventional | DZL recruiting center | Externally - industry | randomisierte, kontrollierte, unverblindete, multizentrische, adaptive klinische Prüfung zur Untersuchung der sicheren und wirksamen Leistung des Lungpacer-Therapiesystems zur Zwerchfellstimulation (Diaphragm Pacing Therapy System, DPTS) bei Patienten, bei denen eine Beatmungsentwöhnung fehlgeschlagen ist | randomisierte, kontrollierte, unverblindete, multizentrische, adaptive klinische Prüfung zur Untersuchung der sicheren und wirksamen Leistung des Lungpacer-Therapiesystems zur Zwerchfellstimulation (Diaphragm Pacing Therapy System, DPTS) bei Patienten, bei denen eine Beatmungsentwöhnung fehlgeschlagen ist | 15.11.18 | 03.01.23 | |||
| 50.934 | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS EFZOFITIMOD IN PATIENTS WITH 2023-506039-13 | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS EFZOFITIMOD IN PATIENTS WITH 2023-506039-13 | DPLD | Pulmonary Sarcoidosis | BREATH | Active / not recruiting | 2023-506039-13 | 2023-506039-13 | Interventional | DZL recruiting center | Externally - industry | This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. | This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. | 26.01.24 | 03.07.25 | |||
| 50.963 | A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis | A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis | DPLD | Pulmonary Sarcoidosis | BREATH | Closed | NCT05314517 | 2021-004794-31 | NCT05314517, 2021-004794-31 | Interventional | DZL recruiting center | Externally - industry | To evaluate the effect of namilumab on the need for rescue treatment for worsening of sarcoidosis. | To evaluate the effect of namilumab on the need for rescue treatment for worsening of sarcoidosis. | 24.04.23 | 22.04.24 | ||
| 50.985 | A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension (MACiTEPH); A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent | A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension (MACiTEPH); A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent | PH | Pulmonary Hypertension (WHO Group 4) | BREATH, TLRC, UGMLC | Terminated | NCT04271475 | 2019-004131-24 | NCT04271475, 2019-004131-24 | Interventional | DZL recruiting center | Externally - industry | The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH). | The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH). | 01.07.20 | 01.04.24 | ||
| 50.987 | A Study to Find Out if Selexipag is Effective and Safe in Patients With CTEPH When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment (SELECT) | A Study to Find Out if Selexipag is Effective and Safe in Patients With CTEPH When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment (SELECT) | PH | Pulmonary Hypertension (WHO Group 4) | TLRC, UGMLC | Closed | NCT03689244 | 2014-004786-25 | NCT03689244, 2014-004786-25 | Interventional | DZL recruiting center | Externally - industry | Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH. | Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH. | 01.01.20 | 30.06.22 | ||
| 50.989 | A subject and investigator blinded, randomized, placebocontrolled, repeat-dose, multicenter study to investigate efficacy, safety, and tolerability of CMK389 in patients with chronic pulmonary sarcoidosis | A subject and investigator blinded, randomized, placebocontrolled, repeat-dose, multicenter study to investigate efficacy, safety, and tolerability of CMK389 in patients with chronic pulmonary sarcoidosis | DPLD | Pulmonary Sarcoidosis | BIH / Charité - Associated Partner, BREATH | Closed | 2018-000381-11 | 2018-000381-11 | Interventional | DZL recruiting center | Externally - industry | The purpose of this proof-of-concept study is to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis | The purpose of this proof-of-concept study is to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis | 11.08.20 | 06.12.23 | |||
| 51.006 | An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) | An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) | PH | Pulmonary Hypertension (WHO Group 3, associated with ILD) | TLRC, UGMLC | Closed | NCT05649722 | 2023-505540-19-00 | NCT05649722, 2023-505540-19-00 | Interventional | DZL recruiting center, DZL discovery-based | Externally - industry | The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD. | The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD. | 01.05.23 | 31.03.26 | ||
| 51.169 | SPACE / AIO-TRK-0119 | SPACE / AIO-TRK-0119 | LC | SCLC | CPC-M | Closed | NCT04221529 | 2019-001707-21 | NCT04221529, 2019-001707-21 | Interventional | DZL recruiting center | Externally - public | Single-Arm Phase II-Study in Patients with extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status receiving Atezolizumab-Carboplatin-Etoposide | Single-Arm Phase II-Study in Patients with extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status receiving Atezolizumab-Carboplatin-Etoposide | 06.01.20 | 30.11.24 | ||
| 51.382 | A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (RVT-2301-201; PHocus) | A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (RVT-2301-201; PHocus) | PH | pulmonary hypertension associated with interstitial lung disease (PH-ILD) | TLRC | Recruiting | NCT06635850 | 2024-513991-16 | NCT06635850, 2024-513991-16 | Interventional | DZL recruiting center | Externally - industry | This study is a randomized, double-blind, placebo-controlled study with an extension. The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks). Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period. All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat. | This study is a randomized, double-blind, placebo-controlled study with an extension. The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks). Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period. All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat. | 01.02.25 | 31.01.28 | ||
| 50.982 | A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (CADENCE); A Phase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF) | A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (CADENCE); A Phase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF) | PH | Pulmonary Hypertension (WHO Group 2); Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction | BREATH, TLRC, UGMLC | Recruiting | NCT04945460 | 2021-003020-32 | NCT04945460, 2021-003020-32 | Interventional | DZL recruiting center | Externally - industry | This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint). | This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint). | 01.12.22 | 31.10.25 | ||
| 50.986 | A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (INS1009-211) | A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (INS1009-211) | PH | Pulmonary Hypertension (WHO Group 3, associated with ILD) | TLRC, UGMLC | Closed | NCT05176951 | 2021-003294-66 | NCT05176951, 2021-003294-66 | Interventional | DZL discovery-based, DZL recruiting center | Externally - industry | A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease | A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease | 01.12.22 | 31.03.24 | ||
| 51.024 | BMPR2 Mutations and Iron Metabolism in Pulmonary Arterial Hypertension (AMIA) | BMPR2 Mutations and Iron Metabolism in Pulmonary Arterial Hypertension (AMIA) | PH | Pulmonary Hypertension (WHO Group 1) | TLRC | Closed | NCT04086537 | NCT04086537 | Observational | DZL Investigator Initiated Trial | DZL | The primary objective of the study is to determine whether a correlation between levels of the iron hormone hepcidin and BMPR2 expression levels in blood of PAH patients with and without a BMPR2 mutation compared to healthy controls. | The primary objective of the study is to determine whether a correlation between levels of the iron hormone hepcidin and BMPR2 expression levels in blood of PAH patients with and without a BMPR2 mutation compared to healthy controls. | 01.05.19 | 28.02.21 | |||
| 51.037 | Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension | Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension | PH | Pulmonary Hypertension (WHO Group 1) | TLRC, UGMLC | Closed | NCT03904693 | NCT03904693 | Interventional | DZL on steering board, DZL recruiting center | Externally - industry | This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC. | This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC. | 01.07.19 | 30.09.24 | |||
| 51.041 | COMPERA | COMPERA | PH | Pulmonary Hypertension (WHO Group 1-5) | TLRC, UGMLC | Recruiting | NCT01347216 | NCT01347216 | Observational | DZL on steering board, DZL recruiting center | Externally - industry | The ongoing COMPERA registry prospectively documents consecutive patients with newly initiated treatment of PAH/PAH since May 2007. The internet-based registry fulfills high quality standards through several measures (planned minimum centre contribution of at least 10 patients per year, automated plausibility checks of data at entry, queries, monitoring with source data verification in >50% of participating centers). It can be applied, among further purposes, for quality assurance: individual centers can confidentially compare their results with the combined outcome of other centers and the recommendations from guidelines. | The ongoing COMPERA registry prospectively documents consecutive patients with newly initiated treatment of PAH/PAH since May 2007. The internet-based registry fulfills high quality standards through several measures (planned minimum centre contribution of at least 10 patients per year, automated plausibility checks of data at entry, queries, monitoring with source data verification in >50% of participating centers). It can be applied, among further purposes, for quality assurance: individual centers can confidentially compare their results with the combined outcome of other centers and the recommendations from guidelines. | 01.07.07 | 30.06.26 | |||
| 51.075 | Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension (EXERTION) | Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension (EXERTION) | PH | Pulmonary Hypertension (WHO Group 1,2,4) | UGMLC | Closed | NCT04663217 | NCT04663217 | Observational | DZL Investigator Initiated Trial, DZL recruiting center | Externally - public | This study aims to investigate the exercise profile in pulmonary hypertension patients with either pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to left heart disease and in disease control. After placement of the Swan-Ganz or Conductance catheter patients will undergo an exercise challenge in semi-supine position until exhaustion | This study aims to investigate the exercise profile in pulmonary hypertension patients with either pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to left heart disease and in disease control. After placement of the Swan-Ganz or Conductance catheter patients will undergo an exercise challenge in semi-supine position until exhaustion | 01.11.20 | 30.11.23 | |||
| 51.081 | Giessen Pulmonary Hypertension Registry and Biobank | Giessen Pulmonary Hypertension Registry and Biobank | PH | Pulmonary Hypertension (WHO Group 1-5) | UGMLC | Recruiting | NCT04145024 | NCT04145024 | Observational | DZL recruiting center, DZL Investigator Initiated Trial | Externally - public | Long-term transplant-free survival and its determinants will be investigated in patients with Pulmonary Hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in Giessen, Germany. | Long-term transplant-free survival and its determinants will be investigated in patients with Pulmonary Hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in Giessen, Germany. | 01.07.93 | 31.07.35 | |||
| 51.088 | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL) | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL) | PH | Pulmonary Hypertension (WHO Group 1) | TLRC, UGMLC | Closed | NCT05557942 | NCT05557942 | Interventional | DZL discovery-based, DZL on steering board | Externally - industry | Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (NCT#05036135) were offered the opportunity to continue into this LTE study. Sub-jects who enrolled in the study were to re-ceive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study. TERMINATED! The while inhaled imatinib was well tolerated, it did not prove to be efficacious. | Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (NCT#05036135) were offered the opportunity to continue into this LTE study. Sub-jects who enrolled in the study were to re-ceive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study. TERMINATED! The while inhaled imatinib was well tolerated, it did not prove to be efficacious. | 01.11.22 | 31.08.24 | |||
| 51.117 | MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 in Adults With PH-COPD | MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 in Adults With PH-COPD | PH | Pulmonary Hypertension (WHO Group 3, associated with COPD) | BREATH, TLRC, UGMLC | Recruiting | NCT05612035 | 2022-501201-13-00 | NCT05612035, 2022-501201-13-00 | Interventional | DZL discovery-based, DZL recruiting center | Externally - industry | A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease. To evaluate the effect of MK-5475 versus placebo on 6-minute walk distance (6MWD) at Week 24 | A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease. To evaluate the effect of MK-5475 versus placebo on 6-minute walk distance (6MWD) at Week 24 | 20.02.23 | 30.04.26 | ||
| 51.122 | Monitoring of the Influence of Approved PH-therapies on RV-PA Coupling | Monitoring of the Influence of Approved PH-therapies on RV-PA Coupling | PH | Pulmonary Hypertension (WHO Group 1, 3 and 4) | UGMLC | Recruiting | NCT05935865 | NCT05935865 | Observational | DZL Investigator Initiated Trial, DZL recruiting center | Externally - public | The goal of this observational study is to learn about the acute (days) changes in right ventricular functions caused by initiation of pharmacological therapies in patients with precapillary pulmonary hypertension. The main question it aims to answer is: Course of afterload and intrinsic contractility through-out the hospital stay Participants will be equipped with a device for continuous monitoring and recording of the right ventricular pressure signal. | The goal of this observational study is to learn about the acute (days) changes in right ventricular functions caused by initiation of pharmacological therapies in patients with precapillary pulmonary hypertension. The main question it aims to answer is: Course of afterload and intrinsic contractility through-out the hospital stay Participants will be equipped with a device for continuous monitoring and recording of the right ventricular pressure signal. | 01.02.23 | 28.02.25 | |||
| 51.152 | PVRI GoDeep Global Deep Phenotyping Meta-Registry for Pulmonary Hypertension (PVRI GoDeep) | PVRI GoDeep Global Deep Phenotyping Meta-Registry for Pulmonary Hypertension (PVRI GoDeep) | PH | Pulmonary Hypertension (WHO Group 1-5) | TLRC, UGMLC | Recruiting | NCT05329714 | NCT05329714 | Observational | DZL Investigator Initiated Trial, DZL recruiting center | Externally - public | PVRI-GoDeep is a PH Meta-Registry, run under the umbrella of the Pulmonary Vascular Research Institute (PVRI). It merges anonymized PH patient related data from various local registries around the world run under the responsibility of PVRI members. It will be operated under the auspices of the University of Giessen/Giessen PH center. Combining deep phenotyping with worldwide outreach, PVRI-GoDeep aims to offer insights into specific geographical and ethnical profiles of PH, to deepen the epidemiological, clinical and molecular understanding of this disease and to promote strategies for improved individualized treatment of PH patients. | PVRI-GoDeep is a PH Meta-Registry, run under the umbrella of the Pulmonary Vascular Research Institute (PVRI). It merges anonymized PH patient related data from various local registries around the world run under the responsibility of PVRI members. It will be operated under the auspices of the University of Giessen/Giessen PH center. Combining deep phenotyping with worldwide outreach, PVRI-GoDeep aims to offer insights into specific geographical and ethnical profiles of PH, to deepen the epidemiological, clinical and molecular understanding of this disease and to promote strategies for improved individualized treatment of PH patients. | 01.01.20 | 30.11.55 | |||
| 51.161 | Right Ventricular Haemodynamic Evaluation and Response to Treatment (RIGHT HEART I) | Right Ventricular Haemodynamic Evaluation and Response to Treatment (RIGHT HEART I) | PH | Pulmonary Hypertension (WHO Group 1) | UGMLC | Closed | NCT03403868 | NCT03403868 | Observational | DZL recruiting center, DZL Investigator Initiated Trial | Externally - public | Mono-center-study to evaluate functional parameters in cardiac MRI, conductance catheter (pressure-volume-loops), echocardiography and right heart catheter in PAH patients and to compare different multi-modal parameters. | Mono-center-study to evaluate functional parameters in cardiac MRI, conductance catheter (pressure-volume-loops), echocardiography and right heart catheter in PAH patients and to compare different multi-modal parameters. | 01.01.16 | 31.12.21 | |||
| 50.895 | A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (SOTERIA); An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH | A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (SOTERIA); An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH | PH | Pulmonary Hypertension (WHO Group 1) | BREATH, TLRC, UGMLC | Recruiting | NCT04796337 | 2020-005061-13 | NCT04796337, 2020-005061-13 | Interventional | DZL recruiting center | Externally - industry | This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in participants with Pulmonary Arterial Hypertension. The primary objective of this open-label, long-term follow-up study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies. | This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in participants with Pulmonary Arterial Hypertension. The primary objective of this open-label, long-term follow-up study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies. | 02.12.21 | 31.12.27 | ||
| 50.905 | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | PH | Pulmonary Hypertension (PH) | BREATH | Closed | 2017-004738-27 | 2017-004738-27 | Interventional | DZL recruiting center | Externally - industry | To evaluate the effect on PVR in WHOfunctional class II-III PAH participantstreated with sotatercept plus SOCcompared with placebo plus SOC | To evaluate the effect on PVR in WHOfunctional class II-III PAH participantstreated with sotatercept plus SOCcompared with placebo plus SOC | 02.12.21 | 28.06.22 | |||
| 50.910 | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension" | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension" | PH | Pulmonary Hypertension (PH) | BREATH | Closed | 2022-500877-15 | 2022-500877-15 | Interventional | DZL recruiting center | Externally - industry | To explore the relationship between genetic variation and response to the treatment(s) administered, and mechanisms of disease. Variation across the human genome may be analyzed for association with clinical data collected in the study. | To explore the relationship between genetic variation and response to the treatment(s) administered, and mechanisms of disease. Variation across the human genome may be analyzed for association with clinical data collected in the study. | 28.07.21 | 06.11.25 | |||
| 50.931 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediateand High-risk PAH Patients; Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (HYPERION) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediateand High-risk PAH Patients; Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (HYPERION) | PH | Pulmonary Hypertension (WHO Group 1) | BREATH, TLRC, UGMLC | Recruiting | NCT04811092 | 2021-000199-12 | NCT04811092, 2021-000199-12 | Interventional | DZL recruiting center | Externally - industry | The objective of this study is to evaluate the effects of sotatercept treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus back-ground PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at inter-mediate or high risk of disease progression. | The objective of this study is to evaluate the effects of sotatercept treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus back-ground PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at inter-mediate or high risk of disease progression. | 22.02.22 | 31.08.26 | ||
| 50.932 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PROSERA) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PROSERA) | PH | Pulmonary Hypertension (WHO Group 1) | BREATH, TLRC, UGMLC | Recruiting | NCT05934526 | 2023-503614-80-00 | NCT05934526, 2023-503614-80-00 | Interventional | DZL discovery-based, DZL on steering board | Externally - industry | The primary objective of the study is to determine the effect of seralutinib vs. placebo on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. | The primary objective of the study is to determine the effect of seralutinib vs. placebo on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. | 01.12.23 | 31.12.25 | ||
| 50.938 | A Phase I, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy | A Phase I, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy | PH | Pulmonary Hypertension (PH) | BREATH | Recruiting | 2023-510452-23-00 | 2023-510452-23-00 | Interventional | DZL recruiting center | Externally - industry | To assess the safety and tolerability of 24 weeks of HS135 SC therapy in patients with PAH. | To assess the safety and tolerability of 24 weeks of HS135 SC therapy in patients with PAH. | 24.10.24 | 31.12.26 | |||
| 50.974 | A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension (CLTP001A12201) | A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension (CLTP001A12201) | PH | Pulmonary arterial hypertension (Group 1) | TLRC | Terminated | NCT05135000 | NCT05135000 | Interventional | DZL recruiting center | Externally - industry | This is a non-confirmatory, randomized, subject- and investigator-blinded, placebo controlled study of LTP001 in PAH participants. Approximately 44 male and female adults with PAH participants will be randomized in a 3:1 ratio of LTP001 active dose to placebo. Participants will be screened for up to 8 weeks followed by 24 weeks of daily dosing with visits approximately every 4 weeks. One follow up visit will also be the end of study visit and occurs approximately 30 days after the end of treatment. Total study duration is approximately 37 weeks from start of screening to end of study visit. If a participant continues into the open-label extension study, then the follow-up visit may be skipped. | This is a non-confirmatory, randomized, subject- and investigator-blinded, placebo controlled study of LTP001 in PAH participants. Approximately 44 male and female adults with PAH participants will be randomized in a 3:1 ratio of LTP001 active dose to placebo. Participants will be screened for up to 8 weeks followed by 24 weeks of daily dosing with visits approximately every 4 weeks. One follow up visit will also be the end of study visit and occurs approximately 30 days after the end of treatment. Total study duration is approximately 37 weeks from start of screening to end of study visit. If a participant continues into the open-label extension study, then the follow-up visit may be skipped. | 01.06.22 | 30.04.24 | |||
| 50.975 | A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination with Background Therapy in Adult Participants with Pulmonary Arterial Hypertension (TROPOS Study) | A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination with Background Therapy in Adult Participants with Pulmonary Arterial Hypertension (TROPOS Study) | PH | Pulmonary Hypertension (PH) | BREATH, TLRC | Active / not recruiting | 2022-502378-17-00 | 2022-502378-17-00 | Interventional | DZL recruiting center | Externally - industry | Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy | Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy | 06.05.24 | 01.02.25 | |||
| 50.979 | A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis" | A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis" | CFBE | Pulmonary Hypertension (PH) | BREATH | Closed | 2019-002840-26 | 2019-002840-26 | Interventional | DZL recruiting center | Externally - industry | The purpose of this study is to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in subjects with bronchiectasis will demonstrate clinical safety and efficacy related to improved mucociliary clearance with reduced bacterial colonization as potential drivers of airway obstruction, reduced airway inflammation, exacerbations and mucus load, improved lung function, clinical symptoms and quality of life to support further development in bronchiectasis | The purpose of this study is to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in subjects with bronchiectasis will demonstrate clinical safety and efficacy related to improved mucociliary clearance with reduced bacterial colonization as potential drivers of airway obstruction, reduced airway inflammation, exacerbations and mucus load, improved lung function, clinical symptoms and quality of life to support further development in bronchiectasis | 28.09.21 | 01.09.23 | |||
| 50.980 | A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (CIPHER) | A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (CIPHER) | PH | Pulmonary Hypertension (WHO Group 1) | TLRC, UGMLC | Closed | NCT04193046 | NCT04193046 | Interventional | DZL recruiting center | Externally - industry | The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH. | The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH. | 01.12.19 | 28.02.22 | |||
| 50.981 | A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (IMPAHCT) | A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (IMPAHCT) | PH | Pulmonary Hypertension (WHO Group 1) | TLRC, UGMLC | Closed | NCT05036135 | NCT05036135 | Interventional | DZL discovery-based, DZL on steering board | Externally - industry | IMPAHCT is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with PAH. The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the place-bo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary end-point will be the placebo corrected change in 6-minute walk distance after 24 weeks of treatment. TERMINATED! The while inhaled imatinib was well tolerated, it did not prove to be efficacious. | IMPAHCT is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with PAH. The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the place-bo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary end-point will be the placebo corrected change in 6-minute walk distance after 24 weeks of treatment. TERMINATED! The while inhaled imatinib was well tolerated, it did not prove to be efficacious. | 01.12.22 | 31.08.24 | |||
| 50.983 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11) (STELLAR) | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11) (STELLAR) | PH | Pulmonary Hypertension (WHO Group 1) | BREATH, TLRC, UGMLC | Closed | NCT04576988 | 2020-004142-11 | NCT04576988, 2020-004142-11 | Interventional | DZL recruiting center | Externally - industry | The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo. | The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo. | 01.01.21 | 03.04.23 | ||
| 50.984 | A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) | A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) | PH | Pulmonary Hypertension (WHO Group 1) | TLRC, UGMLC | Closed | NCT04896008 | 2021-001498-21 | NCT04896008, 2021-001498-21 | Interventional | DZL recruiting center | Externally - industry | The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality who are FC II or III. | The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality who are FC II or III. | 01.12.21 | 30.11.25 | ||
| 50.988 | A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (TROPOS Study). | A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (TROPOS Study). | PH | Pulmonary Hypertension (WHO Group 1) | TLRC, UGMLC | Closed | NCT05975905 | NCT05975905 | Interventional | DZL on steering board | Externally - industry | Study KER-012-A201 is Phase 2, double-blind, randomized, placebo-controlled study to determine the efficacy and safety of KER-012 compared to Placebo in adults with PAH (WHO Group 1 PH) on stable background PAH therapy. The study is divided into the Screening Period, Treatment Period, Extension Period, and Follow-Up Period. | Study KER-012-A201 is Phase 2, double-blind, randomized, placebo-controlled study to determine the efficacy and safety of KER-012 compared to Placebo in adults with PAH (WHO Group 1 PH) on stable background PAH therapy. The study is divided into the Screening Period, Treatment Period, Extension Period, and Follow-Up Period. | 01.11.23 | 30.06.25 | |||
| 51.009 | An Open-label Extension Study to Investigate Efficacy, Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension (CLTP001A12201E1) | An Open-label Extension Study to Investigate Efficacy, Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension (CLTP001A12201E1) | PH | Pulmonary arterial hypertension (Group 1) | TLRC | Closed | NCT05764265 | 2022-002007-38 | NCT05764265, 2022-002007-38 | Interventional | DZL recruiting center | Externally - industry | This is a non-randomized, open-label extension study of LTP001 for participants with PAH who complete the parent study CLTP001A12201. Eligible participants will be presented with the opportunity to enroll in the extension study at the end of treatment visit of the parent study. Participants in the extension study will receive a once daily dose of LTP001 for 52 weeks regardless of their parent study treatment (i.e. LTP001 or placebo). Visits to assess the safety, tolerability and efficacy of LTP001 will take place at Weeks 5, 13, 26, 39 and 52, including a right heart catheterization at Week 26 and a 6-minute walk test and echocardiography at Weeks 26 and 52. Participants will have safety follow-up phone calls at week 9 and 17, and may be invited for unscheduled assessments at the site if deemed necessary. At Week 56, approximately 30 days after the treatment period, participants will have one safety follow-up phone call. The safety and efficacy profile of LTP001 observed in this extension study as well as the parent study will determine the continuation of the extension study | This is a non-randomized, open-label extension study of LTP001 for participants with PAH who complete the parent study CLTP001A12201. Eligible participants will be presented with the opportunity to enroll in the extension study at the end of treatment visit of the parent study. Participants in the extension study will receive a once daily dose of LTP001 for 52 weeks regardless of their parent study treatment (i.e. LTP001 or placebo). Visits to assess the safety, tolerability and efficacy of LTP001 will take place at Weeks 5, 13, 26, 39 and 52, including a right heart catheterization at Week 26 and a 6-minute walk test and echocardiography at Weeks 26 and 52. Participants will have safety follow-up phone calls at week 9 and 17, and may be invited for unscheduled assessments at the site if deemed necessary. At Week 56, approximately 30 days after the treatment period, participants will have one safety follow-up phone call. The safety and efficacy profile of LTP001 observed in this extension study as well as the parent study will determine the continuation of the extension study | 01.03.23 | 31.05.24 | ||
| 51.011 | An Open-label, Prospective, Single Centre Study of the Effects of Riociguat on RIght VEntricular Size and Function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension (2020-06RCT) (RIVER II) | An Open-label, Prospective, Single Centre Study of the Effects of Riociguat on RIght VEntricular Size and Function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension (2020-06RCT) (RIVER II) | PH | Pulmonary arterial hypertension (Group 1) and Chronic thromboembolic pulmonary hypertension (Group 4) | TLRC | Recruiting | NCT04954742 | NCT04954742 | Interventional | DZL Investigator Initiated Trial | Externally - industry | Right heart size and function are of utmost prognostic importance in PAH/CTEPH. RV performance measured by echocardiography and enlarged RA area have been shown to be independent prognostic factors in PAH. Recently, a retrospective single centre study has shown that riociguat treatment was associated with a significant reduction of RV and RA area after 3, 6 and 12 months compared to baseline. RA area significantly decreased after 12 months and RV systolic function assessed with tricuspid annular plane systolic excursion (TAPSE) improved after 6 and 12 months of riociguat therapy. The results were confirmed by a recent retrospective multicentre study. It is therefore reasonable to assume a beneficial effect of riociguat on right heart size and function. The primary efficacy endpoint in this study is the change in RV and RA area from baseline to 24 weeks. Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability. Patients who discontinue medication prematurely will be asked to continue with study assessments and perform study visits as outlined in the protocol. Medical examinations comprise medical history, physical examination, electrocardiogram (ECG), blood gas analyses, lung function tests, laboratory testing (including NT-proBNP), echocardiography at rest, and right heart catheterization (RHC) according to clinical practice of the PH centre. The prospective period of data collection comprises a 24-week study period a follow-up phase of about 30±7 days. Outcome (survival and transplant-free survival) of all patients will be assessed when the last patient has terminated his/her 24-week observation period. | Right heart size and function are of utmost prognostic importance in PAH/CTEPH. RV performance measured by echocardiography and enlarged RA area have been shown to be independent prognostic factors in PAH. Recently, a retrospective single centre study has shown that riociguat treatment was associated with a significant reduction of RV and RA area after 3, 6 and 12 months compared to baseline. RA area significantly decreased after 12 months and RV systolic function assessed with tricuspid annular plane systolic excursion (TAPSE) improved after 6 and 12 months of riociguat therapy. The results were confirmed by a recent retrospective multicentre study. It is therefore reasonable to assume a beneficial effect of riociguat on right heart size and function. The primary efficacy endpoint in this study is the change in RV and RA area from baseline to 24 weeks. Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability. Patients who discontinue medication prematurely will be asked to continue with study assessments and perform study visits as outlined in the protocol. Medical examinations comprise medical history, physical examination, electrocardiogram (ECG), blood gas analyses, lung function tests, laboratory testing (including NT-proBNP), echocardiography at rest, and right heart catheterization (RHC) according to clinical practice of the PH centre. The prospective period of data collection comprises a 24-week study period a follow-up phase of about 30±7 days. Outcome (survival and transplant-free survival) of all patients will be assessed when the last patient has terminated his/her 24-week observation period. | 01.04.22 | 31.03.26 | |||
| 51.025 | BMPR2-Signalweg-Expression bei verschiedenen Patientengruppen mit pulmonal arterieller Hypertonie [BMPR2-pathway expression in distinct patient groups with pulmonary arterial hypertension] | BMPR2-Signalweg-Expression bei verschiedenen Patientengruppen mit pulmonal arterieller Hypertonie [BMPR2-pathway expression in distinct patient groups with pulmonary arterial hypertension] | PH | Pulmonary Hypertension (WHO Group 1 & Group 4) | TLRC | Closed | DRKS00030577 | DRKS00030577 | Observational | DZL Investigator Initiated Trial | DZL | The primary objective of the study is to determine the BMPR2 mRNA expression of PAH and CTEPH patients compared to healthy controls. | The primary objective of the study is to determine the BMPR2 mRNA expression of PAH and CTEPH patients compared to healthy controls. | 01.10.22 | 31.10.25 | |||
| 51.065 | Eisen (Fehl-)Resorption bei Patienten mit pulmonal-arterieller Hypertonie [Iron-mal-absorption in patients with pulmonary arterial hypertension] | Eisen (Fehl-)Resorption bei Patienten mit pulmonal-arterieller Hypertonie [Iron-mal-absorption in patients with pulmonary arterial hypertension] | PH | Pulmonary Hypertension (WHO Group 1) | TLRC | Closed | DRKS00032944 | DRKS00032944 | Observational | DZL Investigator Initiated Trial | DZL | The primary objective of the study is to determine the iron resorption of oral iron in PAH patients with and without iron deficiency and healthy controls measured by a standardized iron absorption test (change from baseline to 3 hours post iron supplementation). Blood iron and further iron parameters are assessed at baseline and 3 hours after the intake of 200 mg Fe2+. | The primary objective of the study is to determine the iron resorption of oral iron in PAH patients with and without iron deficiency and healthy controls measured by a standardized iron absorption test (change from baseline to 3 hours post iron supplementation). Blood iron and further iron parameters are assessed at baseline and 3 hours after the intake of 200 mg Fe2+. | 01.11.23 | 31.05.25 | |||
| 51.148 | Prospective, multicenter, non-interventional study in patients with pulmonary arterial hypertension to assess factors that affect treatment decisions and patient’s clinical outcome in a real-world setting | Prospective, multicenter, non-interventional study in patients with pulmonary arterial hypertension to assess factors that affect treatment decisions and patient’s clinical outcome in a real-world setting | PH | Pulmonary Hypertension (PH) | BREATH | Closed | Observational | DZL recruiting center | Externally - industry | This study aims to describe the clinical decision-making, especially the reasons for physician’s treatment decisions, and its translation into clinical outcomes including changes in risk profiles, clinical status and quality of life in PAH patients. | This study aims to describe the clinical decision-making, especially the reasons for physician’s treatment decisions, and its translation into clinical outcomes including changes in risk profiles, clinical status and quality of life in PAH patients. | 29.04.21 | 31.05.24 | |||||
| 51.160 | RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment | RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment | PH | Pulmonary Hypertension (WHO Group 1) | UGMLC | Recruiting | NCT03362047 | 2015-002835-17 | NCT03362047, 2015-002835-17 | Interventional | DZL recruiting center, DZL Investigator Initiated Trial | DZL | In this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan shall be determined by evaluating the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.The method used to determine the RV function will be the "Conductance Method". | In this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan shall be determined by evaluating the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.The method used to determine the RV function will be the "Conductance Method". | 01.03.18 | 31.01.25 | ||
| 50.908 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial hypertension (PAH) | PH | Pulmonary arterial hypertension (Group 1) | BREATH, TLRC | Closed | NCT04456998 | 2019-002669-37 | NCT04456998, 2019-002669-37 | Interventional | DZL recruiting center | Externally - industry | The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population. | The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population. | 01.03.21 | 30.06.23 | ||
| 50.911 | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension | PH | Pulmonary arterial hypertension (Group 1) | TLRC | Closed | NCT04732221 | 2020-001108-40 | NCT04732221, 2020-001108-40 | Interventional | DZL recruiting center | Externally - industry | This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH). The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12. The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12. | This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH). The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12. The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12. | 01.05.21 | 30.07.24 | ||
| 50.912 | A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension (INS1009-202) | A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension (INS1009-202) | PH | Pulmonary arterial hypertension (Group 1) | TLRC | Closed | NCT05147805 | 2021-001528-16, 2023-505541-99-00 | NCT05147805, 2021-001528-16, 2023-505541-99-00 | Interventional | DZL recruiting center | Externally - industry | The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance. | The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance. | 01.08.22 | 31.07.25 | ||
| 50.970 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF) | A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF) | DPLD | Progressive Pulmonary Fibrosis | BREATH | Recruiting | 2023-508429-29-00 | 2023-508429-29-00 | Interventional | DZL recruiting center | Externally - industry | To evaluate the effect of AP01 100 mg given twice daily (BID) and AP01 50 mg BID compared to AP01 placebo (hereafter referred to as placebo) on lung function over 52 weeks in subjects with PPF | To evaluate the effect of AP01 100 mg given twice daily (BID) and AP01 50 mg BID compared to AP01 placebo (hereafter referred to as placebo) on lung function over 52 weeks in subjects with PPF | 04.11.24 | 30.11.25 | |||
| 50.977 | A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with moderate or severe COVID-19.; Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia (TRICOVID) Phase III, randomized, placebo-controlled, double-blind, multi-center | A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with moderate or severe COVID-19.; Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia (TRICOVID) Phase III, randomized, placebo-controlled, double-blind, multi-center | PALI | Pneumonia and Acute Lung Injury, COVID-19 | BIH / Charité - Associated Partner, BREATH | Active / not recruiting | NCT05531149 | 2022-000736-37 | NCT05531149, 2022-000736-37 | Interventional | DZL recruiting center | Externally - industry | The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin. | The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin. | 26.01.23 | 01.01.26 | ||
| 50.997 | AGNES-19: Adrecizumab (HAM8101) to improve prognosis and outcomes in Covid-19 trial | AGNES-19: Adrecizumab (HAM8101) to improve prognosis and outcomes in Covid-19 trial | PALI | Pneumonia and Acute Lung Injury, moderate to severe COVID-19 | BIH / Charité - Associated Partner, BREATH | Closed | NCT05156671 | 2020-001336-10 | NCT05156671, 2020-001336-10 | Interventional | DZL recruiting center | Externally - public | The primary objective of the AGNES-19 trial is to evaluate if improvement of vascular integrity with Adrecizumab on top of standard of care (SOC) is superior to placebo/ control substance (NaCl 0.9%) on top of SOC in reduction of the endpoint ”time to clinical improvement” until day 28 in patients with moderate to severe COVID-19. The secondary objectives of the AGNES-19 trial intend to evaluate the effect of Adrecizumab in com-parison to placebo, with respect to safety and tolerability of Adrecizumab on top of SOC in patients with moderate to severe COVID-19, clinical status at day 28, all-cause mortality, rate of new invasive mechanical ventilation, length of invasive mechanical ventilation, length of initial stay at ICU, rate of renal replacement therapy, change in SOFA score, clinical status according to ordinal WHO scale for COVID-19, and life quality as assessed by EQ5D. | The primary objective of the AGNES-19 trial is to evaluate if improvement of vascular integrity with Adrecizumab on top of standard of care (SOC) is superior to placebo/ control substance (NaCl 0.9%) on top of SOC in reduction of the endpoint ”time to clinical improvement” until day 28 in patients with moderate to severe COVID-19. The secondary objectives of the AGNES-19 trial intend to evaluate the effect of Adrecizumab in com-parison to placebo, with respect to safety and tolerability of Adrecizumab on top of SOC in patients with moderate to severe COVID-19, clinical status at day 28, all-cause mortality, rate of new invasive mechanical ventilation, length of invasive mechanical ventilation, length of initial stay at ICU, rate of renal replacement therapy, change in SOFA score, clinical status according to ordinal WHO scale for COVID-19, and life quality as assessed by EQ5D. | 21.09.22 | 31.08.24 | ||
| 51.007 | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | PH | Pulmonary arterial hypertension (Group 1) | TLRC | Closed | NCT04816604 | 2020-005169-15 | NCT04816604, 2020-005169-15 | Interventional | DZL recruiting center | Externally - industry | This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study. | This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study. | 01.12.21 | 31.12.27 | ||
| 51.008 | An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension (INS1009-203) | An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension (INS1009-203) | PH | Pulmonary arterial hypertension (Group 1) | TLRC | Recruiting | NCT05649748 | 2022-001951-18, 2023-505539-11-00 | NCT05649748, 2022-001951-18, 2023-505539-11-00 | Interventional | DZL recruiting center | Externally - industry | The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH | The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH | 01.05.23 | 31.03.26 | ||
| 51.057 | Effect of acyclovir therapy on the outcome of mechanically ventilated patients with lower respiratory tract infection and detection of herpes simplex virus in bronchoalveolar lavage (HerpMV) | Effect of acyclovir therapy on the outcome of mechanically ventilated patients with lower respiratory tract infection and detection of herpes simplex virus in bronchoalveolar lavage (HerpMV) | PALI | Pneumonia and Acute Lung Injury | Associated Partner | Recruiting | NCT06134492 | NCT06134492 | Interventional | DZL recruiting center | Externally - public | Herpes simplex virus (HSV) is frequently detected in the respiratory tract of mechanically ventilated patients and is associated with a worse outcome. The aim of this study is to determine whether antiviral therapy in HSV-positive patients improves outcome. Prospective, multicentre, open-label, randomised, controlled trial in parallel-group design. Adult, mechanically ventilated patients with pneumonia and HSV type 1 detected in bronchoalveolar lavage (≥105 copies/mL) are eligible for participation and will be randomly allocated (1:1) to receive acyclovir (10 mg/kg body weight every 8 hours) for 10 days (or until discharge from the intensive care unit if earlier) or no intervention (control group). The primary outcome is mortality measured at day 30 after randomisation (primary endpoint) and will be analysed with Cox mixed-effects model. Secondary endpoints include ventilator-free and vasopressor-free days up to day 30. A total of 710 patients will be included in the trial. | Herpes simplex virus (HSV) is frequently detected in the respiratory tract of mechanically ventilated patients and is associated with a worse outcome. The aim of this study is to determine whether antiviral therapy in HSV-positive patients improves outcome. Prospective, multicentre, open-label, randomised, controlled trial in parallel-group design. Adult, mechanically ventilated patients with pneumonia and HSV type 1 detected in bronchoalveolar lavage (≥105 copies/mL) are eligible for participation and will be randomly allocated (1:1) to receive acyclovir (10 mg/kg body weight every 8 hours) for 10 days (or until discharge from the intensive care unit if earlier) or no intervention (control group). The primary outcome is mortality measured at day 30 after randomisation (primary endpoint) and will be analysed with Cox mixed-effects model. Secondary endpoints include ventilator-free and vasopressor-free days up to day 30. A total of 710 patients will be included in the trial. | 01.03.24 | 01.09.26 | |||
| 51.082 | GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study | GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study | PALI | pneumonia-associated ARDS | BREATH, UGMLC | Closed | NCT02595060 | 2014-002479-28 | NCT02595060, 2014-002479-28 | Interventional | DZL Investigator Initiated Trial | DZL, Externally - public, Externally - industry | This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients with pneumonia associated acute respiratory distress syndrome (ARDS). A third of the patients will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will receive inhaled placebo for 3 days. The patients will be followed for 28 days. | This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients with pneumonia associated acute respiratory distress syndrome (ARDS). A third of the patients will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will receive inhaled placebo for 3 days. The patients will be followed for 28 days. | 01.06.16 | 31.07.22 | ||
| 51.094 | International Primary Ciliary Dyskinesia (PCD) Registry (PCDregistry) | International Primary Ciliary Dyskinesia (PCD) Registry (PCDregistry) | CFBE | Primary Ciliary Dyskinesia | BIH / Charité - Associated Partner, TLRC | Recruiting | NCT02419365 | NCT02419365 | Observational | DZL recruiting center | DZL | The purpose of the international prospective PCD Patient Registry is to systematically measure, survey and compare different aspects of PCD manifestation, course and treatment, to provide data for epidemiological research and to identify special patient groups suitable for multi-center trials. | The purpose of the international prospective PCD Patient Registry is to systematically measure, survey and compare different aspects of PCD manifestation, course and treatment, to provide data for epidemiological research and to identify special patient groups suitable for multi-center trials. | 28.10.19 | 01.05.50 | |||
| 51.096 | INvestigating SIGnificant Health TrendS in Management of Progressive Fibrosing Interstitial Lung Disease | INvestigating SIGnificant Health TrendS in Management of Progressive Fibrosing Interstitial Lung Disease | DPLD | Progressive Fibrosing Interstitial Lung Disease | BREATH | Recruiting | Observational | DZL recruiting center | Externally - public | To compare various PF-ILD groups and treatment strategies with each other (and with the IPF cohort from INSIGHTS-IPF) in terms of characteristics and outcomes (lung function, survival, quality of life, other). | To compare various PF-ILD groups and treatment strategies with each other (and with the IPF cohort from INSIGHTS-IPF) in terms of characteristics and outcomes (lung function, survival, quality of life, other). | 01.06.22 | 31.12.25 | |||||
| 51.111 | Longitudinal study without an investigational medicinal product in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) to evaluate novel imaging-based biomarkers in comparison with lung function for use in early clinical development | Longitudinal study without an investigational medicinal product in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) to evaluate novel imaging-based biomarkers in comparison with lung function for use in early clinical development | DPLD, PLI, PLB | Progressive Fibrosing Interstitial Lung Disease | BREATH | Recruiting | Observational | DZL recruiting center | Externally - industry | The main objectives of the study are to assess the annual lung function change in patients with progressive fibrosing interstitial lung disease (PF-ILD) including idiopathic pulmonary fibrosis (IPF), with Usual Interstitial Pneumonia (UIP) or probable UIP CT pattern, and to monitor lung structural changes. | The main objectives of the study are to assess the annual lung function change in patients with progressive fibrosing interstitial lung disease (PF-ILD) including idiopathic pulmonary fibrosis (IPF), with Usual Interstitial Pneumonia (UIP) or probable UIP CT pattern, and to monitor lung structural changes. | 16.12.22 | 31.12.25 | |||||
| 51.124 | Move-PCD – A multi-center longitudinal randomized controlled trial on the effect of a 6-month individualized and supervised physical activity (PA) program on quality of life (QoL) in children, adolescents, and adults with primary ciliary dyskinesia | Move-PCD – A multi-center longitudinal randomized controlled trial on the effect of a 6-month individualized and supervised physical activity (PA) program on quality of life (QoL) in children, adolescents, and adults with primary ciliary dyskinesia | CFBE, DPLD | Primary Ciliary Dyskinesia | BIH / Charité - Associated Partner, ARCN, BREATH | Recruiting | DRKS00033030 | DRKS00033030 | Interventional | DZL recruiting center | Externally - public | A multi-centre longitudinal randomised controlled trial on the effect of a 6-month individualised and supervised physical activity programme on quality of life in children, adolescents and adults with Primary Ciliary Dyskinesia. To improve quality of life after 6 months of supervised and individual physical activity. | A multi-centre longitudinal randomised controlled trial on the effect of a 6-month individualised and supervised physical activity programme on quality of life in children, adolescents and adults with Primary Ciliary Dyskinesia. To improve quality of life after 6 months of supervised and individual physical activity. | 04.12.23 | 30.06.26 | |||
| 51.126 | NAPKON - Nationales Pandemie Kohorten Netz - Hochauflösende Plattform (HAP) - Analysis of pathophysiology and pathology of coronavirus disease 2019 (COVID-19), including chronic morbidity Observational cohort study | NAPKON - Nationales Pandemie Kohorten Netz - Hochauflösende Plattform (HAP) - Analysis of pathophysiology and pathology of coronavirus disease 2019 (COVID-19), including chronic morbidity Observational cohort study | PALI | Pneumonia and Acute Lung Injury | BIH / Charité - Associated Partner | Closed | NCT04747366 | NCT04747366 | Observational | DZL recruiting center | DZL, Externally - public | The severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) pandemic causes a high burden of acute and long-term morbidity and mortality worldwide despite global efforts in containment, prophylaxis, and therapy. With unprecedented speed, the global scientific community has generated pivotal insights into the pathogen and the host response evoked by the infection. However, deeper characterization of the pathophysiology and pathology remains a high priority to reduce morbidity and mortality of coronavirus disease 2019 (COVID-19). NAPKON-HAP is a multi-centered prospective observational study with a long-term follow-up phase of up to 36 months post-SARS-CoV-2 infection. It constitutes a central platform for harmonized data and biospecimen for interdisciplinary characterization of acute SARS-CoV-2 infection and long-term outcomes of diverging disease severities of hospitalized patients. Primary outcome measures include clinical scores and quality of life assessment captured during hospitalization and at outpatient follow-up visits to assess acute and chronic morbidity. Secondary measures include results of biomolecular and immunological investigations and assessment of organ-specific involvement during and post-COVID-19 infection. NAPKON-HAP constitutes a national platform to provide accessibility and usability of the comprehensive data and biospecimen collection to global research. NAPKON-HAP establishes a platform with standardized high-resolution data and biospecimen collection of hospitalized COVID-19 patients of different disease severities in Germany. With this study, we will add significant scientific insights and provide high-quality data to aid researchers to investigate COVID-19 pathophysiology, pathology, and chronic morbidity. | The severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) pandemic causes a high burden of acute and long-term morbidity and mortality worldwide despite global efforts in containment, prophylaxis, and therapy. With unprecedented speed, the global scientific community has generated pivotal insights into the pathogen and the host response evoked by the infection. However, deeper characterization of the pathophysiology and pathology remains a high priority to reduce morbidity and mortality of coronavirus disease 2019 (COVID-19). NAPKON-HAP is a multi-centered prospective observational study with a long-term follow-up phase of up to 36 months post-SARS-CoV-2 infection. It constitutes a central platform for harmonized data and biospecimen for interdisciplinary characterization of acute SARS-CoV-2 infection and long-term outcomes of diverging disease severities of hospitalized patients. Primary outcome measures include clinical scores and quality of life assessment captured during hospitalization and at outpatient follow-up visits to assess acute and chronic morbidity. Secondary measures include results of biomolecular and immunological investigations and assessment of organ-specific involvement during and post-COVID-19 infection. NAPKON-HAP constitutes a national platform to provide accessibility and usability of the comprehensive data and biospecimen collection to global research. NAPKON-HAP establishes a platform with standardized high-resolution data and biospecimen collection of hospitalized COVID-19 patients of different disease severities in Germany. With this study, we will add significant scientific insights and provide high-quality data to aid researchers to investigate COVID-19 pathophysiology, pathology, and chronic morbidity. | 01.01.21 | 31.12.24 | |||
| 51.175 | Tezepelumab (Anti-TSLP-mab) in progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia (Tefibeos) | Tezepelumab (Anti-TSLP-mab) in progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia (Tefibeos) | DPLD | Progressive Pulmonary Fibrosis Interstitial Lung Disease | UGMLC, BREATH | Recruiting | 2024-510884-51 | 2024-510884-51 | Interventional | DZL Investigator Initiated Trial | DZL | This study investigates the treatment of patients with fibrosing interstitial lung disease with the investigational drug tezepelumab. The investigational drug has already been approved for the treatment of severe asthma and is being used successfully in this area. The purpose of this study is to investigate how well tezepelumab is tolerated by the patients concerned and whether treatment with tezepelumab also has advantages over standard therapy in the treatment of fibrosing interstitial lung disease. | This study investigates the treatment of patients with fibrosing interstitial lung disease with the investigational drug tezepelumab. The investigational drug has already been approved for the treatment of severe asthma and is being used successfully in this area. The purpose of this study is to investigate how well tezepelumab is tolerated by the patients concerned and whether treatment with tezepelumab also has advantages over standard therapy in the treatment of fibrosing interstitial lung disease. | 26.02.24 | 31.03.26 | |||
| 51.179 | Thrombolysis Therapy for ARDS – The TRISTARDS trial Phase IIb/III, prospective, randomized, open-label, multi-center; A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19. | Thrombolysis Therapy for ARDS – The TRISTARDS trial Phase IIb/III, prospective, randomized, open-label, multi-center; A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19. | PALI | Pneumonia and Acute Lung Injury, acute respiratory distress syndrome | BIH / Charité - Associated Partner, BREATH | Closed | NCT04640194 | 2020-002913-16 | NCT04640194, 2020-002913-16 | Interventional | DZL recruiting center | Externally - public | A Phase llb/11I operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19. | A Phase llb/11I operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19. | 01.01.21 | 15.11.22 | ||
| 51.379 | Immunadsorption bei Post COVID-Syndrom - EXTINCT Post COVID Studie | Immunadsorption bei Post COVID-Syndrom - EXTINCT Post COVID Studie | PALI | Post-Covid-19 | BREATH | Recruiting | NCT05954325 | NCT05954325 | Interventional | DZL recruiting center | Externally - public | The EXTINCT post COVID study aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome. | The EXTINCT post COVID study aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome. | 15.08.23 | 30.06.25 | |||
| 51.380 | OutreAch MediCal Care for HousEbound Patients with Post-COVID Syndrome or ME/CFS of any cause“(ACCESS) | OutreAch MediCal Care for HousEbound Patients with Post-COVID Syndrome or ME/CFS of any cause“(ACCESS) | PALI | Post-Covid-19 | BREATH | Not yet recruiting | Interventional | DZL recruiting center | Externally - public | Im Rahmen des ACCESS-Projekts soll die Prävalenz der schwersten Manifestation von Post-Covid-Syndrom/ ME/CFS, die klinischen Merkmale, die Differentialdiagnosen, Risikofaktoren und die Auswirkungen der Krankheit auf das Leben der Betroffenen und ihrer Familien/Pflegepersonen ermitteln. Es werden individuelle Pflege- und Behandlungspläne entwickelt, und die Auswirkungen einer monatlichen telemedizinischen Visite von Patient:innen und Betreuer:innen auf den Gesundheitszustand der Patient:innen und die Belastung der Betreuer:innen in einer randomisierten kontrollierten Studie untersucht. Das Projekt wird in enger Zusammenarbeit zwischen Patient:innen, Pflegepersonen, Hausärzt:innen und Expert:innen aus Allgemeinmedizin, Innerer Medizin, Neurologie und Psychosomatik durchgeführt. | Im Rahmen des ACCESS-Projekts soll die Prävalenz der schwersten Manifestation von Post-Covid-Syndrom/ ME/CFS, die klinischen Merkmale, die Differentialdiagnosen, Risikofaktoren und die Auswirkungen der Krankheit auf das Leben der Betroffenen und ihrer Familien/Pflegepersonen ermitteln. Es werden individuelle Pflege- und Behandlungspläne entwickelt, und die Auswirkungen einer monatlichen telemedizinischen Visite von Patient:innen und Betreuer:innen auf den Gesundheitszustand der Patient:innen und die Belastung der Betreuer:innen in einer randomisierten kontrollierten Studie untersucht. Das Projekt wird in enger Zusammenarbeit zwischen Patient:innen, Pflegepersonen, Hausärzt:innen und Expert:innen aus Allgemeinmedizin, Innerer Medizin, Neurologie und Psychosomatik durchgeführt. | 01.01.25 | 31.12.28 | |||||
| 51.381 | Randomisierter Vergleich von telemedizinisch gestützter Psycho- und Bewegungstherapie und deren Kombination bei Post-Covid-19-Syndrom (TELPOCO) | Randomisierter Vergleich von telemedizinisch gestützter Psycho- und Bewegungstherapie und deren Kombination bei Post-Covid-19-Syndrom (TELPOCO) | PALI | Post-Covid-19 | BREATH | Recruiting | NCT06042751 | NCT06042751 | Interventional | DZL recruiting center | Externally - public | Randomisiert-kontrollierte Interventionsstudie zur Erprobung einer telemedizinisch gestützten Psycho- und Bewegungstherapie bei Patient:innen mit Post-Covid-19-Symptomatik. | Randomisiert-kontrollierte Interventionsstudie zur Erprobung einer telemedizinisch gestützten Psycho- und Bewegungstherapie bei Patient:innen mit Post-Covid-19-Symptomatik. | 01.01.24 | 31.12.25 | |||
| 50.891 | 1305-0023 (FIBRONEERTM – ILD): A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) | 1305-0023 (FIBRONEERTM – ILD): A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) | DPLD | PF-ILD | BREATH, CPC-M | Active / not recruiting | 2022-001134-11 | 2022-001134-11 | Interventional | DZL recruiting center | Externally - industry | The purpose of this trial is to evaluate the efficacy, safety, and tolerability of BI 1015550 9 mg bid and 18 mg bid compared to placebo in patients with progressive fibrosing ILDs in addition to patient’s standard of care over the course of at least 52 weeks. New treatments with better tolerability are needed for patients with ILDs to further reduce the decline in lung function and improve quality of life. Based on its anti inflammatory and antifibrotic properties and the preliminary clinical evidence described, BI 1015550 may provide an additional treatment option to patients with progressive pulmonary fibrosis irrespective of concomitant treatment with standard of care. | The purpose of this trial is to evaluate the efficacy, safety, and tolerability of BI 1015550 9 mg bid and 18 mg bid compared to placebo in patients with progressive fibrosing ILDs in addition to patient’s standard of care over the course of at least 52 weeks. New treatments with better tolerability are needed for patients with ILDs to further reduce the decline in lung function and improve quality of life. Based on its anti inflammatory and antifibrotic properties and the preliminary clinical evidence described, BI 1015550 may provide an additional treatment option to patients with progressive pulmonary fibrosis irrespective of concomitant treatment with standard of care. | 15.12.22 | 28.02.25 | |||
| 50.947 | A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso) | A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso) | LC | Pleural Mesothelioma | TLRC | Recruiting | NCT06097728 | 2023-503231-17-00 | NCT06097728, 2023-503231-17-00 | Interventional | DZL recruiting center | Externally - industry | This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma. | This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma. | 09.11.23 | 13.03.28 | ||
| 50.995 | Aerosol-Studie: „Determinanten der Aerosolproduktion der Lunge bei Patienten mit Mukoviszidose: Effekt von Ventilationsrate und Bronchodilatation bei Patienten mit und ohne Tripeltherapie“ | Aerosol-Studie: „Determinanten der Aerosolproduktion der Lunge bei Patienten mit Mukoviszidose: Effekt von Ventilationsrate und Bronchodilatation bei Patienten mit und ohne Tripeltherapie“ | CFBE | Patienten der Mukoviszidose-Ambulanz für Erwachsene | CPC-M | Recruiting | Observational | DZL recruiting center | Externally - public | Viskosität des Sputums ist Faktor für Aerosolproduktion; inwiefern (1) die Strömungsbedingungen in den aerosolpartikelbildenden Teilen der Lunge sowie (2) die Eigenschaften des Flüssigkeitsfilms auf der Oberfläche der Atemwege die Aerosolpartikelproduktion bei Patienten mit Mukoviszidose beeinflussen. | Viskosität des Sputums ist Faktor für Aerosolproduktion; inwiefern (1) die Strömungsbedingungen in den aerosolpartikelbildenden Teilen der Lunge sowie (2) die Eigenschaften des Flüssigkeitsfilms auf der Oberfläche der Atemwege die Aerosolpartikelproduktion bei Patienten mit Mukoviszidose beeinflussen. | 01.01.25 | 31.12.26 | |||||
| 51.002 | ALOFT-PF-ILD IM027-1015: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis | ALOFT-PF-ILD IM027-1015: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis | DPLD | Participants with Progressive Pulmonary Fibrosis | CPC-M | Recruiting | 2023-503699-25-00 | 2023-503699-25-00 | Interventional | DZL recruiting center | Externally - industry | To evaluate the efficacy of 2 doses of BMS-986278, 60 and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at Week 52 in participants with PPF. | To evaluate the efficacy of 2 doses of BMS-986278, 60 and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at Week 52 in participants with PPF. | 01.10.24 | 31.12.25 | |||
| 51.023 | Biomarker in chronischen Lungenerkrankungen | Biomarker in chronischen Lungenerkrankungen | PLB | Patienten mit chronischen und akuten Lungenerkrankungen | CPC-M | Recruiting | Observational | DZL recruiting center, DZL Investigator Initiated Trial | DZL | Probensammlung für das DZL CPC-M bioArchive: Die Untersuchung von Biomarkern in chronischen und akuten Lungenerkrankungen (z.B. COPD, Lungenfibrose, IPF, COVID-19) hat zum Ziel, Reparaturmechanismen, (epi-)genetische Risikoprofile, den Einfluss von oxidativem Stress sowie die Auswirkung früher Lungenverletzungen auf spätere Erkrankungen besser zu verstehen. Weitere Teilstudien umfassen außerdem periphere Biomarker als Indikatoren für die Entwicklung strahleninduzierter Lungenfibrose in Folge einer Krebstherapie sowie Immundefekte im Zusammenhang mit Virusinfektionen, die mit Exazerbationen in COPD-Patienten einhergehen. Zusätzlich sollen diagnostische Biomarker evaluiert werden, um verschiedene Krankheitsentitäten mit ähnlicher klinischer Manifestation, wie z.B. Asthma und COPD, zu unterscheiden. In weiteren Projekten werden Biomarker für die Identifikation von Sub-Phänotypen und Verlaufsüberwachung in chronischen, akuten und malignen Lungenerkrankungen bestimmt. Biomarker dienen auch dazu, Exazerbationen und den Verlauf von chronischen Lungenerkrankungen vorherzusagen, und die Variation der Infektionsanfälligkeit und den Krankheitsverlauf von COVID-19 zu verstehen. | Probensammlung für das DZL CPC-M bioArchive: Die Untersuchung von Biomarkern in chronischen und akuten Lungenerkrankungen (z.B. COPD, Lungenfibrose, IPF, COVID-19) hat zum Ziel, Reparaturmechanismen, (epi-)genetische Risikoprofile, den Einfluss von oxidativem Stress sowie die Auswirkung früher Lungenverletzungen auf spätere Erkrankungen besser zu verstehen. Weitere Teilstudien umfassen außerdem periphere Biomarker als Indikatoren für die Entwicklung strahleninduzierter Lungenfibrose in Folge einer Krebstherapie sowie Immundefekte im Zusammenhang mit Virusinfektionen, die mit Exazerbationen in COPD-Patienten einhergehen. Zusätzlich sollen diagnostische Biomarker evaluiert werden, um verschiedene Krankheitsentitäten mit ähnlicher klinischer Manifestation, wie z.B. Asthma und COPD, zu unterscheiden. In weiteren Projekten werden Biomarker für die Identifikation von Sub-Phänotypen und Verlaufsüberwachung in chronischen, akuten und malignen Lungenerkrankungen bestimmt. Biomarker dienen auch dazu, Exazerbationen und den Verlauf von chronischen Lungenerkrankungen vorherzusagen, und die Variation der Infektionsanfälligkeit und den Krankheitsverlauf von COVID-19 zu verstehen. | 01.08.22 | 31.12.27 | |||||
| 51.026 | BOSTON-3: An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CsA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 studies | BOSTON-3: An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CsA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 studies | ROR, DPLD, COPD | Patienten mit Einzel- oder Doppellungentransplantation | CPC-M | Closed | 2019-002987-29 | 2019-002987-29 | Interventional | DZL recruiting center | Externally - industry | The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients. | The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients. | 12.11.20 | 31.12.26 | |||
| 51.045 | COSYCONET-2: Einfluss systemischer Manifestationen und Komorbiditäten auf den klinischen Zustand und Verlauf bei Patienten mit chronisch-obstruktiver Lungenerkrankung (COPD) | COSYCONET-2: Einfluss systemischer Manifestationen und Komorbiditäten auf den klinischen Zustand und Verlauf bei Patienten mit chronisch-obstruktiver Lungenerkrankung (COPD) | COPD | patients with chronic obstructive pulmonary disease (COPD) | CPC-M | Recruiting | Observational | DZL recruiting center, DZL Investigator Initiated Trial | DZL, Externally - public | Functional impairment and comorbidities. To quantify the importance of extrapulmonary organ manifestations and disorders for the course of COPD and to examine the course of the disease in mild stages of COPD. | Functional impairment and comorbidities. To quantify the importance of extrapulmonary organ manifestations and disorders for the course of COPD and to examine the course of the disease in mild stages of COPD. | 25.08.20 | 31.12.26 | |||||
| 51.048 | CREATING EVIDENCE FOR THE USE OF HYPERTONIC SALINE IN PEOPLE WITH PRIMARY CILIARY DYSKINESIA - HELP-PCD | CREATING EVIDENCE FOR THE USE OF HYPERTONIC SALINE IN PEOPLE WITH PRIMARY CILIARY DYSKINESIA - HELP-PCD | CFBE | PCD | ARCN, BREATH, BIH / Charité - Associated Partner, UGMLC, TLRC, CPC-M | Recruiting | Interventional | DZL Investigator Initiated Trial | DZL | Evaluate efficacy of treatment with nebulized hypertonic saline (6% NaCl, sterile) in pwPCD who are ≥12 years of age by improvement of lung clearance index (LCI) | Evaluate efficacy of treatment with nebulized hypertonic saline (6% NaCl, sterile) in pwPCD who are ≥12 years of age by improvement of lung clearance index (LCI) | 01.02.25 | 31.01.27 | |||||
| 51.061 | Efficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind, Randomized, Multicenter, Multinational, Placebo-controlled Phase IIa Study (ESRA) (2020-01RCT) | Efficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind, Randomized, Multicenter, Multinational, Placebo-controlled Phase IIa Study (ESRA) (2020-01RCT) | PH | Early forms of pulmonary arterial hypertension (PAH), Idiopathic PAH, Heritable PAH, Rheumatoid arthritis (RA) with associated (early) PAH, Connective tissue diseases (CTDs) | TLRC | Recruiting | NCT05339087 | 2021-001633-40 | NCT05339087, 2021-001633-40 | Interventional | DZL Investigator Initiated Trial | Externally - industry | Chronic pulmonary arterial hypertension (PAH) is associated with impaired exercise capacity, quality of life and right ventricular function characterized by an increase of pulmonary vascular resistance (PVR) and pulmonary arterial pressure, leading to right heart insufficiency. Riociguat treatment is approved for both PAH and chronic thromboembolic pulmonary hypertension (CTEPH). Data on early treatment of patients with mildly elevated pulmonary arterial pressures is still scarce but there is evidence that such patients may benefit from early targeted therapy. For instance, in a trial on systemic sclerosis (SSc)-patients with mildly elevated mean pulmonary artery pressure (mPAP) and/or exercise pulmonary hypertension, without significant left heart or lung disease, ambrisentan, an endothelin receptor antagonist resulted in an improvement of PVR as secondary endpoint, which may be of prognostic relevance in this patient cohort and requires further research. Besides its prognostic significance among patients with SSc-APAH, PVR may be an indicator of early pulmonary vascular disease and previous studies proved the positive effects of riociguat on right heart size and PVR (secondary endpoint in phase III studies). Thus, PVR was chosen as primary endpoint of this study aiming to investigate the effect of riociguat (MK-4836) on PVR, clinical parameters, safety and tolerability in patients with early pulmonary vascular disease. Eligible subjects will be randomized in a 1:1 ratio to receive either riociguat or placebo. Medical examinations include medical history, physical examination, electrocardiogram, blood gas analyses, lung function tests, laboratory testing (including NT-proBNP), echocardiography at rest, and right heart catheterization. The prospective period of data collection comprises a 24-week treatment phase diveded into an 8-week titration phase followed by a 16-week main study phase as well as a safety follow-up of 30±14 days. | Chronic pulmonary arterial hypertension (PAH) is associated with impaired exercise capacity, quality of life and right ventricular function characterized by an increase of pulmonary vascular resistance (PVR) and pulmonary arterial pressure, leading to right heart insufficiency. Riociguat treatment is approved for both PAH and chronic thromboembolic pulmonary hypertension (CTEPH). Data on early treatment of patients with mildly elevated pulmonary arterial pressures is still scarce but there is evidence that such patients may benefit from early targeted therapy. For instance, in a trial on systemic sclerosis (SSc)-patients with mildly elevated mean pulmonary artery pressure (mPAP) and/or exercise pulmonary hypertension, without significant left heart or lung disease, ambrisentan, an endothelin receptor antagonist resulted in an improvement of PVR as secondary endpoint, which may be of prognostic relevance in this patient cohort and requires further research. Besides its prognostic significance among patients with SSc-APAH, PVR may be an indicator of early pulmonary vascular disease and previous studies proved the positive effects of riociguat on right heart size and PVR (secondary endpoint in phase III studies). Thus, PVR was chosen as primary endpoint of this study aiming to investigate the effect of riociguat (MK-4836) on PVR, clinical parameters, safety and tolerability in patients with early pulmonary vascular disease. Eligible subjects will be randomized in a 1:1 ratio to receive either riociguat or placebo. Medical examinations include medical history, physical examination, electrocardiogram, blood gas analyses, lung function tests, laboratory testing (including NT-proBNP), echocardiography at rest, and right heart catheterization. The prospective period of data collection comprises a 24-week treatment phase diveded into an 8-week titration phase followed by a 16-week main study phase as well as a safety follow-up of 30±14 days. | 01.10.22 | 30.06.26 | ||
| 51.070 | European ILD Registry and Biobank: eurILDreg | European ILD Registry and Biobank: eurILDreg | DPLD | Interstitielle Lungenerkrankungen (ILD) | CPC-M | Recruiting | DRKS00028968 | DRKS00028968 | Observational | DZL recruiting center | Externally - public | The overall aims of the eurILDreg, in collaboration with the RARE-ILD consortium, are to - describe the natural course of different forms of ILDs - analyse differences in genetically defined forms of ILD between childhood and adulthood - develop novel, primarily non-invasive, diagnostic, prognostic and therapeutic biomarkers, - provide new algorithms for diagnostic workup, longitudinal follow-up and treatment - analyse quality of life in the different ILD cohorts - study the impact of environmental factors on disease initiation and progression - establish the role of exacerbations in the initiation and progression of ILDs - create a most comprehensive, coherent and conclusive set of big data in the field of ILD, including deep phenome, imaginome, epi/genome, proteome, transcriptome, and the volatolome. - analyse this big data set employing artificial intelligence and computational modeling. | The overall aims of the eurILDreg, in collaboration with the RARE-ILD consortium, are to - describe the natural course of different forms of ILDs - analyse differences in genetically defined forms of ILD between childhood and adulthood - develop novel, primarily non-invasive, diagnostic, prognostic and therapeutic biomarkers, - provide new algorithms for diagnostic workup, longitudinal follow-up and treatment - analyse quality of life in the different ILD cohorts - study the impact of environmental factors on disease initiation and progression - establish the role of exacerbations in the initiation and progression of ILDs - create a most comprehensive, coherent and conclusive set of big data in the field of ILD, including deep phenome, imaginome, epi/genome, proteome, transcriptome, and the volatolome. - analyse this big data set employing artificial intelligence and computational modeling. | 18.11.19 | 31.12.26 | |||
| 51.076 | Fibroneer-ON: An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER™-ON) | Fibroneer-ON: An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER™-ON) | DPLD | Patients with IPF or ILD | BREATH, CPC-M | Recruiting | 2023-507353-15-00 | 2023-507353-15-00 | Interventional | DZL recruiting center | DZL, Externally - industry | The main objective is to assess the long-term tolerability, safety, and efficacy of oral BI 1015550 treatment in patients with IPF and other types of PPF who have completed planned treatment (and did not prematurely discontinue trial medication permanently in the pivotal Phase III parent trials, 1305-0014 [FIBRONEER™-IPF] or 1305-0023 [FIBRONEER™-ILD]). | The main objective is to assess the long-term tolerability, safety, and efficacy of oral BI 1015550 treatment in patients with IPF and other types of PPF who have completed planned treatment (and did not prematurely discontinue trial medication permanently in the pivotal Phase III parent trials, 1305-0014 [FIBRONEER™-IPF] or 1305-0023 [FIBRONEER™-ILD]). | 06.09.24 | 31.01.27 | |||
| 51.079 | GALACTIC-1: GALACTIC-1 - A randomized, double-blind, multicentre, parallel, placebo-controlled phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks | GALACTIC-1: GALACTIC-1 - A randomized, double-blind, multicentre, parallel, placebo-controlled phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks | DPLD | Patients with IPF | CPC-M | Closed | 2018-002664-73 | 2018-002664-73 | Interventional | DZL recruiting center | Externally - industry | All subjects enrolled into the study will have a diagnosis of IPF established within the previous five years, and a diagnostic HRCT scan assessed according the ATS/ERS/Fleischner criteria available within the previous 12 months (up to 12 months +27 days). Evaluate the effect of GB0139 dry powder for inhalation compared with placebo over 52 weeks treatment period on the annual rate of decline in FVC in participants with IPF who are not treated with or cannot tolerate nintedanib or pirfenidone. | All subjects enrolled into the study will have a diagnosis of IPF established within the previous five years, and a diagnostic HRCT scan assessed according the ATS/ERS/Fleischner criteria available within the previous 12 months (up to 12 months +27 days). Evaluate the effect of GB0139 dry powder for inhalation compared with placebo over 52 weeks treatment period on the annual rate of decline in FVC in participants with IPF who are not treated with or cannot tolerate nintedanib or pirfenidone. | 01.10.20 | 31.12.22 | |||
| 51.090 | INSIGHTS-ILD Registry: INvestigating SIGnificant Health TrendS in Management of Progressive Fibrosing Interstitial Lung Disease | INSIGHTS-ILD Registry: INvestigating SIGnificant Health TrendS in Management of Progressive Fibrosing Interstitial Lung Disease | DPLD | PF-ILDs, which include all ILD groups including those with IIPs, CTD-ILD, chronic hypersensitivity pneumonitis, asbestosis, sarcoidosis, etc. | CPC-M | Closed | Observational | DZL recruiting center, DZL Investigator Initiated Trial | DZL | To provide comprehensive information on different PF-ILD within routine clinical practice: utilization of medication, efficacy, safety, quality of life and other patient related outcomes (PRO), and economic variables, including post-treatment follow-up. To compare various PF-ILD groups and treatment strategies with each other (and with the IPF cohort from INSIGHTS-IPF) in terms of characteristics and outcomes (lung function, survival, quality of life, other). | To provide comprehensive information on different PF-ILD within routine clinical practice: utilization of medication, efficacy, safety, quality of life and other patient related outcomes (PRO), and economic variables, including post-treatment follow-up. To compare various PF-ILD groups and treatment strategies with each other (and with the IPF cohort from INSIGHTS-IPF) in terms of characteristics and outcomes (lung function, survival, quality of life, other). | 04.01.22 | 31.12.26 | |||||
| 51.104 | Klinisches Register Schweres Asthma: GAN - German Asthma Net e.V. | Klinisches Register Schweres Asthma: GAN - German Asthma Net e.V. | AA | patients with severe asthma | CPC-M | Recruiting | Observational | DZL recruiting center | Externally - public | Information about the disease, response to treatment, disease process | Information about the disease, response to treatment, disease process | 14.06.21 | 31.12.30 | |||||
| 51.120 | MK-7962-024: A Phase 2, Multicenter, Open-label, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care | MK-7962-024: A Phase 2, Multicenter, Open-label, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care | PH | Pulmonary Arterial Hypertension (PAH) | BIH / Charité - Associated Partner, BREATH, TLRC | Recruiting | 2024-512278-92 | 2024-512278-92 | Interventional | DZL recruiting center | Externally - industry | To evaluate the steady state systemic exposure of sotatercept using weight-banded dosing relative to the exposure using weight-based dosing following multiple (maintenance doses) dose administration. Eine multizentrische, einfach verblindete, randomisierte Phase-2-Studie zur Bewertung der Pharmakokinetik und Sicherheit von Sotatercept (MK-7962) bei Teilnehmern mit pulmonaler arterieller Hypertonie (PAH) die mit der Standardtherapie behandelt werden. Die Verabreichung der Studienmedikation erfolgt entweder mit einem gewichtsbasierten oder einem gewichtsgebundenen Ansatz. Bei der gewichtsbasierten Dosierung richtet sich die Dosis des Medikaments nach dem Körpergewicht. Bei der Dosierung nach dem Gewichtsband richtet sich die Dosis der Medikation nach Gewichtsbereichen (Bändern), wobei jedem Band eine andere Dosis zugeordnet ist. Alle Teilnehmer erhalten Sotatercept. Das Medikament wird alle 3 Wochen unter die Haut injiziert. Die Teilnahme an der Studie dauert 9 Monate und umfasst 14 Besuche am Zentrum, sowie einem Telefonkontakt. | To evaluate the steady state systemic exposure of sotatercept using weight-banded dosing relative to the exposure using weight-based dosing following multiple (maintenance doses) dose administration. Eine multizentrische, einfach verblindete, randomisierte Phase-2-Studie zur Bewertung der Pharmakokinetik und Sicherheit von Sotatercept (MK-7962) bei Teilnehmern mit pulmonaler arterieller Hypertonie (PAH) die mit der Standardtherapie behandelt werden. Die Verabreichung der Studienmedikation erfolgt entweder mit einem gewichtsbasierten oder einem gewichtsgebundenen Ansatz. Bei der gewichtsbasierten Dosierung richtet sich die Dosis des Medikaments nach dem Körpergewicht. Bei der Dosierung nach dem Gewichtsband richtet sich die Dosis der Medikation nach Gewichtsbereichen (Bändern), wobei jedem Band eine andere Dosis zugeordnet ist. Alle Teilnehmer erhalten Sotatercept. Das Medikament wird alle 3 Wochen unter die Haut injiziert. Die Teilnahme an der Studie dauert 9 Monate und umfasst 14 Besuche am Zentrum, sowie einem Telefonkontakt. | 14.11.24 | 31.12.26 | |||
| 51.139 | Pathomechanismen chronischer Lungenerkrankungen | Pathomechanismen chronischer Lungenerkrankungen | PLB | Patienten mit chronischen Lungenerkrankungen insbesondere Patienten mit interstitiellen (ILDs), obstruktiven (COPD und Asthma) und vaskulären Lungenerkrankungen, Patienten vor und nach Lungentransplantation sowie Patienten mit einer COVID-19-Infektion und Patienten mit einer tumorösen Lungenerkrankung. | CPC-M | Recruiting | DRKS00028872 | DRKS00028872 | Observational | DZL recruiting center, DZL Investigator Initiated Trial | DZL | Probensammlung für DZL CPC-M bioArchive: Im Rahmen der wissenschaftlichen Arbeiten des Deutschen Zentrums für Lungenforschung (DZL) am Standort München (CPC-M), welcher die folgenden Partner umfasst: das Helmholtz Zentrum München (HMGU), das Klinikum der Universität München (KUM), die Asklepios Biobank für Lungenkrankheiten (ASK) und die Ludwig-Maximilians-Universität München (LMU), werden gemeinsam Pathomechanismen der Erkrankungen erforscht, um in der Zukunft hierdurch diagnostische und therapeutische Möglichkeiten entwickeln zu können. Das vorgelegte Projekt hat zum Ziel in verschiedenen Untersuchungsansätzen und unter Verwendung verschiedener Analysemethoden solche Mechanismen zu identifizieren, die in der Zukunft die Entwicklung neuer diagnostischer und therapeutischer Möglichkeiten für chronische und akute Lungenerkrankungen in translationalen Projekten möglich machen. Wir setzen für die vollständige Erfassung dieser Mechanismen genetische Untersuchungen, molekular- und zellbiologische Analysen ein und verwenden humane Zellkulturen und Gewebeschnitte, das heißt biologisches Material von lungenkranken Patienten und, soweit erhältlich, gesundes Gewebe, das als Kontrolle eingesetzt werden kann. | Probensammlung für DZL CPC-M bioArchive: Im Rahmen der wissenschaftlichen Arbeiten des Deutschen Zentrums für Lungenforschung (DZL) am Standort München (CPC-M), welcher die folgenden Partner umfasst: das Helmholtz Zentrum München (HMGU), das Klinikum der Universität München (KUM), die Asklepios Biobank für Lungenkrankheiten (ASK) und die Ludwig-Maximilians-Universität München (LMU), werden gemeinsam Pathomechanismen der Erkrankungen erforscht, um in der Zukunft hierdurch diagnostische und therapeutische Möglichkeiten entwickeln zu können. Das vorgelegte Projekt hat zum Ziel in verschiedenen Untersuchungsansätzen und unter Verwendung verschiedener Analysemethoden solche Mechanismen zu identifizieren, die in der Zukunft die Entwicklung neuer diagnostischer und therapeutischer Möglichkeiten für chronische und akute Lungenerkrankungen in translationalen Projekten möglich machen. Wir setzen für die vollständige Erfassung dieser Mechanismen genetische Untersuchungen, molekular- und zellbiologische Analysen ein und verwenden humane Zellkulturen und Gewebeschnitte, das heißt biologisches Material von lungenkranken Patienten und, soweit erhältlich, gesundes Gewebe, das als Kontrolle eingesetzt werden kann. | 01.08.22 | 31.12.27 | |||
| 51.150 | Prospektive, längsschnittliche,multizentrische Fall-Kohortenstudie zur Progression der ambulant erworbenen Pneumonie bei Patienten mit schwereren Vorerkrankungen und Immunsuppression zur Ergänzung der PROGRESS CAP-Kohorte (PROGRESS “CAP-Kohorte Komorbidität”) | Prospektive, längsschnittliche,multizentrische Fall-Kohortenstudie zur Progression der ambulant erworbenen Pneumonie bei Patienten mit schwereren Vorerkrankungen und Immunsuppression zur Ergänzung der PROGRESS CAP-Kohorte (PROGRESS “CAP-Kohorte Komorbidität”) | PALI | Pneumonia | UGMLC | Recruiting | Observational | DZL recruiting center | DZL | This study aims for identifying transcriptome- and proteome-based signatures as well as bio-markers and genetic polymorphisms asso-ciated with community- or hospital-acquired pneumonia in CAP patients. Of particular interest are markers of the transition from uncomplicated pneumonia to severe pneumonia and pneumonia with an increased risk of sepsis. By linking well-defined clinical phenotypes with data on DNA, RNA, and proteins obtained from peripheral blood using high-throughput methods, molecular disease characteristics can be correlated with clinical aspects of the infection, thus allowing the identification of fingerprints. The completion date is a rough estimate as the study will be completed after the documentation of the last follow-up visit of the last of approximately 300 patients. | This study aims for identifying transcriptome- and proteome-based signatures as well as bio-markers and genetic polymorphisms asso-ciated with community- or hospital-acquired pneumonia in CAP patients. Of particular interest are markers of the transition from uncomplicated pneumonia to severe pneumonia and pneumonia with an increased risk of sepsis. By linking well-defined clinical phenotypes with data on DNA, RNA, and proteins obtained from peripheral blood using high-throughput methods, molecular disease characteristics can be correlated with clinical aspects of the infection, thus allowing the identification of fingerprints. The completion date is a rough estimate as the study will be completed after the documentation of the last follow-up visit of the last of approximately 300 patients. | 20.08.24 | 31.12.27 | |||||
| 51.164 | Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate to severe ARDS - a randomised, placebo-controlled, double-blind trial Phase IIb, multicenter, randomized, placebo-controlled, double-blind, dose escalation study | Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate to severe ARDS - a randomised, placebo-controlled, double-blind trial Phase IIb, multicenter, randomized, placebo-controlled, double-blind, dose escalation study | PALI | Pneumonia and Acute Lung Injury | Associated Partner | Closed | NCT03567577 | 2017-003855-47 | NCT03567577, 2017-003855-47 | Interventional | DZL recruiting center | Externally - industry, Externally - public | Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a Phase I clinical trial. Here, we present the protocol for a Phase IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients. This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of 7 days, ensued by a follow-up period of an | Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a Phase I clinical trial. Here, we present the protocol for a Phase IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients. This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of 7 days, ensued by a follow-up period of an | 01.12.18 | 31.01.25 | ||
| 51.170 | SUPERNOVA: A Phase I/III Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AZD7518 for Pre-exposure Prophylaxis in Participants with Conditions Causing Immune Impairment | SUPERNOVA: A Phase I/III Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AZD7518 for Pre-exposure Prophylaxis in Participants with Conditions Causing Immune Impairment | ROR, DPLD | Patients with conditions causing immune impairment | CPC-M | Closed | 2022-002378-95 | 2022-002378-95 | Interventional | DZL recruiting center | Externally - industry | AZD7518, a combination of 2 novel mAbs AZD3959 and AZD3152, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for a pre-exposure prophylaxis of COVID-19 indication. | AZD7518, a combination of 2 novel mAbs AZD3959 and AZD3152, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for a pre-exposure prophylaxis of COVID-19 indication. | 08.01.23 | 14.01.24 | |||
| 51.190 | UNISUS: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parellel-group, Group-sequential, Adaptive, Event-driven Study to compare Efficiacy, Safety and Tolerability of Macitentan 75mg Versus Macitentan 10mg in Patients with Pulmonary Arterial Hypertension, Followed by an open-label Treatment Period with 75mg Macitentan | UNISUS: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parellel-group, Group-sequential, Adaptive, Event-driven Study to compare Efficiacy, Safety and Tolerability of Macitentan 75mg Versus Macitentan 10mg in Patients with Pulmonary Arterial Hypertension, Followed by an open-label Treatment Period with 75mg Macitentan | PH, DPLD | Patients with Pulmonary Arterial Hypertension (PAH) | CPC-M | Closed | 2019-002533-11 | 2019-002533-11 | Interventional | DZL recruiting center | Externally - industry | 04.10.22 | 31.12.24 | |||||
| 50.904 | A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1) | A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1) | LC | NSCLC and other solid tumors | ARCN, TLRC | Recruiting | NCT05384626 | 2022-000122-21 | NCT05384626, 2022-000122-21 | Interventional | DZL recruiting center | Externally - industry | Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors. | Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors. | 09.06.22 | 31.03.26 | ||
| 50.948 | A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (eVOLVE-Lung02) | A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (eVOLVE-Lung02) | LC | NSCLC | TLRC | Recruiting | NCT05984277 | 2023-503298-39-00 | NCT05984277, 2023-503298-39-00 | Interventional | DZL recruiting center | Externally - industry | The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%. | The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%. | 24.10.23 | 16.05.29 | ||
| 50.951 | A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC) | A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC) | LC | NSCLC | TLRC, BIH / Charité - Associated Partner | Recruiting | NCT06162221 | 2023-509571-16 | NCT06162221, 2023-509571-16 | Interventional | DZL recruiting center | Externally - industry | The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with each other | The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with each other | 18.01.24 | 31.12.28 | ||
| 50.959 | A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay | A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay | LC | NSCLC | BREATH | Active / not recruiting | 2024-511185-37-00 | 2024-511185-37-00 | Interventional | DZL recruiting center | Externally - industry | The primary objective of this study is to compare DFS in patients with completely resected (R0), stage I or IIA non-squamous NSCLC who are found to be at High or Intermediate Risk by the 14-Gene Prognostic Assay and who are subsequently either randomized to observation or randomized to and are willing to initiate adjuvant therapy with four cycles of a standard NSCLC platinum-based doublet (i.e., mITT population), so as to document the benefit of personalizing patient care based on molecular prognostic data. | The primary objective of this study is to compare DFS in patients with completely resected (R0), stage I or IIA non-squamous NSCLC who are found to be at High or Intermediate Risk by the 14-Gene Prognostic Assay and who are subsequently either randomized to observation or randomized to and are willing to initiate adjuvant therapy with four cycles of a standard NSCLC platinum-based doublet (i.e., mITT population), so as to document the benefit of personalizing patient care based on molecular prognostic data. | 26.02.24 | 10.02.25 | |||
| 50.993 | ADAURA-2 | ADAURA-2 | LC | NSCLC | CPC-M | Recruiting | NCT05120349 | 2023-509943-28 | NCT05120349, 2023-509943-28 | Interventional | DZL recruiting center | Externally - industry | A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection (ADAURA2) Osimertinib adjuvant vs. Placebo | A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection (ADAURA2) Osimertinib adjuvant vs. Placebo | 21.02.22 | 01.11.32 | ||
| 51.014 | ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC) | ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC) | CFBE | NTM | BREATH | Closed | 2020-002545-42 | 2020-002545-42 | Interventional | DZL recruiting center | Externally - industry | To generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints | To generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints | 23.03.21 | 04.11.22 | |||
| 51.028 | Brigatinib-5007 | Brigatinib-5007 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | Observational | DZL recruiting center | Externally - industry | A Cohort Study to Describe the Occurrence of Early-Onset Pulmonary Events in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Treated with Brigatinib: A Post-Authorisation Safety Study | A Cohort Study to Describe the Occurrence of Early-Onset Pulmonary Events in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Treated with Brigatinib: A Post-Authorisation Safety Study | 10.12.20 | 31.12.24 | |||||
| 51.043 | COSTAR Lung / 213410 | COSTAR Lung / 213410 | LC | NSCLC | CPC-M | Recruiting | NCT04655976 | 2023-507475-21-00 | NCT04655976, 2023-507475-21-00 | Interventional | DZL recruiting center | Externally - industry | Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants with Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy (Phase 2/3) | Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants with Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy (Phase 2/3) | 08.12.20 | 31.10.25 | ||
| 51.049 | CRISP / AIO-TRK-0315 | CRISP / AIO-TRK-0315 | LC | NSCLC | CPC-M | Recruiting | Interventional | DZL recruiting center | Externally - industry | Clinical Research Platform into Molecular Testing, Treatment, Outcome (CRISP): A Prospective German Registry in Stage IV NSCLC AIO-TRK-0315. | Clinical Research Platform into Molecular Testing, Treatment, Outcome (CRISP): A Prospective German Registry in Stage IV NSCLC AIO-TRK-0315. | 01.01.18 | 31.12.26 | |||||
| 51.066 | ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC) | ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC) | CFBE | NTM | BREATH | Active / not recruiting | 2020‐003079‐16 | 2020‐003079‐16 | Interventional | DZL recruiting center | Externally - industry | To evaluate the efficacy of ALIS + background regimen compared to the ELC + background regimen on patient-reported respiratory symptoms at Month 13 | To evaluate the efficacy of ALIS + background regimen compared to the ELC + background regimen on patient-reported respiratory symptoms at Month 13 | 23.03.21 | 31.12.25 | |||
| 51.077 | FINN (FIRST-LINE IPILIMUMAB + NIVOLUMAB COMBINED WITH TWO CYCLES OF CHEMOTHERAPY IN NSCLC) | FINN (FIRST-LINE IPILIMUMAB + NIVOLUMAB COMBINED WITH TWO CYCLES OF CHEMOTHERAPY IN NSCLC) | LC | NSCLC | BREATH | Active / not recruiting | Observational | DZL recruiting center | Externally - industry | The immune checkpoint inhibitor antibodies nivolumab and ipilimumab have distinct but complementary mechanisms of action. Several phase III and IV studies have assessed the activity and safety of dual checkpoint inhibitor blockade in first-line setting of advanced non-small cell lung cancer (NSCLC) patients. The randomized, open-label, phase III CheckMate 9LA trial demonstrated a statistically significant improvement in Overall Survival (OS), Progression-Free Survival (PFS) and Overall Response Rate (ORR) for patients treated with nivolumab plus ipilimumab and two cycles of chemotherapy compared to those who received chemotherapy alone. | The immune checkpoint inhibitor antibodies nivolumab and ipilimumab have distinct but complementary mechanisms of action. Several phase III and IV studies have assessed the activity and safety of dual checkpoint inhibitor blockade in first-line setting of advanced non-small cell lung cancer (NSCLC) patients. The randomized, open-label, phase III CheckMate 9LA trial demonstrated a statistically significant improvement in Overall Survival (OS), Progression-Free Survival (PFS) and Overall Response Rate (ORR) for patients treated with nivolumab plus ipilimumab and two cycles of chemotherapy compared to those who received chemotherapy alone. | 17.03.21 | 15.11.24 | |||||
| 51.103 | KEYVIBE-007 | KEYVIBE-007 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | NCT5226598 | 2023-506074-12 | NCT5226598, 2023-506074-12 | Interventional | DZL recruiting center | Externally - industry | "A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)" | "A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)" | 05.12.22 | 31.12.24 | ||
| 51.106 | Krascendo 1 | Krascendo 1 | LC | NSCLC | BIH / Charité - Associated Partner | Recruiting | 2024-510908-37-00 | 2024-510908-37-00 | Interventional | DZL recruiting center | Externally - industry | A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB VERSUS SOTORASIB OR ADAGRASIB IN PATIENTS WITH PREVIOUSLY TREATED KRAS G12C-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER | A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB VERSUS SOTORASIB OR ADAGRASIB IN PATIENTS WITH PREVIOUSLY TREATED KRAS G12C-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER | 19.11.24 | 31.12.29 | |||
| 51.108 | LIBRETTO-432 / J2G-MC-JZJX | LIBRETTO-432 / J2G-MC-JZJX | LC | NSCLC | TLRC, ARCN, CPC-M | Recruiting | NCT04819100 | 2023-506784-33-00 | NCT04819100, 2023-506784-33-00 | Interventional | DZL discovery-based | Externally - industry | LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC | LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC | 14.12.22 | 30.08.32 | ||
| 51.129 | NivoPass / CA209-234 NIS | NivoPass / CA209-234 NIS | LC | NSCLC, SCLC | CPC-M | Closed | NCT02847728 | NCT02847728 | Interventional | DZL recruiting center | Externally - industry | Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice | Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice | 28.07.16 | 31.03.24 | |||
| 51.133 | OCTOPUS / NIS12500 | OCTOPUS / NIS12500 | LC | NSCLC | CPC-M | Closed | NCT05546905 | NCT05546905 | Interventional | DZL recruiting center | Externally - industry | An ambispective observational study describing diagnosis and treatment patterns in adults with metastatic non-small cell lung cancer with BRAF V600E mutation in clinical practice, to assess treatment effectiveness and quality of life - OCTOPUS | An ambispective observational study describing diagnosis and treatment patterns in adults with metastatic non-small cell lung cancer with BRAF V600E mutation in clinical practice, to assess treatment effectiveness and quality of life - OCTOPUS | 31.12.22 | 31.12.24 | |||
| 51.137 | PACIFIC-R | PACIFIC-R | LC | NSCLC | CPC-M | Closed | NCT03798535 | NCT03798535 | Interventional | DZL recruiting center | Externally - industry | First real-world data on unresectable stage III NSCLC patients treated with Durvalumab after chemoradiotherapy | First real-world data on unresectable stage III NSCLC patients treated with Durvalumab after chemoradiotherapy | 19.12.18 | 16.07.24 | |||
| 51.155 | Real-World Study of Early-Stage NSCLC | Real-World Study of Early-Stage NSCLC | LC | NSCLC | CPC-M | Closed | NCT04742192 | NCT04742192 | Interventional | DZL recruiting center | Externally - industry | Real-World Study of Early-Stage NSCLC: Prevalence of EGFR Mutations, Treatment, and Outcomes | Real-World Study of Early-Stage NSCLC: Prevalence of EGFR Mutations, Treatment, and Outcomes | 04.03.21 | 30.11.22 | |||
| 51.167 | Second line therapy with Vargatef in advanced lung adenocarcinoma patients | Second line therapy with Vargatef in advanced lung adenocarcinoma patients | LC | NSCLC | CPC-M | Recruiting | NCT02392455 | NCT02392455 | Interventional | DZL recruiting center | Externally - industry | Second line therapy with Vargatef in advanced lung adenocarcinoma patients | Second line therapy with Vargatef in advanced lung adenocarcinoma patients | 23.03.15 | 31.01.25 | |||
| 51.186 | TroFuse-023 | TroFuse-023 | LC | NSCLC | BIH / Charité - Associated Partner | Recruiting | 2023-510128-66 | 2023-510128-66 | Interventional | DZL recruiting center | Externally - industry | A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer | A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer | 28.11.24 | 31.12.29 | |||
| 50.907 | A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor" | A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor" | LC | NSCLC | BREATH | Active / not recruiting | 2021-001928-17 | 2021-001928-17 | Interventional | DZL recruiting center | Externally - industry | Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLC | Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLC | 19.01.23 | 31.12.25 | |||
| 50.909 | A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non Small Cell Lung Cancer | A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non Small Cell Lung Cancer | LC | NSCLC | ARCN, TLRC | Recruiting | NCT05565378 | 2021-005115-32 | NCT05565378, 2021-005115-32 | Interventional | DZL recruiting center | Externally - industry | This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] >= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug. | This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] >= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug. | 14.10.22 | 02.10.28 | ||
| 50.937 | A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (HORIZON 1 (BO42777)) | A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (HORIZON 1 (BO42777)) | LC | NSCLC | CPC-M, TLRC | Recruiting | NCT05170204 | 2023-503920-14-00 | NCT05170204, 2023-503920-14-00 | Interventional | DZL recruiting center | Externally - industry | A phase I-III multicenter study evaluating the efficacy and safety of multiple therapies in cohorts of patients selected according to biomarker status, with locally advanced, unresectable, stage III non-small cell lung cancer (ALK positive, ROS1 positive, RET fusion positive; TEST PRODUCTS: Alectinib (RO5424802), Entrectinib (RO7102122), Pralsetinib (RO7499790)). This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system. | A phase I-III multicenter study evaluating the efficacy and safety of multiple therapies in cohorts of patients selected according to biomarker status, with locally advanced, unresectable, stage III non-small cell lung cancer (ALK positive, ROS1 positive, RET fusion positive; TEST PRODUCTS: Alectinib (RO5424802), Entrectinib (RO7102122), Pralsetinib (RO7499790)). This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system. | 01.11.22 | 01.09.33 | ||
| 50.976 | A Randomized, Phase 3, Open-label Study to Evaluate SGN-B6A Compared With Docetaxel in Adult Subjects With Previously Treated Non-small Cell Lung Cancer (SEAGEN BE6A LUNG-01 (SGNB6A-002)) | A Randomized, Phase 3, Open-label Study to Evaluate SGN-B6A Compared With Docetaxel in Adult Subjects With Previously Treated Non-small Cell Lung Cancer (SEAGEN BE6A LUNG-01 (SGNB6A-002)) | LC | NSCLC | ARCN, TLRC | Recruiting | NCT06012435 | 2023-503827-25-00 | NCT06012435, 2023-503827-25-00 | Interventional | DZL recruiting center | Externally - industry | This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease. | This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease. | 21.02.24 | 31.07.28 | ||
| 51.012 | ANTELOPE | ANTELOPE | LC | NSCLC | CPC-M, BIH / Charité - Associated Partner | Recruiting | NCT05689671 | 2023-505054-17-00 | NCT05689671, 2023-505054-17-00 | Interventional | DZL Investigator Initiated Trial, DZL recruiting center | Externally - industry | "ANTELOPE – Atezolizumab/Carboplatin/nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in metastatic TTF-1 negative lung adenocarcinoma" | "ANTELOPE – Atezolizumab/Carboplatin/nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in metastatic TTF-1 negative lung adenocarcinoma" | 05.12.23 | 31.12.27 | ||
| 51.020 | Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations | Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations | LC | NSCLC | TLRC | Recruiting | NCT06151574 | 2023-504308-27-00 | NCT06151574, 2023-504308-27-00 | Interventional | DZL recruiting center | Externally - industry | This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life. | This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life. | 09.02.24 | 25.01.27 | ||
| 51.029 | BX43361 (master screening study) | BX43361 (master screening study) | LC | NSCLC | CPC-M | Recruiting | NCT05419375 | 2021-004401-53 | NCT05419375, 2021-004401-53 | Interventional | DZL recruiting center | Externally - industry | Master screening study to determine biomarker status and potential trial eligibility for patients with malignant tumors | Master screening study to determine biomarker status and potential trial eligibility for patients with malignant tumors | 22.07.22 | 22.12.32 | ||
| 51.036 | CheckMate 77T | CheckMate 77T | LC | NSCLC | BIH / Charité - Associated Partner | Closed | NCT04025879 | 2022-502658-15 | NCT04025879, 2022-502658-15 | Interventional | DZL recruiting center | Externally - industry | A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer | A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer | 17.09.20 | 31.12.27 | ||
| 51.040 | CodeBreaK 202 / 20190341 | CodeBreaK 202 / 20190341 | LC | NSCLC | CPC-M | Recruiting | NCT05920356 | 2022-501863-41 | NCT05920356, 2022-501863-41 | Interventional | DZL recruiting center | Externally - industry | A Phase 3 Study of Front-Line Platinum Doublet Therapy With Sotorasib Versus Pembrolizumab in PD-L1 Negative KRAS p.G12C Positive Advanced/Metastatic NSCLC (CodeBreaK 202) | A Phase 3 Study of Front-Line Platinum Doublet Therapy With Sotorasib Versus Pembrolizumab in PD-L1 Negative KRAS p.G12C Positive Advanced/Metastatic NSCLC (CodeBreaK 202) | 16.11.23 | 01.03.31 | ||
| 51.098 | KEYLINK-012 | KEYLINK-012 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | 2023-503591-25 | 2023-503591-25 | Interventional | DZL recruiting center | Externally - industry | "A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)" | "A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)" | 04.11.20 | 31.12.27 | |||
| 51.101 | KEYNOTE-867 | KEYNOTE-867 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | NCT04380636 | 2022-500413-11-00 | NCT04380636, 2022-500413-11-00 | Interventional | DZL recruiting center | Externally - industry | A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK 3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867) | A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK 3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867) | 17.08.22 | 31.10.24 | ||
| 51.102 | KEYVIBE-006 | KEYVIBE-006 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | NCT05298423 | 2022-502752-31-00 | NCT05298423, 2022-502752-31-00 | Interventional | DZL recruiting center | Externally - industry | "Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK- 7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC (KEYVIBE-006)" | "Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK- 7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC (KEYVIBE-006)" | 22.04.22 | 31.12.27 | ||
| 51.114 | MARIPOSA-2 / 61186372NSC3002 | MARIPOSA-2 / 61186372NSC3002 | LC | NSCLC | CPC-M | Closed | NCT04988295 | 2021-001825-33 | NCT04988295, 2021-001825-33 | Interventional | DZL recruiting center | Externally - industry | A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure | A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure | 17.11.21 | 30.06.26 | ||
| 51.165 | SAFFRON | SAFFRON | LC | NSCLC | BIH / Charité - Associated Partner | Recruiting | 2023-504158-36 | 2023-504158-36 | Interventional | DZL recruiting center | Externally - industry | "A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON)" | "A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON)" | 10.10.23 | 31.12.29 | |||
| 51.185 | TroFuse-007: A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50% | TroFuse-007: A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50% | LC | NSCLC | BIH / Charité - Associated Partner, BREATH | Recruiting | 2023-503376-24 | 2023-503376-24 | Interventional | DZL recruiting center | Externally - industry | A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50%. To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to OS | A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50%. To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to OS | 01.10.24 | 31.12.29 | |||
| 51.188 | TROPION-Lung07 / DS1062-A-U303 | TROPION-Lung07 / DS1062-A-U303 | LC | NSCLC | CPC-M | Recruiting | NCT05555732 | 2022-500802-16-00 | NCT05555732, 2022-500802-16-00 | Interventional | DZL recruiting center | Externally - industry | A randomized phase 3 study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or without platinum chemotherapy, in subjects with no prior therapy for advanced or metastatic PD-L1 TPS <50% non-squamous non-small cell lung cancer without actionable genomic alterations (TROPION-Lung07) | A randomized phase 3 study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or without platinum chemotherapy, in subjects with no prior therapy for advanced or metastatic PD-L1 TPS | 11.01.23 | 01.08.27 | ||
| 51.189 | TROPION-Lung08 / DS1062-A-U304 | TROPION-Lung08 / DS1062-A-U304 | LC | NSCLC | CPC-M | Recruiting | NCT05215340 | 2021-002555-10 | NCT05215340, 2021-002555-10 | Interventional | DZL discovery-based | Externally - industry | A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08) | A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08) | 04.03.22 | 30.04.28 | ||
| 51.376 | Neoadjuvant TiRagolumab, Atezolizumab and Chemotherapy - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing: a Non-randomized, Open-label, Single-arm Phase II Study (IKF NEOTRACK) | Neoadjuvant TiRagolumab, Atezolizumab and Chemotherapy - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing: a Non-randomized, Open-label, Single-arm Phase II Study (IKF NEOTRACK) | LC | NSCLC | TLRC | Recruiting | NCT05825625 | 2022-501322-38-00 | NCT05825625, 2022-501322-38-00 | Interventional | DZL Investigator Initiated Trial | Externally - industry | Prospective, non-randomized, open-label, single-arm phase II trial to investigate the feasibility and efficacy of combining chemotherapy with tiragolumab and atezolizumab as neoadjuvant and adjuvant treatment for surgical NSCLC patients. | Prospective, non-randomized, open-label, single-arm phase II trial to investigate the feasibility and efficacy of combining chemotherapy with tiragolumab and atezolizumab as neoadjuvant and adjuvant treatment for surgical NSCLC patients. | 26.05.23 | 01.02.30 | ||
| 51.377 | A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation (WU-KONG28) | A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation (WU-KONG28) | LC | NSCLC | TLRC | Recruiting | NCT05668988 | 2022-502959-54-00 | NCT05668988, 2022-502959-54-00 | Interventional | DZL recruiting center | Externally - industry | This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without). | This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without). | 13.12.22 | 31.10.27 | ||
| 51.378 | A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib (COCOON) | A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib (COCOON) | LC | NSCLC | UGMLC, TLRC | Recruiting | NCT06120140 | 2023-505863-35-00 | NCT06120140, 2023-505863-35-00 | Interventional | DZL recruiting center | Externally - industry | The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib. | The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib. | 16.02.24 | 31.03.26 | ||
| 50.933 | A phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing Niraparib plus Pembrolizumab vs placebo plus Pembrolizumab as maintenance therapy in participants whose disease has remained stable or responded to first-line platinum-based chemotherapy with Pembrolizumab for stage IIIB/IIIC or IV non-small cell lung cancer (ZEAL-1L) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing Niraparib plus Pembrolizumab vs placebo plus Pembrolizumab as maintenance therapy in participants whose disease has remained stable or responded to first-line platinum-based chemotherapy with Pembrolizumab for stage IIIB/IIIC or IV non-small cell lung cancer (ZEAL-1L) | LC | NSCLC | CPC-M | Recruiting | NCT04475939 | 2020-002202-20 | NCT04475939, 2020-002202-20 | Interventional | DZL recruiting center | Externally - industry | A phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing Niraparib plus Pembrolizumab vs placebo plus Pembrolizumab as maintenance therapy in participants whose disease has remained stable or responded to first-line platinum-based chemotherapy with Pembrolizumab for stage IIIB/IIIC or IV non-small cell lung cancer (ZEAL-1L) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing Niraparib plus Pembrolizumab vs placebo plus Pembrolizumab as maintenance therapy in participants whose disease has remained stable or responded to first-line platinum-based chemotherapy with Pembrolizumab for stage IIIB/IIIC or IV non-small cell lung cancer (ZEAL-1L) | 26.10.20 | 19.02.25 | ||
| 50.946 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with EGFRm, Locally Advanced or Metastatic NSCLC who have Progressed Extracranially following First-Line Osimertinib Therapy (COMPEL) | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with EGFRm, Locally Advanced or Metastatic NSCLC who have Progressed Extracranially following First-Line Osimertinib Therapy (COMPEL) | LC | NSCLC | BREATH, CPC-M | Active / not recruiting | NCT04765059 | 2019-003969-18 | NCT04765059, 2019-003969-18 | Interventional | DZL recruiting center | Externally - industry | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with EGFRm, Locally Advanced or Metastatic NSCLC who have Progressed Extracranially following First-Line Osimertinib Therapy (COMPEL) To compare the efficacy of chemotherapy plus osimertinib treatment relative to chemotherapy plus placebo based on PFS | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with EGFRm, Locally Advanced or Metastatic NSCLC who have Progressed Extracranially following First-Line Osimertinib Therapy (COMPEL) To compare the efficacy of chemotherapy plus osimertinib treatment relative to chemotherapy plus placebo based on PFS | 12.09.21 | 31.12.25 | ||
| 50.991 | ABP | ABP | LC | NSCLC | CPC-M, BIH / Charité - Associated Partner | Active, but not recruiting | NCT04318938 | 2019-001828-36 | NCT04318938, 2019-001828-36 | Interventional | DZL recruiting center | Externally - industry | Advancing Brigatinib Properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients by deep phenotyping | Advancing Brigatinib Properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients by deep phenotyping | 30.03.20 | 31.12.27 | ||
| 50.992 | AcceleRET Lung | AcceleRET Lung | LC | NSCLC | CPC-M | Closed | 2019-002463-10 | 2019-002463-10 | Interventional | DZL recruiting center | Externally - industry | AcceleRET Lung: A phase III study of first-line pralsetinib in patients (pts) with RET-fusion+ advanced/metastatic non-small cell lung cancer (NSCLC). | AcceleRET Lung: A phase III study of first-line pralsetinib in patients (pts) with RET-fusion+ advanced/metastatic non-small cell lung cancer (NSCLC). | 24.07.20 | 23.01.24 | |||
| 50.996 | AFAMOSI | AFAMOSI | LC | NSCLC | CPC-M | Closed | NCT04413201 | 2019-002197-31 | NCT04413201, 2019-002197-31 | Interventional | DZL recruiting center | Externally - industry | Afatinib followed by Osimertinib compared to Osimertinib in patients with EGFR mutated/T790M negative NSCLC in firstline | Afatinib followed by Osimertinib compared to Osimertinib in patients with EGFR mutated/T790M negative NSCLC in firstline | 11.09.20 | 30.06.24 | ||
| 51.004 | AMG510 | AMG510 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | 2019‐003582‐18 | 2019‐003582‐18 | Interventional | DZL recruiting center | Externally - industry | "A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C" | "A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C" | 01.09.19 | 30.06.21 | |||
| 51.027 | Break B5-BM-NSCLC | Break B5-BM-NSCLC | LC | NSCLC | CPC-M | Recruiting | 2020-000693-18 | 2020-000693-18 | Interventional | DZL recruiting center | Externally - industry | Breaking the big Five Barriers of Brain Metastasis, (Break B5-BM NSCLC Trial): A prospective phase II, open-label, multi-center trial of combined nivolumab, ipilimumab and bevacizumab together with 2 cycles of induction chemotherapy in patients with non-squamous nonsmall-cell lung cancer (NSCLC) metastatic to the brain | Breaking the big Five Barriers of Brain Metastasis, (Break B5-BM NSCLC Trial): A prospective phase II, open-label, multi-center trial of combined nivolumab, ipilimumab and bevacizumab together with 2 cycles of induction chemotherapy in patients with non-squamous nonsmall-cell lung cancer (NSCLC) metastatic to the brain | 14.04.21 | 31.12.25 | |||
| 51.031 | Canopy 1 / CACZ885U2301 | Canopy 1 / CACZ885U2301 | LC | NSCLC | CPC-M | Closed | NCT03631199 | 2018-001547-32 | NCT03631199, 2018-001547-32 | Interventional | DZL recruiting center | Externally - industry | Efficacy and safety of Pembrolizumab plus platinum-based chemotherapy with or without Canakinumab as first line therapy for locally advanced or metastatic NSCLC. Phase III, Randomized, double blind, placebo controlled | Efficacy and safety of Pembrolizumab plus platinum-based chemotherapy with or without Canakinumab as first line therapy for locally advanced or metastatic NSCLC. Phase III, Randomized, double blind, placebo controlled | 21.12.18 | 07.06.27 | ||
| 51.053 | DESTINY-Lung04 / D967SC00001 | DESTINY-Lung04 / D967SC00001 | LC | NSCLC | CPC-M | Recruiting | NCT05048797 | 2021-000634-33 | NCT05048797, 2021-000634-33 | Interventional | DZL recruiting center | Externally - industry | An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04) | An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04) | 18.10.21 | 29.03.27 | ||
| 51.100 | KEYNOTE-799 | KEYNOTE-799 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | 2018-000714-37 | 2018-000714-37 | Interventional | DZL recruiting center | Externally - industry | A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799) | A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799) | 25.10.18 | 06.06.24 | |||
| 51.118 | MK-7339-006 | MK-7339-006 | LC | NSCLC | CPC-M | Closed | NCT03976323 | 2018-004720-11 | NCT03976323, 2018-004720-11 | Interventional | DZL recruiting center | Externally - industry | A phase III Study, Pembrolizumab in Combination with Pemetrexed/Platinum followed by Pembrolizumab and maintenance Olaparib vs. Maintenance Pemetrexed in firstline treatment of NSCLC non-squamous | A phase III Study, Pembrolizumab in Combination with Pemetrexed/Platinum followed by Pembrolizumab and maintenance Olaparib vs. Maintenance Pemetrexed in firstline treatment of NSCLC non-squamous | 28.06.19 | 13.01.25 | ||
| 51.119 | MK-7339-008 | MK-7339-008 | LC | NSCLC | CPC-M | Recruiting | NCT03976362 | 2018-004721-88 | NCT03976362, 2018-004721-88 | Interventional | DZL recruiting center | Externally - industry | A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) | A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) | 28.06.19 | 12.03.25 | ||
| 51.136 | PACE-LUNG | PACE-LUNG | LC | NSCLC | CPC-M, BIH / Charité - Associated Partner | Recruiting | NCT05281406 | 2019-004757-88 | NCT05281406, 2019-004757-88 | Interventional | DZL recruiting center | Externally - public | Additional chemotherapy for EGFRm patients with the continued presence of plasma ctDNA EGFRm at week 3 after start of osimertinib 1st-line treatment | Additional chemotherapy for EGFRm patients with the continued presence of plasma ctDNA EGFRm at week 3 after start of osimertinib 1st-line treatment | 12.11.21 | 31.12.27 | ||
| 51.163 | ROSE | ROSE | LC | NSCLC | CPC-M, TLRC, BIH / Charité - Associated Partner | Recruiting | NCT05089916 | 2020-003512-27 | NCT05089916, 2020-003512-27 | Interventional | DZL Investigator Initiated Trial, DZL recruiting center | Externally - public | Radiation during Osimertinib Treatment: a Safety and Efficacy Cohort Study | Radiation during Osimertinib Treatment: a Safety and Efficacy Cohort Study | 20.01.22 | 31.12.27 | ||
| 51.171 | TAK-788-3001 | TAK-788-3001 | LC | NSCLC | CPC-M | Closed | NCT04129502 | 2019-001845-42 | NCT04129502, 2019-001845-42 | Interventional | DZL recruiting center | Externally - industry | A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations | A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations | 10.01.20 | 31.07.25 | ||
| 51.174 | TeliMET NSCLC-01 | TeliMET NSCLC-01 | LC | NSCLC | BIH / Charité - Associated Partner | Recruiting | 2021-001811-94 | 2021-001811-94 | Interventional | DZL recruiting center | Externally - industry | "A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer" | "A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer" | 16.01.24 | 31.12.27 | |||
| 51.178 | Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy - Employing Optimized (Hypofractionated) Radiotherapy to Foster Durvalumab Efficacy (IKF TRADE-HYPO) | Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy - Employing Optimized (Hypofractionated) Radiotherapy to Foster Durvalumab Efficacy (IKF TRADE-HYPO) | LC | NSCLC | BREATH, TLRC | Recruiting | NCT04351256 | 2019-002192-33 | NCT04351256, 2019-002192-33 | Interventional | DZL recruiting center | Externally - public, Externally - industry | This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty). Toxizität, definiert durch das Auftreten von behandlungsbedingter Pneumonitis Grad ≥3 Objektives Ansprechen nach RECIST 1.1 Kriterien | This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty). Toxizität, definiert durch das Auftreten von behandlungsbedingter Pneumonitis Grad ≥3 Objektives Ansprechen nach RECIST 1.1 Kriterien | 20.05.20 | 30.06.26 | ||
| 51.182 | TREASURE - Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease: a randomized, open-label, multicenter phase II study | TREASURE - Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease: a randomized, open-label, multicenter phase II study | LC | NSCLC | BREATH, CPC-M | Closed | NCT04462276 | 2019-003916-29 | NCT04462276, 2019-003916-29 | Interventional | DZL recruiting center | Externally - public | Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease: a randomized, open-label, multicenter phase II study | Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease: a randomized, open-label, multicenter phase II study | 28.07.20 | 31.08.24 | ||
| 51.187 | TROPION Lung01 | TROPION Lung01 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | 2020-004643-80 | 2020-004643-80 | Interventional | DZL recruiting center | Externally - industry | PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS DOCETAXEL IN PREVIOUSLY TREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITHOUT ACTIONABLE GENOMIC ALTERATIONS (TROPION-LUNG01) | PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS DOCETAXEL IN PREVIOUSLY TREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITHOUT ACTIONABLE GENOMIC ALTERATIONS (TROPION-LUNG01) | 01.04.22 | 31.12.22 | |||
| 51.375 | Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients: Defining Optimal Combinations and Determinants of Immunological Response (UKE NEOPREDICT LUNG) | Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients: Defining Optimal Combinations and Determinants of Immunological Response (UKE NEOPREDICT LUNG) | LC | NSCLC | TLRC | Recruiting | NCT04205552 | 2019-002478-29 | NCT04205552, 2019-002478-29 | Interventional | DZL recruiting center | Externally - public, Externally - industry | The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection. | The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection. | 04.03.20 | 30.06.25 | ||
| 50.900 | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) | CFBE | Non-Cystic Fibrosis Bronchiectasis | BREATH, CPC-M | Closed | NCT05006573 | 2020-004068-24 | NCT05006573, 2020-004068-24 | Interventional | DZL discovery-based | Externally - industry | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis; To evaluate the effect of benralizumab 30 mg Q4W on bronchiectasis exacerbations | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis; To evaluate the effect of benralizumab 30 mg Q4W on bronchiectasis exacerbations | 05.07.21 | 31.12.25 | ||
| 50.958 | A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf™) (Boehringer_1397- 0012) | A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf™) (Boehringer_1397- 0012) | CFBE | Non-Cystic Fibrosis Bronchiectasis | BIH / Charité - Associated Partner, ARCN, CPC-M | Closed | NCT05238675 | 2021-003304-41 | NCT05238675, 2021-003304-41 | Interventional | DZL recruiting center, DZL on steering board, DZL Investigator Initiated Trial | Externally - industry | The primary objective of the study is to demonstrate a non-flat dose response curve and evaluate the dose-response relationship for 3 oral dosing regimens of BI 1291583 versus placebo on the primary endpoint, the time to first pulmonary exacerbation up to week 48. | The primary objective of the study is to demonstrate a non-flat dose response curve and evaluate the dose-response relationship for 3 oral dosing regimens of BI 1291583 versus placebo on the primary endpoint, the time to first pulmonary exacerbation up to week 48. | 28.11.22 | 30.05.24 | ||
| 51.015 | ASPEN: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of INS1007 Administered Once Daily for 52 Weeks in Subjectswith Non-Cystic Fibrosis; A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis | ASPEN: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of INS1007 Administered Once Daily for 52 Weeks in Subjectswith Non-Cystic Fibrosis; A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis | CFBE | Non-Cystic Fibrosis Bronchiectasis | BREATH, CPC-M, TLRC, UGMLC, BIH / Charité - Associated Partner | Closed | NCT04594369 | 2020-003688-25 | NCT04594369, 2020-003688-25 | Interventional | DZL Investigator Initiated Trial, DZL recruiting center | Externally - industry | The primary estimand for efficacy endpoints is the On-Study estimand. The treatment regimen in the On-Study estimand will be the randomized IP (ie, study treatment) plus standard of care taken up to 52 weeks irrespective of whether a new chronic antibiotic is added during the treatment period for prevention of future PE. The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period. | The primary estimand for efficacy endpoints is the On-Study estimand. The treatment regimen in the On-Study estimand will be the randomized IP (ie, study treatment) plus standard of care taken up to 52 weeks irrespective of whether a new chronic antibiotic is added during the treatment period for prevention of future PE. The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period. | 08.04.21 | 27.08.24 | ||
| 51.017 | Attention to Infants at Respiratory Risks (AIRR study) | Attention to Infants at Respiratory Risks (AIRR study) | DPLD | neonatal Chronic Lung Disease (nCLD) or Bronchopulmonary Dysplasia (BPD) | CPC-M, UGMLC | Recruiting | Observational | DZL recruiting center | Externally - public | Bronchopulmonary dysplasia (BPD) is a chronic pulmonary disorder affecting more than 30% of all very preterm infants that increases the risk for pulmonary and neurologic sequelae persisting into adulthood. While mechanical ventilation (MV) and oxygen therapy offer life saving treatment to this patient population, they mainly contribute to the development of this disease. A profound understanding of the molecular mechanisms regulating the characteristically impaired alveolar and vascular development still remains elusive and early markers that allow the prediction of BPD development and the progression of this disease in the preterm infant are urgently needed. The overall aim of the proposed project is to shed light into the molecular mechanisms underlying BPD and to identify biomarkers that allow for the early diagnosis of the disease. | Bronchopulmonary dysplasia (BPD) is a chronic pulmonary disorder affecting more than 30% of all very preterm infants that increases the risk for pulmonary and neurologic sequelae persisting into adulthood. While mechanical ventilation (MV) and oxygen therapy offer life saving treatment to this patient population, they mainly contribute to the development of this disease. A profound understanding of the molecular mechanisms regulating the characteristically impaired alveolar and vascular development still remains elusive and early markers that allow the prediction of BPD development and the progression of this disease in the preterm infant are urgently needed. The overall aim of the proposed project is to shed light into the molecular mechanisms underlying BPD and to identify biomarkers that allow for the early diagnosis of the disease. | 28.01.13 | 31.12.30 | |||||
| 51.032 | Canopy A / CACZ885T2301 | Canopy A / CACZ885T2301 | LC | NSCLC | CPC-M | Closed | NCT03447769 | 2017-004011-39 | NCT03447769, 2017-004011-39 | Interventional | DZL recruiting center | Externally - industry | A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC) | A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC) | 16.03.18 | 07.02.23 | ||
| 51.055 | EC-120888 | EC-120888 | LC | NSCLC | CPC-M | Recruiting | 2013-001494-24 | 2013-001494-24 | Interventional | DZL recruiting center | Externally - industry | A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay | A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay | 03.11.20 | 31.12.26 | |||
| 51.068 | ERADICATE - Inhaled ColiFin® in adult bronchiectasis patients with early asymptomatic Pseudomonas aeruginosa infection – an open-label, proof of concept – randomized controlled trial | ERADICATE - Inhaled ColiFin® in adult bronchiectasis patients with early asymptomatic Pseudomonas aeruginosa infection – an open-label, proof of concept – randomized controlled trial | CFBE | Non-Cystic Fibrosis Bronchiectasis | BREATH, UGMLC, CPC-M, BIH / Charité - Associated Partner | Recruiting | 2021-002335-33, 2023-509277-22 | DRKS00028518 | 2021-002335-33, 2023-509277-22, DRKS00028518 | Interventional | DZL recruiting center, DZL Investigator Initiated Trial, DZL on steering board | DZL, Externally - industry | Patients with bronchiectasis disease and a chronic infection with the bacterium Pseudomonas aeruginosa in the lungs have more symptoms and a poorer quality of life than patients whose lungs are not infected with this pathogen. If Pseudomonas aeruginosa is detected in the sputum for the first time, antibiotic therapy is therefore often administered. Whether such antibiotic therapy can eliminate (“eradicate”) the pathogen from the lungs has not been sufficiently investigated scientifically. This study therefore examines patients in whom Pseudomonas aeruginosa is detected in the sputum for the first time. Treatment with the inhaled antibiotic colistin in addition to the existing standard therapy will be investigated for 4 weeks. Both groups will then be regularly monitored for 6 months. The aim of the study is to find out whether such a therapy can eliminate Pseudomonas aeruginosa from the lungs or whether there are certain reasons that favor a permanent infection with this germ. The trial is designed to evaluate the efficacy of inhaled ColiFin® in adult bronchiectasis patients with asymptomatic Pseudomonas aeruginosa (PA) infection. Primary endpoint for efficacy assessment is the proportion of patients with ‘successful’ (i.e. three or more subsequent tests for sputum/airway cultures having consistently negative have results) PA eradication 28 weeks after randomization. For evaluation of superiority, the null hypothesis of a success rate being equal or less in the ColiFin® group when compared to the control group will be tested by means of a one tailed chi square test given a onesided significance level of 2.5 %. | Patients with bronchiectasis disease and a chronic infection with the bacterium Pseudomonas aeruginosa in the lungs have more symptoms and a poorer quality of life than patients whose lungs are not infected with this pathogen. If Pseudomonas aeruginosa is detected in the sputum for the first time, antibiotic therapy is therefore often administered. Whether such antibiotic therapy can eliminate (“eradicate”) the pathogen from the lungs has not been sufficiently investigated scientifically. This study therefore examines patients in whom Pseudomonas aeruginosa is detected in the sputum for the first time. Treatment with the inhaled antibiotic colistin in addition to the existing standard therapy will be investigated for 4 weeks. Both groups will then be regularly monitored for 6 months. The aim of the study is to find out whether such a therapy can eliminate Pseudomonas aeruginosa from the lungs or whether there are certain reasons that favor a permanent infection with this germ. The trial is designed to evaluate the efficacy of inhaled ColiFin® in adult bronchiectasis patients with asymptomatic Pseudomonas aeruginosa (PA) infection. Primary endpoint for efficacy assessment is the proportion of patients with ‘successful’ (i.e. three or more subsequent tests for sputum/airway cultures having consistently negative have results) PA eradication 28 weeks after randomization. For evaluation of superiority, the null hypothesis of a success rate being equal or less in the ColiFin® group when compared to the control group will be tested by means of a one tailed chi square test given a onesided significance level of 2.5 %. | 29.06.22 | 31.12.25 | ||
| 51.074 | eXALT3 | eXALT3 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | 2015-004147-40 | 2015-004147-40 | Interventional | DZL recruiting center | Externally - industry | Phase 3 Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients | Phase 3 Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients | 01.02.17 | 22.05.24 | |||
| 51.085 | HANSE (Holistic implementation study Assessing a Northern German interdisciplinary lung cancer Screening Effort) | HANSE (Holistic implementation study Assessing a Northern German interdisciplinary lung cancer Screening Effort) | PLI, LC | Lung cancer | BREATH | Closed | NCT04913155 | NCT04913155 | Observational | DZL discovery-based, DZL recruiting center | DZL, Externally - industry | The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated in the current infrastructure of certified lung cancer centers. | The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated in the current infrastructure of certified lung cancer centers. | 23.07.21 | 30.11.23 | |||
| 51.092 | International documentation on the use of Cytotect CP® Biotest for patients after lung and heart transplantation | International documentation on the use of Cytotect CP® Biotest for patients after lung and heart transplantation | ROR | Lung Transplantation | BREATH | Recruiting | Observational | DZL recruiting center | Externally - industry | Prospective documentation of the real-world usage of Cytotect for prophylaxis, pre-emptive treatment and treatment of CMV infection after heart transplantation (HT) and lung transplantation (LT). | Prospective documentation of the real-world usage of Cytotect for prophylaxis, pre-emptive treatment and treatment of CMV infection after heart transplantation (HT) and lung transplantation (LT). | 28.12.22 | 04.02.25 | |||||
| 51.093 | International Multicenter Registry on Extracorporal Life Support (ECLS) and Lung Transplantation | International Multicenter Registry on Extracorporal Life Support (ECLS) and Lung Transplantation | ROR | Lung Transplantation | BREATH | Recruiting | Observational | DZL recruiting center | Externally - public | Data collection in a multicenter registry to determine whether the choice of ECLS (ECMO vs CPB) versus OPLTx during lung transplantation affects outcomes. | Data collection in a multicenter registry to determine whether the choice of ECLS (ECMO vs CPB) versus OPLTx during lung transplantation affects outcomes. | 30.05.18 | 04.02.25 | |||||
| 51.099 | KEYNOTE-091 | KEYNOTE-091 | LC | NSCLC | BIH / Charité - Associated Partner | Closed | NCT02504372 | 2015-000575-27 | NCT02504372, 2015-000575-27 | Interventional | DZL recruiting center | Externally - industry | A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS) KEYNOTE-091 | A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS) KEYNOTE-091 | 07.12.17 | 31.12.27 | ||
| 51.105 | KORA | KORA | COPD | Lung Function | CPC-M | Recruiting | Observational | DZL discovery-based | Externally - public | Population-based cohort from the Augsburg region | Population-based cohort from the Augsburg region | 01.10.06 | 20.12.24 | |||||
| 51.121 | Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation | Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation | ROR | Lung Transplantation | BREATH | Recruiting | NCT03798860 | NCT03798860 | Observational | DZL Investigator Initiated Trial | Externally - industry | This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation. | This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation. | 31.08.18 | 04.02.25 | |||
| 51.125 | NAKO | NAKO | COPD | Lung function and respiratory status | CPC-M | Recruiting | Observational | DZL discovery-based | Externally - public | Population-based prospective cohort study | Population-based prospective cohort study | 01.03.14 | 20.12.24 | |||||
| 51.132 | Observational Study on the Clinical Use of Ex Vivo Lung Perfusion (XPS™) for Lung Transplantation | Observational Study on the Clinical Use of Ex Vivo Lung Perfusion (XPS™) for Lung Transplantation | ROR | Lung Transplantation | BREATH | Recruiting | NCT06795516 | NCT06795516 | Observational | DZL Investigator Initiated Trial | Externally - public | Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis. | Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis. | 31.01.25 | 04.02.25 | |||
| 51.151 | Pulmonary Embolism International THrOmbolysis trial: A reduced dose of thrombolytic treatment for patients with intermediatehigh- risk acute pulmonary embolism: a randomized, placebo-controlled trial" | Pulmonary Embolism International THrOmbolysis trial: A reduced dose of thrombolytic treatment for patients with intermediatehigh- risk acute pulmonary embolism: a randomized, placebo-controlled trial" | PALI | Lungenembolie | BREATH | Recruiting | NCT04430569 | 2018-000816-96 | NCT04430569, 2018-000816-96 | Interventional | DZL recruiting center | Externally - public | Beurteilung der Wirksamkeit einer thrombolytischen Therapie mit reduzierter Dosis bei Patienten mit akuter Lungenembolie mit intermediär-hohem Risiko an Tag 30. | Beurteilung der Wirksamkeit einer thrombolytischen Therapie mit reduzierter Dosis bei Patienten mit akuter Lungenembolie mit intermediär-hohem Risiko an Tag 30. | 10.06.21 | 31.12.25 | ||
| 51.168 | SOLACE | SOLACE | LC | Lung cancer | BREATH | Closed | Observational | DZL discovery-based | Externally - public | Backed by the expertise and network of all relevant European societies and stakeholders, SOLACE will assess the current state of play, needs and best practice of Lung Cancer Screening (LCS) in EU member states and produce a comprehensive guideline and implementation package covering all steps of the lung cancer screening pathway: evidence-based guidelines, technical papers, SOPs, documents regarding quality assurance, methodology, benefit-harm balance, cost-effectiveness. This package will be used to showcase de novo implementation. Moreover, SOLACE will design, plan and roll-out three pilot projects in 10 member states with more than 12000 participants to address key issues to increase participation: gender aspects, inequalities regarding hard-to-reach populations (social, ethnic, geographical) and higher risk individuals. | Backed by the expertise and network of all relevant European societies and stakeholders, SOLACE will assess the current state of play, needs and best practice of Lung Cancer Screening (LCS) in EU member states and produce a comprehensive guideline and implementation package covering all steps of the lung cancer screening pathway: evidence-based guidelines, technical papers, SOPs, documents regarding quality assurance, methodology, benefit-harm balance, cost-effectiveness. This package will be used to showcase de novo implementation. Moreover, SOLACE will design, plan and roll-out three pilot projects in 10 member states with more than 12000 participants to address key issues to increase participation: gender aspects, inequalities regarding hard-to-reach populations (social, ethnic, geographical) and higher risk individuals. | 01.04.23 | 31.03.26 | |||||
| 51.180 | TIGER Meso | TIGER Meso | LC | MPM | BIH / Charité - Associated Partner | Recruiting | NCT05538806 | NCT05538806 | Observational | DZL recruiting center | Externally - industry | TTFields in general routine clinical care in patients with pleural mesothelioma study | TTFields in general routine clinical care in patients with pleural mesothelioma study | 01.11.24 | 31.12.29 | |||
| 51.374 | Development of a novel non-invasive inflammometry following allergen challenge in patients with mild allergic asthma | Development of a novel non-invasive inflammometry following allergen challenge in patients with mild allergic asthma | AA | Mild Allergic Asthma | BREATH | Recruiting | NCT06317909 | NCT06317909 | Interventional | DZL recruiting center | DZL | The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma. The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath. The validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications. | The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma. The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath. The validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications. | 09.08.24 | 30.09.25 | |||
| 50.892 | A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | BREATH | Recruiting | 2022-502954-15-00 | 2022-502954-15-00 | Interventional | DZL recruiting center | Externally - industry | To assess the effect of axatilimab compared to placebo on lung function in subjects with IPF from baseline to Week 26 | To assess the effect of axatilimab compared to placebo on lung function in subjects with IPF from baseline to Week 26 | 05.11.24 | 31.12.25 | |||
| 50.918 | A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease | A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease | PALI | Infants and Children at Increased Risk for Severe RSV Disease | ARCN, BREATH | Active / not recruiting | NCT04938830 | NCT04938830 | Interventional | DZL recruiting center | Externally - industry | This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs). | This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs). | 16.12.22 | 27.10.25 | |||
| 50.940 | A Phase IIa/IIb, randomised, double blind, placebo-controlled, parallel-group dose-finding study to examine the efficacy and safety of BI 1839100 administered orally over a 12-week treatment period in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough | A Phase IIa/IIb, randomised, double blind, placebo-controlled, parallel-group dose-finding study to examine the efficacy and safety of BI 1839100 administered orally over a 12-week treatment period in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough | DPLD | Idiopathic Pulmonary Fibrosis (IPF) or progressive pulmonary fibrosis with clinically meaningful cough | BREATH | Recruiting | 2023-510249-79-00 | 2023-510249-79-00 | Interventional | DZL recruiting center | Externally - industry | Primary objective: To demonstrate a meaningful reduction from baseline in 24-h cough frequency (defined as the cough counts (CC) measured over 24 h and averaged per hour, i.e. CC/h) in the highest dose group of BI 1839100 compared with placebo after 4 weeks of treatment. Geometric means and mean ratios will be the summary measures of treatment effect for the change from baseline in each group and differences between treatment groups | Primary objective: To demonstrate a meaningful reduction from baseline in 24-h cough frequency (defined as the cough counts (CC) measured over 24 h and averaged per hour, i.e. CC/h) in the highest dose group of BI 1839100 compared with placebo after 4 weeks of treatment. Geometric means and mean ratios will be the summary measures of treatment effect for the change from baseline in each group and differences between treatment groups | 10.10.24 | 31.12.25 | |||
| 50.943 | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS; Roche WA42293 Starscape | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS; Roche WA42293 Starscape | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | BREATH, BIH / Charité - Associated Partner | Closed | NCT04552899 | 2020-000791-38 | NCT04552899, 2020-000791-38 | Interventional | DZL recruiting center | Externally - industry | This study will evaluate the efficacy, safety, and pharmacokinetics of PRM-151 compared with placebo in patients with IPF. | This study will evaluate the efficacy, safety, and pharmacokinetics of PRM-151 compared with placebo in patients with IPF. | 17.12.21 | 15.06.23 | ||
| 50.949 | A Phase IIIb randomized open-label pragmatic study to evaluate the efficacy and safety of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus (RSV) in infants (HARMONIE) | A Phase IIIb randomized open-label pragmatic study to evaluate the efficacy and safety of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus (RSV) in infants (HARMONIE) | PALI | infants (no specific disease) | BREATH | Closed | NCT05437510 | NCT05437510 | Interventional | DZL recruiting center | Externally - industry | The purpose of this study is to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to that of no intervention for the prevention of hospitalizations due to LRTI caused by confirmed RSV in all infants under 12 months of age who are not eligible to receive palivizumab. | The purpose of this study is to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to that of no intervention for the prevention of hospitalizations due to LRTI caused by confirmed RSV in all infants under 12 months of age who are not eligible to receive palivizumab. | 28.09.22 | 30.09.24 | |||
| 50.960 | A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF) | A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF) | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | BREATH | Active / not recruiting | 2023-506185-31-00 | 2023-506185-31-00 | Interventional | DZL recruiting center | Externally - industry | To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52 | To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52 | 28.08.24 | 28.02.25 | |||
| 50.972 | A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects with Idiopathic Pulmonary Fibrosis | A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects with Idiopathic Pulmonary Fibrosis | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | BREATH | Closed | 2021-003162-12 | 2021-003162-12 | Interventional | DZL recruiting center | Externally - industry | This is a prospective, randomized, double-blind, placebo-controlled study to investigate the safety, PK, and PD of CSL312 in patients with IPF. Approximately 80 patients with a confirmed diagnosis of IPF will be enrolled and randomized to treatment in a 1:1 ratio; to achieve a total of 70 evaluable subjects by Week 14; 35 subjects in the CSL312 600 mg group and 35 subjects in the placebo group. | This is a prospective, randomized, double-blind, placebo-controlled study to investigate the safety, PK, and PD of CSL312 in patients with IPF. Approximately 80 patients with a confirmed diagnosis of IPF will be enrolled and randomized to treatment in a 1:1 ratio; to achieve a total of 70 evaluable subjects by Week 14; 35 subjects in the CSL312 600 mg group and 35 subjects in the placebo group. | 18.05.22 | 02.10.23 | |||
| 51.003 | ALPINE - A Phase II, Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung (TUD ALPINE) | ALPINE - A Phase II, Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung (TUD ALPINE) | LC | LCNEC | BIH / Charité - Associated Partner, TLRC | Active / not recruiting | NCT05470595 | 2020-002683-31 | NCT05470595, 2020-002683-31 | Interventional | DZL recruiting center | Externally - public, Externally - industry | A Phase II, single-arm trial of Atezolizumab/Platinum/Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung; This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC. | A Phase II, single-arm trial of Atezolizumab/Platinum/Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung; This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC. | 18.01.21 | 31.01.29 | ||
| 51.030 | CADPT09A12201: A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis | CADPT09A12201: A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | CPC-M | Closed | 2021-005056-61 | 2021-005056-61 | Interventional | DZL recruiting center | Externally - industry | The purpose of this proof-of-concept platform study is to determine whether selected systemic investigational products have an adequate clinical profile to support further clinical development in mild to moderate IPF. This platform design allows several investigational drugs | The purpose of this proof-of-concept platform study is to determine whether selected systemic investigational products have an adequate clinical profile to support further clinical development in mild to moderate IPF. This platform design allows several investigational drugs | 01.02.23 | 31.12.26 | |||
| 51.069 | eurILDregistry | eurILDregistry | DPLD | Interstitielle Lungenerkrankungen (ILD) | Associated Partner | Recruiting | Observational | DZL Investigator Initiated Trial | DZL | Observing intestinal and rare ILD | Observing intestinal and rare ILD | 01.07.22 | 01.07.42 | |||||
| 51.071 | European Management platform for childhood Interstitial Lung Diseases – child-EU Register und Biobank (child-EU) | European Management platform for childhood Interstitial Lung Diseases – child-EU Register und Biobank (child-EU) | DPLD | Interstitielle Lungenerkrankungen (ILD) | UGMLC | Recruiting | NCT02852928 | NCT02852928 | Observational | DZL recruiting center, DZL Investigator Initiated Trial | Externally - public | Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of outcomes used in child Assess treatment variations used, deliver data from defined protocols and linked outcomes. | Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of outcomes used in child Assess treatment variations used, deliver data from defined protocols and linked outcomes. | 01.12.13 | 01.12.29 | |||
| 51.089 | INSIGHTS-ILD | INSIGHTS-ILD | DPLD | Interstitielle Lungenfibrose | BIH / Charité - Associated Partner | Recruiting | Observational | DZL recruiting center | Externally - public | Register zur Untersuchung signifikanter Gesundheitstrends bei progressiv fibrosierender interstitieller Lungenfibrose | Register zur Untersuchung signifikanter Gesundheitstrends bei progressiv fibrosierender interstitieller Lungenfibrose | 03.01.24 | 31.12.25 | |||||
| 51.091 | INSURF-IPF | INSURF-IPF | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | Associated Partner | Recruiting | Interventional | DZL Investigator Initiated Trial | DZL | Studie ist noch in der Vorbereitung und soll im kommenden Jahr starten. IIT München/Giessen | Studie ist noch in der Vorbereitung und soll im kommenden Jahr starten. IIT München/Giessen | 01.01.25 | 31.12.25 | |||||
| 51.095 | INVESTIGATING SIGNIFICANT HEALTH TRENDS IN IDIOPATHIC PULMONARY FIBROSIS (INSIGHTS-IPF) NATIONWIDE PROSPECTIVE REGISTRY | INVESTIGATING SIGNIFICANT HEALTH TRENDS IN IDIOPATHIC PULMONARY FIBROSIS (INSIGHTS-IPF) NATIONWIDE PROSPECTIVE REGISTRY | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | BREATH | Closed | NCT01695408 | NCT01695408 | Observational | DZL recruiting center | Externally - public | The overall objective of the present IPF Registry is to gain further insight on the characteristics and management of patients with IPF, as treated under real-life, clinical practice conditions. The project aims to provide information on disease characteristics (disease registry, burden of disease), treatment patterns (pharmacoepidemiology), long-term effects (outcomes registry), quality of life, and economic aspects | The overall objective of the present IPF Registry is to gain further insight on the characteristics and management of patients with IPF, as treated under real-life, clinical practice conditions. The project aims to provide information on disease characteristics (disease registry, burden of disease), treatment patterns (pharmacoepidemiology), long-term effects (outcomes registry), quality of life, and economic aspects | 01.09.16 | 31.10.21 | |||
| 51.115 | MBS2320-IST-07 | MBS2320-IST-07 | DPLD | Interstitielle Lungenerkrankungen (ILD) | Associated Partner | Closed | Interventional | DZL recruiting center | Externally - industry | Studie wurde im Mai 2024 gestoppt auf Grund von Laborproblemen. | Studie wurde im Mai 2024 gestoppt auf Grund von Laborproblemen. | 01.02.24 | 01.05.24 | |||||
| 51.128 | Nitto Denko ND 202-S0201-005 | Nitto Denko ND 202-S0201-005 | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | Associated Partner | Closed | 2014-004882-26 | 2014-004882-26 | Interventional | DZL recruiting center | Externally - industry | Keine Patienten, da keine Studienassistenz vorhanden | Keine Patienten, da keine Studienassistenz vorhanden | 16.09.20 | 07.06.22 | |||
| 51.144 | Pliant BEACON PLN-74809-IPF-206 | Pliant BEACON PLN-74809-IPF-206 | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | Associated Partner | Recruiting | 2022-000083-21 | 2022-000083-21 | Interventional | DZL recruiting center | Externally - industry | Studie wurde Ende Oktober durch das BfS gestoppt. Warten auf Klärung. | Studie wurde Ende Oktober durch das BfS gestoppt. Warten auf Klärung. | 01.01.25 | 01.01.26 | |||
| 51.371 | Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis | Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis | COPD | Idiopathic Pulmonary Fibrosis (IPF) | BREATH | Recruiting | NCT06589219 | NCT06589219 | Interventional | DZL recruiting center | Externally - industry | The purpose of this study is to assess the safety, tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF). | The purpose of this study is to assess the safety, tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF). | 19.08.24 | 31.03.26 | |||
| 51.372 | Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate | Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate | COPD | Infection | BREATH | Closed | NCT05226390 | NCT05226390 | Interventional | DZL recruiting center | Externally - public | This will be a phase I, single-center trial, including a total of 30 participants in two cohorts. Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST. | This will be a phase I, single-center trial, including a total of 30 participants in two cohorts. Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST. | 24.02.22 | 21.11.23 | |||
| 51.373 | Specialist Network Infectious Diseases (SNID) | Specialist Network Infectious Diseases (SNID) | PALI | infectious diseases | ARCN, UGMLC, BIH / Charité - Associated Partner | Not yet recruiting | Observational | DZL recruiting center | Externally - public | As part of the European concept of ever-warm recruiting infrastructures in case of future public health hazards, but also as instrument for answering pressing questions in the field of major infectious diseases, the SNID cohort collects clinical patient data and biosamples in a standardized and quality-assured manner. In this sense, the SNID manifests itself as a structured data and decentralized biobank within the German Network University Medicine (NUM). | As part of the European concept of ever-warm recruiting infrastructures in case of future public health hazards, but also as instrument for answering pressing questions in the field of major infectious diseases, the SNID cohort collects clinical patient data and biosamples in a standardized and quality-assured manner. In this sense, the SNID manifests itself as a structured data and decentralized biobank within the German Network University Medicine (NUM). | 01.06.24 | 31.12.30 | |||||
| 50.890 | 1305-0014 (FIBRONEERTM – IPF): A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF) | 1305-0014 (FIBRONEERTM – IPF): A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF) | DPLD | ideopathic pulmonary disease | BREATH, CPC-M | Closed | 2022-001091-34 | 2022-001091-34 | Interventional | DZL recruiting center | Externally - industry | The primary objective is to demonstrate a reduction in lung function decline as measured by the change from baseline in FVC for BI 1015550 when compared to placebo in patients with IPF. The main secondary objective of the trial is to demonstrate BI 1015550’s ability in reducing the occurrence of clinically meaningful events such as acute IPF exacerbation, hospitalization for respiratory cause or death over the duration of the trial when compared to placebo in patients with IPF. An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung function. | The primary objective is to demonstrate a reduction in lung function decline as measured by the change from baseline in FVC for BI 1015550 when compared to placebo in patients with IPF. The main secondary objective of the trial is to demonstrate BI 1015550’s ability in reducing the occurrence of clinically meaningful events such as acute IPF exacerbation, hospitalization for respiratory cause or death over the duration of the trial when compared to placebo in patients with IPF. An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung function. | 22.12.22 | 31.12.24 | |||
| 50.894 | A double blind, randomised, placebo-controlled trial to evaluate the doseexposure and safety of nintedanib per os on top of standard of care for 24 weeks, followed by open label treatment with nintedanib of variable duration, in children and adolescents (6 to 17 year-old) with clinically significant fibrosing Interstitial Lung Disease. (Boehringer Interstitial Lung Disease (ILD) 1199-0337) | A double blind, randomised, placebo-controlled trial to evaluate the doseexposure and safety of nintedanib per os on top of standard of care for 24 weeks, followed by open label treatment with nintedanib of variable duration, in children and adolescents (6 to 17 year-old) with clinically significant fibrosing Interstitial Lung Disease. (Boehringer Interstitial Lung Disease (ILD) 1199-0337) | DPLD | Diffuse Parenchymal Lung Disease (DPLD) | BIH / Charité - Associated Partner | Closed | NCT04093024 | 2018-004530-14 | NCT04093024, 2018-004530-14 | Interventional | DZL recruiting center | Externally - industry | The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. | The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. | 25.05.21 | 24.05.22 | ||
| 50.899 | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-Week Phase III Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-Week Phase III Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) | AA | Hypereosinophilic syndrome (HES) | BREATH | Closed | 2019-002039-27 | 2019-002039-27 | Interventional | DZL recruiting center | Externally - industry | To evaluate the effect of benralizumab on the time to first HES worsening/flare | To evaluate the effect of benralizumab on the time to first HES worsening/flare | 07.06.21 | 02.05.24 | |||
| 50.903 | A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis | A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis | DPLD | Idiopathic Pulmonary Fibrosis (IPF) | BREATH | Closed | 2021-005066-17 | 2021-005066-17 | Interventional | DZL recruiting center | Externally - industry | The primary objective of this study is to assess the efficacy of the investigational products compared to placebo in participants with IPF measured by FVC expressed in percent predicted. | The primary objective of this study is to assess the efficacy of the investigational products compared to placebo in participants with IPF measured by FVC expressed in percent predicted. | 07.06.23 | 24.10.24 | |||
| 50.953 | A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma (TIPP) | A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma (TIPP) | AA | early childhood asthma | BREATH, CPC-M | Suspended, Closed | 2021-000190-81 | 2021-000190-81 | Interventional | DZL recruiting center | Externally - public | The primary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS prevents severe exacerbations. | The primary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS prevents severe exacerbations. | 29.12.21 | 28.02.25 | |||
| 51.010 | An open-label trial of the long-term safety and tolerability of nintedanib per os, on top of standard of care, over at least 2 years, in children and adolescents with clinically significant fibrosing Interstitial Lung Disease (InPedILD®-ON) (1199-0378 | An open-label trial of the long-term safety and tolerability of nintedanib per os, on top of standard of care, over at least 2 years, in children and adolescents with clinically significant fibrosing Interstitial Lung Disease (InPedILD®-ON) (1199-0378 | DPLD | Diffuse Parenchymal Lung Disease (DPLD) | BIH / Charité - Associated Partner | Closed | NCT05285982 | 2020-005554-23 | NCT05285982, 2020-005554-23 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The main objective of the trial is to assess the safety and tolerability of long-term treatment with nintedanib in pediatric patients with clinically significant fibrosing ILD. | The main objective of the trial is to assess the safety and tolerability of long-term treatment with nintedanib in pediatric patients with clinically significant fibrosing ILD. | 20.09.22 | 11.08.25 | ||
| 51.034 | CF Register und Biobank - Observational study on the course of disease in patients with (suspected) chronic upper and lower respiratory tract diseases (TRACK PCD/CLD) | CF Register und Biobank - Observational study on the course of disease in patients with (suspected) chronic upper and lower respiratory tract diseases (TRACK PCD/CLD) | CFBE | Cystic Fibrosis | ARCN, BIH / Charité - Associated Partner, BREATH, UGMLC, TLRC | Recruiting | DRKS00031784 | DRKS00031784 | Observational | DZL recruiting center, DZL Investigator Initiated Trial, DZL on steering board | DZL | A multi-centre longitudinal study establishing a bio- and DNA bank for current and future research projects as well as establishing a registry with the essential clinical data of patients with cystic fibrosis for correlation with disease-modifying genes, new biomarkers and (new) cystic fibrosis pathogens for current and future research projects. Observational study, the registry should contain the essential clinical data of the patients (e.g. lung function findings, pathogen spectrum in the lungs, systemic inflammation) to enable the correlation of clinical parameters with disease-modifying genes, new CF pathogens, new biomarkers and CFTR function with and without therapeutic intervention. Establishment of a bio- and DNA bank for current and future research projects as well as establishment of a registry with the essential clinical data of patients with cystic fibrosis for correlation with disease-modifying genes, new biomarkers and (new) cystic fibrosis pathogens for current and future research projects. | A multi-centre longitudinal study establishing a bio- and DNA bank for current and future research projects as well as establishing a registry with the essential clinical data of patients with cystic fibrosis for correlation with disease-modifying genes, new biomarkers and (new) cystic fibrosis pathogens for current and future research projects. Observational study, the registry should contain the essential clinical data of the patients (e.g. lung function findings, pathogen spectrum in the lungs, systemic inflammation) to enable the correlation of clinical parameters with disease-modifying genes, new CF pathogens, new biomarkers and CFTR function with and without therapeutic intervention. Establishment of a bio- and DNA bank for current and future research projects as well as establishment of a registry with the essential clinical data of patients with cystic fibrosis for correlation with disease-modifying genes, new biomarkers and (new) cystic fibrosis pathogens for current and future research projects. | 25.04.18 | 01.05.50 | |||
| 51.038 | COACH (=Chronic Conditions in Adolescents: Implementation and Evaluation of Patient-centred Collaborative Healthcare) | COACH (=Chronic Conditions in Adolescents: Implementation and Evaluation of Patient-centred Collaborative Healthcare) | CFBE | Cystic Fibrosis | BREATH, BIH / Charité - Associated Partner | Closed | DRKS00016714, DRKS00014043 | DRKS00016714, DRKS00014043 | Observational | DZL recruiting center | Externally - public | Within the scope of COACH, mental comorbidities shall be recognized at an early stage, their treatment shall be optimized and they shall be better understood. On basis of study outcomes, evidence-based recommendations for collaborative healthcare of concerned adolescents ought to be provided. | Within the scope of COACH, mental comorbidities shall be recognized at an early stage, their treatment shall be optimized and they shall be better understood. On basis of study outcomes, evidence-based recommendations for collaborative healthcare of concerned adolescents ought to be provided. | 12.10.20 | 04.03.22 | |||
| 51.039 | Coaching and telemonitoring of prescribed inhalation therapies in patients with cystic fibrosis (ConneCT CF) | Coaching and telemonitoring of prescribed inhalation therapies in patients with cystic fibrosis (ConneCT CF) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner | Closed | DRKS00024642 | DRKS00024642 | Interventional | DZL recruiting center, DZL Investigator Initiated Trial, DZL on steering board | Externally - public | A randomized interventional study on continuous telemonitoring of adherence to inhalation therapy | A randomized interventional study on continuous telemonitoring of adherence to inhalation therapy | 17.11.20 | 31.05.24 | |||
| 51.050 | Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators (Modulate-CF) | Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators (Modulate-CF) | CFBE | Cystic Fibrosis | TLRC, BREATH, UGMLC, BIH / Charité - Associated Partner | Recruiting | NCT04732910 | NCT04732910 | Observational | DZL recruiting center, DZL Investigator Initiated Trial, DZL on steering board | DZL, Externally - industry | This observational study evaluates the effect of therapy with cystic fibrosis transmembrane regulator (CFTR) modulators on CFTR function measured by the CFTR biomarker intestinal current measurement (ICM), nasal potential difference (NPD) and sweat chloride in a post-approval setting in patients with cystic fibrosis (CF). | This observational study evaluates the effect of therapy with cystic fibrosis transmembrane regulator (CFTR) modulators on CFTR function measured by the CFTR biomarker intestinal current measurement (ICM), nasal potential difference (NPD) and sweat chloride in a post-approval setting in patients with cystic fibrosis (CF). | 01.07.18 | 31.12.27 | |||
| 51.054 | Deutsches Mukoviszidose-Register | Deutsches Mukoviszidose-Register | CFBE | Cystic Fibrosis | UGMLC | Recruiting | Observational | DZL recruiting center | DZL | The goal of the Cystic Fibrosis Registry is to establish a basis for the continuous improvement of the quality of treatment for patients with cystic fibrosis through the structured collection and statistical evalua-tion of the registry data (“quality assurance for cystic fibrosis”). The primary goals are: • To record, analyse and improve the care situation of patients with cystic fibrosis in Germany, • to provide the collected data as the foundation for healthcare research, development of therapy and to monitor the safety of pharmaceutical medicines, • to prepare the registry data for patients and therapists and to portray it in a transparent manner in annually issued reports. Furthermore, the registry data of participating CF-institutions offers the possibility of internal quality assurance. | The goal of the Cystic Fibrosis Registry is to establish a basis for the continuous improvement of the quality of treatment for patients with cystic fibrosis through the structured collection and statistical evalua-tion of the registry data (“quality assurance for cystic fibrosis”). The primary goals are: • To record, analyse and improve the care situation of patients with cystic fibrosis in Germany, • to provide the collected data as the foundation for healthcare research, development of therapy and to monitor the safety of pharmaceutical medicines, • to prepare the registry data for patients and therapists and to portray it in a transparent manner in annually issued reports. Furthermore, the registry data of participating CF-institutions offers the possibility of internal quality assurance. | 01.04.19 | 01.01.28 | |||||
| 51.067 | Entwicklung und Validierung eines Kinderfragebogens zur Erfassung abdomineller Beschwerden bei Patienten mit Mukoviszidose (CF) auf Grundlage des CFAbd-Scores (CFAbd-Score Kid1 und Kid2) | Entwicklung und Validierung eines Kinderfragebogens zur Erfassung abdomineller Beschwerden bei Patienten mit Mukoviszidose (CF) auf Grundlage des CFAbd-Scores (CFAbd-Score Kid1 und Kid2) | CFBE | Cystic Fibrosis | UGMLC | Recruiting | Observational | DZL recruiting center | DZL | Development and validation of a children's questionnaire to record abdominal discomfort in patients with cystic fibrosis (CF) based on the CFAbd score (CFAbd Score Kid1 and Kid2) | Development and validation of a children's questionnaire to record abdominal discomfort in patients with cystic fibrosis (CF) based on the CFAbd score (CFAbd Score Kid1 and Kid2) | 01.07.22 | 01.01.28 | |||||
| 51.073 | Evaluation of a therapeutic drug monitoring (TDM) program of CFTR modulators | Evaluation of a therapeutic drug monitoring (TDM) program of CFTR modulators | CFBE | Cystic Fibrosis | TLRC, CPC-M | Recruiting | Observational | DZL Investigator Initiated Trial | DZL | Measurement of serum concentrations for elexa-caftor/tezacaftor/ivacaftor from routine blood samples and joint evaluation with the TDM program for CFTR modu-lators of the LMU Munich | Measurement of serum concentrations for elexa-caftor/tezacaftor/ivacaftor from routine blood samples and joint evaluation with the TDM program for CFTR modu-lators of the LMU Munich | 01.08.24 | 31.03.25 | |||||
| 51.078 | FUNLUM | FUNLUM | AA | Eosinophilic Asthma | BREATH | Recruiting | NCT04512521 | NCT04512521 | Interventional | DZL recruiting center, DZL discovery-based | Externally - public | Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled under maximal therapy or if they are only controlled under oral corticosteroids. Functional lung MRI has the potential to show early changes in lung microstructure, regional ventilation and perfusion and thus has the potential for early detection of therapy response. | Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled under maximal therapy or if they are only controlled under oral corticosteroids. Functional lung MRI has the potential to show early changes in lung microstructure, regional ventilation and perfusion and thus has the potential for early detection of therapy response. | 04.05.20 | 31.08.25 | |||
| 51.110 | Longitudinal observational study on the course of Cystic Fibrosis Lung Disease in patients following newborn screening (TRACK-CF) | Longitudinal observational study on the course of Cystic Fibrosis Lung Disease in patients following newborn screening (TRACK-CF) | CFBE | Cystic Fibrosis | ARCN, BREATH, UGMLC, TLRC, BIH / Charité - Associated Partner | Recruiting | NCT02270476 | NCT02270476 | Observational | DZL Investigator Initiated Trial, DZL recruiting center, DZL on steering board | DZL | Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients following Newborn Screening. The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF). | Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients following Newborn Screening. The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF). | 01.12.11 | 01.05.50 | |||
| 51.116 | Messungen des intestinalen Ionenstroms als Biomarker zur Beurteilung der Aktivierung von mutantem CFTR in Patienten mit Mukoviszidose (6 Jahre und älter), die homozygot für p.Phe508del oder compound heterozygot für p.Phe508del und eine ‚Minimal Function‘ Mutation sind und bei denen eine klinische Indikation für die Kombinationsbehandlung mit Elexacaftor, Tezacaftor und Ivacaftor (Handelsname: Kaftrio®) besteht - Eine Post-Approval Anwendungsbeobachtung – | Messungen des intestinalen Ionenstroms als Biomarker zur Beurteilung der Aktivierung von mutantem CFTR in Patienten mit Mukoviszidose (6 Jahre und älter), die homozygot für p.Phe508del oder compound heterozygot für p.Phe508del und eine ‚Minimal Function‘ Mutation sind und bei denen eine klinische Indikation für die Kombinationsbehandlung mit Elexacaftor, Tezacaftor und Ivacaftor (Handelsname: Kaftrio®) besteht - Eine Post-Approval Anwendungsbeobachtung – | CFBE | Cystic Fibrosis | UGMLC | Recruiting | Observational | DZL recruiting center, DZL Investigator Initiated Trial | Externally - public | Intestinal current measurements (ICM) as biomarker to evaluate the activation of mutant CFTR in subjects with cystic fibrosis aged 6 years and older, homozygous for the p.Phe508del-CFTR mutation or com-pound heterozygous for p.Phe508del-CFTR and a minimal function mutation, for whom the clinical indication is met for triple-CFTR-modulator therapy with elexacaftor in combination with tezacaftor and ivacaftor (brand name: Kaftrio®) -A post-approval observational study- | Intestinal current measurements (ICM) as biomarker to evaluate the activation of mutant CFTR in subjects with cystic fibrosis aged 6 years and older, homozygous for the p.Phe508del-CFTR mutation or com-pound heterozygous for p.Phe508del-CFTR and a minimal function mutation, for whom the clinical indication is met for triple-CFTR-modulator therapy with elexacaftor in combination with tezacaftor and ivacaftor (brand name: Kaftrio®) -A post-approval observational study- | 01.09.20 | 01.01.28 | |||||
| 51.130 | Nocturnal digital cough monitoring in people with Cystic Fibrosis (VIA Cough) | Nocturnal digital cough monitoring in people with Cystic Fibrosis (VIA Cough) | CFBE | Cystic Fibrosis and non CF bronchiectasis | BIH / Charité - Associated Partner, BREATH | Recruiting | DRKS00035481 | DRKS00035481 | Observational | DZL recruiting center, DZL Investigator Initiated Trial, DZL on steering board | Externally - industry | Multicenter Study, Control of Lung disease in patients with CF and non CF bronchiectasis using continuous noctornal digital cough monitoring | Multicenter Study, Control of Lung disease in patients with CF and non CF bronchiectasis using continuous noctornal digital cough monitoring | 08.10.24 | 30.06.26 | |||
| 51.140 | Patient Stratification by Standardization of the Image-based Sweat Test for Cystic Fibrosis foruse in Clinical Routine - Stracyfic | Patient Stratification by Standardization of the Image-based Sweat Test for Cystic Fibrosis foruse in Clinical Routine - Stracyfic | CFBE | Cystic Fibrosis | BREATH | Recruiting | Observational | DZL recruiting center | Externally - public | Stracyfic will offer a novel strategy to better classify and monitor patients by their individual level of the disease-causing effect. Enabling better detection as well as better management of the disease in the long run. | Stracyfic will offer a novel strategy to better classify and monitor patients by their individual level of the disease-causing effect. Enabling better detection as well as better management of the disease in the long run. | 05.11.24 | 31.05.26 | |||||
| 51.177 | Therapeutic Drug Monitoring of CFTR-Modulators to advance pharmacokinetic modeling and Bayesian Dose Adjustments | Therapeutic Drug Monitoring of CFTR-Modulators to advance pharmacokinetic modeling and Bayesian Dose Adjustments | CFBE | Cystic Fibrosis | CPC-M, TLRC | Closed | Observational | DZL Investigator Initiated Trial | DZL | We included 155 adult patienst at CPC-M, TLRC is still ongoing | We included 155 adult patienst at CPC-M, TLRC is still ongoing | 01.02.23 | 31.12.23 | |||||
| 51.370 | TERS & SIPAT: Optimierung der psychosozialen Evaluation bei Patientinnen und Patienten vor Lungentransplantation | TERS & SIPAT: Optimierung der psychosozialen Evaluation bei Patientinnen und Patienten vor Lungentransplantation | ROR | End-stage lung disease / lung transplant (candidates) | BREATH | Recruiting | Observational | DZL Investigator Initiated Trial | DZL | Im Rahmen dieser Studie werden Patient:innen vor Aufnahme auf die Warteliste zur Lungentransplantation mit einem strukturierten Experten-basierten Interview zu untersucht. Während für diese Interviews bislang der TERS (Transplant Evaluation Rating Scale) verwendet wurde, wird im Rahmen der beantragten Studie zusätzlich den SIPAT (Stanford Integrated Psychosocial Assessment for Transplantation) eingesetzt mit dem Ziel der Erzielung differenzierterer Erkenntnisse und weiterer Informationen zur prädiktiven Aussagekraft psychosozialer Faktoren. | Im Rahmen dieser Studie werden Patient:innen vor Aufnahme auf die Warteliste zur Lungentransplantation mit einem strukturierten Experten-basierten Interview zu untersucht. Während für diese Interviews bislang der TERS (Transplant Evaluation Rating Scale) verwendet wurde, wird im Rahmen der beantragten Studie zusätzlich den SIPAT (Stanford Integrated Psychosocial Assessment for Transplantation) eingesetzt mit dem Ziel der Erzielung differenzierterer Erkenntnisse und weiterer Informationen zur prädiktiven Aussagekraft psychosozialer Faktoren. | 01.01.24 | 31.12.26 | |||||
| 50.902 | A Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis Less Than 12 Months of Age | A Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis Less Than 12 Months of Age | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, TLRC | Recruiting | NCT06506773 | NCT06506773 | Observational | DZL recruiting center, DZL on steering board | Externally - industry | The objective of the study is to characterize the natural history of exocrine pancreatic function as measured by FE-1 in infants with CF <12 months of age | The objective of the study is to characterize the natural history of exocrine pancreatic function as measured by FE-1 in infants with CF | 17.10.24 | 01.08.26 | |||
| 50.913 | A phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluation the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and older with a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | A phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluation the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and older with a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, UGMLC, BREATH, CPC-M | Closed | NCT05274269 | 2021-005320-38 | NCT05274269, 2021-005320-38 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | This study evaluated the efficacy, pharmacodynamics (PD) and safe-ty of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation. | This study evaluated the efficacy, pharmacodynamics (PD) and safe-ty of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation. | 01.05.22 | 06.10.23 | ||
| 50.914 | A Phase 3 Open-label Study Evaluating the Long‑term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older Vertex Study Number: VX20-445-112 | A Phase 3 Open-label Study Evaluating the Long‑term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older Vertex Study Number: VX20-445-112 | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner | Closed | NCT05153317 | 2020-002239-31 | NCT05153317, 2020-002239-31 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The primary objective of the study is to evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in cystic fibrosis (CF) subjects 2 years of age and older | The primary objective of the study is to evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in cystic fibrosis (CF) subjects 2 years of age and older | 25.03.22 | 01.04.26 | ||
| 50.916 | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX‑121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX‑121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, BREATH | Recruiting | NCT05422222 | 2021-005930-40, 2024-513754-29-00 | NCT05422222, 2021-005930-40, 2024-513754-29-00 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. To evaluate the safety and tolerability of VX-121/TEZ/D-IVA | The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. To evaluate the safety and tolerability of VX-121/TEZ/D-IVA | 20.02.23 | 30.06.30 | ||
| 50.917 | A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age (VX20-445-111 B) | A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age (VX20-445-111 B) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, UGMLC | Closed | NCT04537793 | 2020-002251-38 | NCT04537793, 2020-002251-38 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The primary objective of the study is to evaluate the PK of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC); To evaluate the safety and tolerability of ELX/TEZ/IVA; | The primary objective of the study is to evaluate the PK of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC); To evaluate the safety and tolerability of ELX/TEZ/IVA; | 05.10.21 | 03.06.22 | ||
| 50.919 | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older | CFBE | Cystic Fibrosis | BREATH, BIH / Charité - Associated Partner | Enrolling by invitation | NCT06460506 | 2023-509563-24-00 | NCT06460506, 2023-509563-24-00 | Interventional | DZL recruiting center | Externally - industry | The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA). | The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA). | 12.11.24 | 30.09.27 | ||
| 50.920 | A Phase 3, open-label study evaluating the Long-term safety and efficacy of VX-121 combination therapy in subjects with Cystic Fibrosis (VX20-121-104) | A Phase 3, open-label study evaluating the Long-term safety and efficacy of VX-121 combination therapy in subjects with Cystic Fibrosis (VX20-121-104) | CFBE | Cystic Fibrosis | UGMLC, BIH / Charité - Associated Partner | Active / not recruiting | NCT05444257 | 2021-000713-17, 2024-514173-22-00 | NCT05444257, 2021-000713-17, 2024-514173-22-00 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis. | The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis. | 01.11.22 | 31.10.26 | ||
| 50.925 | A Phase 3, Open-label Study Evaluating the Long‑term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older | A Phase 3, Open-label Study Evaluating the Long‑term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older | CFBE | Cystic Fibrosis | BREATH, BIH / Charité - Associated Partner | Enrolling by invitation | NCT05844449 | 2022-503081-74-00 | NCT05844449, 2022-503081-74-00 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The primary objective of the study is to evaluate the long-term safety and tolerability of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) | The primary objective of the study is to evaluate the long-term safety and tolerability of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) | 05.09.23 | 31.10.30 | ||
| 50.927 | A Phase 3, Open-label Study Evaluating the Pharmacokinetics, Safety, and Tolerability of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 to Less Than 24 Months of Age | A Phase 3, Open-label Study Evaluating the Pharmacokinetics, Safety, and Tolerability of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 to Less Than 24 Months of Age | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, BREATH | Recruiting | NCT05882357 | 2023-503230-49-00 | NCT05882357, 2023-503230-49-00 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | This study will evaluate the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF subjects 12 to less than (<) 24 months of age. To evaluate the safety and tolerability of ELX/TEZ/IVA | This study will evaluate the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF subjects 12 to less than ( | 05.02.24 | 31.10.25 | ||
| 50.930 | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, BREATH, CPC-M | Closed | NCT05033080 | 2021-000712-31 | NCT05033080, 2021-000712-31 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The primary objective of the study is to evaluate the efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in cystic fibrosis (CF) subjects who are heterozygous for F508del and a minimal function mutation (F/MF subjects) | The primary objective of the study is to evaluate the efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in cystic fibrosis (CF) subjects who are heterozygous for F508del and a minimal function mutation (F/MF subjects) | 18.02.22 | 17.01.24 | ||
| 50.935 | A Phase 3b, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexa-caftor/Tezacaftor/Ivacaftor Combination in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) (VX20-445-119) | A Phase 3b, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexa-caftor/Tezacaftor/Ivacaftor Combination in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) (VX20-445-119) | CFBE | Cystic Fibrosis | UGMLC, BIH / Charité - Associated Partner | Closed | NCT04545515 | 2020-001404-42 | NCT04545515, 2020-001404-42 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in par-ticipants with CF who are 6 years of age and older with F/MF geno-types. | The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in par-ticipants with CF who are 6 years of age and older with F/MF geno-types. | 01.01.21 | 24.03.24 | ||
| 50.939 | A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutaneous administration of anakinra in patients with cystic fibrosis.(ANAKIN) | A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutaneous administration of anakinra in patients with cystic fibrosis.(ANAKIN) | CFBE | Cystic Fibrosis | TLRC, BIH / Charité - Associated Partner | Recruiting | NCT03925194 | 2023-510376-31-00 | NCT03925194, 2023-510376-31-00 | Interventional | DZL recruiting center, DZL Investigator Initiated Trial, DZL discovery-based, DZL on steering board | DZL | The primary objective of the study is to evaluate efficacy of treatment with anakinra in subjects with cystic fibrosis (CF) by means of lung clearance index (LCI) in adults and in addition in adolescents if effective in adults. | The primary objective of the study is to evaluate efficacy of treatment with anakinra in subjects with cystic fibrosis (CF) by means of lung clearance index (LCI) in adults and in addition in adolescents if effective in adults. | 01.09.19 | 01.01.27 | ||
| 50.941 | A Phase IIb, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Subjects with Cystic Fibrosis Aged 18 Years or Older (HIT-CF-CHOICES) | A Phase IIb, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Subjects with Cystic Fibrosis Aged 18 Years or Older (HIT-CF-CHOICES) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, BREATH | Recruiting | NCT06468527 | 2022-500410-26-01 | NCT06468527, 2022-500410-26-01 | Interventional | DZL recruiting center | Externally - public | The primary objective of the study is to evaluate the efficacy of DIR/POS/NES after 8 weeks compared to placebo in (a) CF patients with rare CFTR mutations and a high organoid response to DIR/POS/NES and (b) CF patients with rare CFTR mutations not pre-selected on organoid response. | The primary objective of the study is to evaluate the efficacy of DIR/POS/NES after 8 weeks compared to placebo in (a) CF patients with rare CFTR mutations and a high organoid response to DIR/POS/NES and (b) CF patients with rare CFTR mutations not pre-selected on organoid response. | 12.07.24 | 01.06.25 | ||
| 50.950 | A Phase3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects with Cystic Fibro-sis who are Homozygous for F508del or Heterozy-gous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation (VX20-121-103) | A Phase3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects with Cystic Fibro-sis who are Homozygous for F508del or Heterozy-gous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation (VX20-121-103) | CFBE | Cystic Fibrosis | UGMLC, BIH / Charité - Associated Partner | Closed | NCT05076149 | 2021-000694-85 | NCT05076149, 2021-000694-85 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation. | The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation. | 01.12.21 | 30.11.23 | ||
| 50.956 | A Randomised, Double-Blind, Placebo Controlled, Two-Part Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Repeat Dose of Inhaled ETD001 in People with Cystic Fibrosis (ET-ENAC-03) | A Randomised, Double-Blind, Placebo Controlled, Two-Part Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Repeat Dose of Inhaled ETD001 in People with Cystic Fibrosis (ET-ENAC-03) | CFBE | Cystic Fibrosis | CPC-M, BIH / Charité - Associated Partner | Recruiting | 2023-504092-25-00 | 2023-504092-25-00 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The primary objective of the study is to assess the safety and tolerability of repeat inhaled doses of ETD001 in pwCF, compared to placebo(Part A) and to assess the effect of repeat inhaled doses of ETD001 on percent predicted forced expiratory (Part B) volume in 1 second (ppFEV1) in pwCF, compared to placebo. Until now we included 2 pt., plan to include 1-2 more. | The primary objective of the study is to assess the safety and tolerability of repeat inhaled doses of ETD001 in pwCF, compared to placebo(Part A) and to assess the effect of repeat inhaled doses of ETD001 on percent predicted forced expiratory (Part B) volume in 1 second (ppFEV1) in pwCF, compared to placebo. Until now we included 2 pt., plan to include 1-2 more. | 01.07.24 | 01.04.25 | |||
| 51.000 | Allergies related to Cystic Fibrosis (ART-CF) | Allergies related to Cystic Fibrosis (ART-CF) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner | Recruiting | Observational | DZL recruiting center, DZL Investigator Initiated Trial | Externally - public | An observational study in which the reactions of drugs already approved and in use for the treatment of CF are to be investigated. | An observational study in which the reactions of drugs already approved and in use for the treatment of CF are to be investigated. | 07.09.20 | 31.08.25 | |||||
| 51.018 | Aufbau einer Bio- und DNA-Bank mit Register bei Patienten mit Mukoviszidose | Aufbau einer Bio- und DNA-Bank mit Register bei Patienten mit Mukoviszidose | CFBE | Cystic Fibrosis | ARCN, BREATH, TLRC, BIH / Charité - Associated Partner, UGMLC | Recruiting | Observational | DZL recruiting center, DZL Investigator Initiated Trial, DZL discovery-based | DZL | Diese drei übergeordneten Ziele (Identifikation krankheitsmodifizierender Gene, neuer CF-Pathogene sowie neuer Biomarker) sollen dazu dienen 1. neue therapeutische Angriffspunkte zu bestimmen 2. die Diagnostik zu verbessern 3. die Krankheitsaktivität und den –verlauf zu überwachen 4. und das Ansprechen auf eine Therapie zu überprüfen. Dies kann gelingen, wenn krankheitsmodifizierende Gene, neue CF-Pathogene und/oder neue Biomarker mit dem Krankheitsverlauf einer großen Kohorte korreliert werden. Hierzu soll das Register genutzt werden, das die wesentlichen Parameter des Krankheitsverlaufs der Patienten beinhaltet. | Diese drei übergeordneten Ziele (Identifikation krankheitsmodifizierender Gene, neuer CF-Pathogene sowie neuer Biomarker) sollen dazu dienen 1. neue therapeutische Angriffspunkte zu bestimmen 2. die Diagnostik zu verbessern 3. die Krankheitsaktivität und den –verlauf zu überwachen 4. und das Ansprechen auf eine Therapie zu überprüfen. Dies kann gelingen, wenn krankheitsmodifizierende Gene, neue CF-Pathogene und/oder neue Biomarker mit dem Krankheitsverlauf einer großen Kohorte korreliert werden. Hierzu soll das Register genutzt werden, das die wesentlichen Parameter des Krankheitsverlaufs der Patienten beinhaltet. | 21.02.17 | 31.12.35 | |||||
| 51.047 | COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF | COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF | CFBE | Cystic Fibrosis | BREATH, CPC-M, UGMLC | Closed | NCT05012306 | 2021-003277-55 | NCT05012306, 2021-003277-55 | Observational | DZL recruiting center | Externally - public | This study collects blood samples from thousands of people with CF to see whether the person had a previous SARS-CoV-2 infection. The study also explores the level of antibodies to SARS-CoV-2 after vaccination or after infection, and how they change over time. | This study collects blood samples from thousands of people with CF to see whether the person had a previous SARS-CoV-2 infection. The study also explores the level of antibodies to SARS-CoV-2 after vaccination or after infection, and how they change over time. | 23.11.21 | 24.02.25 | ||
| 51.135 | Open-label single-arm, multicenter clinical trial to evaluate patient acceptability of a new CREON formulation of Pancreas Powder gastro-resistant pellets in patients with cystic fibrosis suffering from pancreatic exocrine insufficiency. (PANC-GRP-3001) | Open-label single-arm, multicenter clinical trial to evaluate patient acceptability of a new CREON formulation of Pancreas Powder gastro-resistant pellets in patients with cystic fibrosis suffering from pancreatic exocrine insufficiency. (PANC-GRP-3001) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, CPC-M, TLRC | Closed | 2023-503256-27-00 | 2023-503256-27-00 | Interventional | DZL recruiting center | Externally - industry | The primary objective of the study is the Evaluation of acceptability of a new CREON sachet formulation containing Pancreas Powder gastro-resistant pellets for oral suspension. We included 11 patients, no drop out. | The primary objective of the study is the Evaluation of acceptability of a new CREON sachet formulation containing Pancreas Powder gastro-resistant pellets for oral suspension. We included 11 patients, no drop out. | 01.06.24 | 31.12.24 | |||
| 50.897 | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. | PH | CTEPH - chronic thromboembolic pulmonary hypertension | BREATH | Closed | 2018-002823-41 | 2018-002823-41 | Interventional | DZL recruiting center | Externally - industry | The primary objective of the study is to evaluate the effect of selexipag on PVR versus placebo in subjects with inoperable CTEPH (ie, technically non-operable) and persistent/recurrent CTEPH after surgical (PEA) and/or interventional (BPA) treatment at Week 20. | The primary objective of the study is to evaluate the effect of selexipag on PVR versus placebo in subjects with inoperable CTEPH (ie, technically non-operable) and persistent/recurrent CTEPH after surgical (PEA) and/or interventional (BPA) treatment at Week 20. | 28.11.19 | 14.07.22 | |||
| 50.901 | A MULTINATIONAL, PHASE 2, RANDOMISED, ADAPTIVE PROTOCOL TO EVALUATE IMMUNOGENICITY AND REACTOGENICITY OF DIFFERENT COVID-19 VACCINES ADMINISTRATION IN OLDER ADULTS (≥75) ALREADY VACCINATED AGAINST SARS-COV-2 (EU-COVAT-1_AGED) | A MULTINATIONAL, PHASE 2, RANDOMISED, ADAPTIVE PROTOCOL TO EVALUATE IMMUNOGENICITY AND REACTOGENICITY OF DIFFERENT COVID-19 VACCINES ADMINISTRATION IN OLDER ADULTS (≥75) ALREADY VACCINATED AGAINST SARS-COV-2 (EU-COVAT-1_AGED) | PALI | COVID-19 | BREATH | Closed | 2021-004526-29 | 2021-004526-29 | Interventional | DZL recruiting center | Externally - public | Rate of 2-fold antibody titre increase 14 days after a 4th vaccination dose measured by quantitative enzyme-linked immunosorbent assay (Anti- RBD-ELISA) against wildtype virus. | Rate of 2-fold antibody titre increase 14 days after a 4th vaccination dose measured by quantitative enzyme-linked immunosorbent assay (Anti- RBD-ELISA) against wildtype virus. | 08.07.22 | 01.12.23 | |||
| 50.915 | A phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexa-caftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Sub-jects with Non-F508del CFTR Genotypes (VX21-445-125) | A phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexa-caftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Sub-jects with Non-F508del CFTR Genotypes (VX21-445-125) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, UGMLC, BREATH, CPC-M | Active / not recruiting | NCT05331183 | 2021-005914-33 | NCT05331183, 2021-005914-33 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation. | This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation. | 01.11.22 | 30.04.27 | ||
| 50.921 | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) (VX18-445-110) | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) (VX18-445-110) | CFBE | Cystic Fibrosis | UGMLC | Closed | NCT04058366 | 2019-000833-37 | NCT04058366, 2019-000833-37 | Interventional | DZL recruiting center | Externally - industry | This study evaluated the long-term safety, efficacy, and pharmaco-dynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes). | This study evaluated the long-term safety, efficacy, and pharmaco-dynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes). | 01.12.19 | 01.12.22 | ||
| 50.922 | A Phase 3, open-label study evaluating the long-term safety and efficacy of VX-445 combination therapy in subjects with cystic fibrosis who are homozygous or heterozygous for the F508del mutation (VX17-445-105) | A Phase 3, open-label study evaluating the long-term safety and efficacy of VX-445 combination therapy in subjects with cystic fibrosis who are homozygous or heterozygous for the F508del mutation (VX17-445-105) | CFBE | Cystic Fibrosis | UGMLC | Closed | NCT03525574 | 2018-000185-11 | NCT03525574, 2018-000185-11 | Interventional | DZL recruiting center | Externally - industry | The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozy-gous for the F508del mutation. | The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozy-gous for the F508del mutation. | 01.10.18 | 01.01.23 | ||
| 50.923 | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation (VX17-659-105) | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation (VX17-659-105) | CFBE | Cystic Fibrosis | ARCN, BREATH, CPC-M, BIH / Charité - Associated Partner | Terminated | NCT03447262 | 2017-004134-29 | NCT03447262, 2017-004134-29 | Interventional | DZL recruiting center | Externally - industry | This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation. | This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation. | 13.11.18 | 04.02.21 | ||
| 50.924 | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (VX18-445-113) | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (VX18-445-113) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, ARCN, BREATH, CPC-M | Closed | NCT04043806 | 2018-004652-38 | NCT04043806, 2018-004652-38 | Interventional | DZL recruiting center | Externally - industry | This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF). | This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF). | 12.12.19 | 25.10.22 | ||
| 50.928 | A Phase 3, open-label, rollover study to evaluate the safety and efficacy of long-term treatment with tezacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 years and old-er, homozygous or heterozygous for the F508del-CFTR mutation (VX17-661-116) | A Phase 3, open-label, rollover study to evaluate the safety and efficacy of long-term treatment with tezacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 years and old-er, homozygous or heterozygous for the F508del-CFTR mutation (VX17-661-116) | CFBE | Cystic Fibrosis | BREATH, UGMLC | Closed | NCT03537651 | 2017-002968-40 | NCT03537651, 2017-002968-40 | Interventional | DZL recruiting center | Externally - industry | This study evaluates the long-term safety and tolerability of te-zacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozy-gous for the F508del mutation. | This study evaluates the long-term safety and tolerability of te-zacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozy-gous for the F508del mutation. | 01.04.18 | 01.09.23 | ||
| 50.936 | A Phase 3b, Randomized, Placebo-controlle Study Evaluating the Efficacy and Safety of Elexa-caftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Sub-jects 6 Through 11 Years of Age Who Are Hetero-zygous for the F508del Mutation and a Minimal Function Mutation (F/MF) (VX19-445-116) | A Phase 3b, Randomized, Placebo-controlle Study Evaluating the Efficacy and Safety of Elexa-caftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Sub-jects 6 Through 11 Years of Age Who Are Hetero-zygous for the F508del Mutation and a Minimal Function Mutation (F/MF) (VX19-445-116) | CFBE | Cystic Fibrosis | BIH / Charité - Associated Partner, UGMLC, TLRC, BREATH | Closed | NCT04353817 | 2019-003554-86 | NCT04353817, 2019-003554-86 | Interventional | DZL recruiting center | Externally - industry | This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozy-gous for F508del and a minimal function (MF) mutation (F/MF genotypes). | This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozy-gous for F508del and a minimal function (MF) mutation (F/MF genotypes). | 01.06.20 | 20.07.21 | ||
| 51.005 | An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Pro-gression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Pro-gression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | CFBE | Cystic Fibrosis | ARCN, BREATH, TLRC, UGMLC, BIH / Charité - Associated Partner | Closed | NCT03625466 | 2017-003761-99 | NCT03625466, 2017-003761-99 | Interventional | DZL on steering board, DZL recruiting center | Externally - industry | This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F). | This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F). | 01.08.18 | 01.09.23 | ||
| 51.035 | Change-MRI (CTEPH Diagnosis Europe - MRI) | Change-MRI (CTEPH Diagnosis Europe - MRI) | PH | CTEPH - chronic thromboembolic pulmonary hypertension | BREATH, TLRC | Active / not recruiting | NCT02791282 | NCT02791282 | Observational | DZL discovery-based | Externally - public | The aim of the study CHANGE-MRI is to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CPA). | The aim of the study CHANGE-MRI is to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CPA). | 01.06.16 | 30.06.25 | |||
| 51.072 | Evaluation eines Früherkennungsverfahrens zur Diagnostik pulmonaler Beteiligungen bei rheumatologischen Grunderkrankungen | Evaluation eines Früherkennungsverfahrens zur Diagnostik pulmonaler Beteiligungen bei rheumatologischen Grunderkrankungen | DPLD | CTD-ILD | CPC-M | Closed | Observational | DZL recruiting center, DZL Investigator Initiated Trial | Externally - public | Ein Früherkennungsprogramm kann die Diagnosestellung und somit auch Prognose der pneumologischen Beteiligung bei rheumatologischen Erkrankungen verbessern. | Ein Früherkennungsprogramm kann die Diagnosestellung und somit auch Prognose der pneumologischen Beteiligung bei rheumatologischen Erkrankungen verbessern. | 06.03.23 | 30.04.24 | |||||
| 51.083 | Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID) | Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID) | PALI | COVID-19 pneumonia | BREATH, TLRC, UGMLC | Closed | NCT04569877 | 2020-001654-21 | NCT04569877, 2020-001654-21 | Interventional | DZL discovery-based, DZL on steering board | Externally - industry | COVID-19 pneumonia is induced by the newly emerging pandemic Severe acute respiratory Syndrome (SARS) coronavirus 2 and results in progression to the acute respiratory distress syndrome (ARDS). Apart from protective ventilation, fluid restriction, prone positioning and extracorporeal membrane oxygenation (ECMO), no specific therapeutic options exist to treat this devastating disease with a mortality rate of up to 50%. The growth factor granulocyte-macrophage colony-stimulating factor (GM-CSF) is widely recognized to promote differentiation and mobilization of different myeloid leukocyte subsets including neutrophils, tissue macrophages/dendritic cells or their circulating precursors. GM-CSF was found to be crucial for alveolar epithelial repair following hyperoxic and inflammatory lung injury.The aim of the current trial is to prevent progression to ARDS in COVID-19 pneumonia patients by preemptive GM-CSF Inhalation | COVID-19 pneumonia is induced by the newly emerging pandemic Severe acute respiratory Syndrome (SARS) coronavirus 2 and results in progression to the acute respiratory distress syndrome (ARDS). Apart from protective ventilation, fluid restriction, prone positioning and extracorporeal membrane oxygenation (ECMO), no specific therapeutic options exist to treat this devastating disease with a mortality rate of up to 50%. The growth factor granulocyte-macrophage colony-stimulating factor (GM-CSF) is widely recognized to promote differentiation and mobilization of different myeloid leukocyte subsets including neutrophils, tissue macrophages/dendritic cells or their circulating precursors. GM-CSF was found to be crucial for alveolar epithelial repair following hyperoxic and inflammatory lung injury.The aim of the current trial is to prevent progression to ARDS in COVID-19 pneumonia patients by preemptive GM-CSF Inhalation | 24.09.20 | 20.09.22 | ||
| 51.084 | Hamburg Edoxaban foR anticoagulation in COvid-19 study | Hamburg Edoxaban foR anticoagulation in COvid-19 study | PALI | COVID-19 | BREATH | Closed | 2020-002504-39 | 2020-002504-39 | Interventional | DZL recruiting center | Externally - public | To evaluate if an intensive anticoagulation strategy using Edoxaban on top of standard of care (SOC) of COVID-19 therapy is superior to SOC (in-hospital moderate anticoagulation strategy = low-dose low-molecular weight heparin [LMWH] / Fondaparinux, ambulatory no anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality end-points in patients with COVID-19 | To evaluate if an intensive anticoagulation strategy using Edoxaban on top of standard of care (SOC) of COVID-19 therapy is superior to SOC (in-hospital moderate anticoagulation strategy = low-dose low-molecular weight heparin [LMWH] / Fondaparinux, ambulatory no anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality end-points in patients with COVID-19 | 27.11.20 | 01.07.24 | |||
| 51.127 | NAPKON-POP | NAPKON-POP | PALI | COVID-19 | BIH / Charité - Associated Partner | Closed | Interventional | DZL recruiting center | Externally - public | In der NAPKON-POP / COVIDOM-Studie wurden Personen aus Berlin, die sich vor mindestens 6 oder mehr Monaten mit dem neuen Coronavirus infiziert hatten, zu ihrem aktuellen Gesundheitszustand und möglichen Beschwerden seit der Infektion befragt. Dabei sind auch Personen, deren Infektion mit SARS-CoV-2 milde oder ohne Beschwerden verlief, von großem Interesse für uns, um die Auswirkungen dieses neuen Virus besser zu verstehen. Über das Gesundheitsamt Neukölln wurden alle Personen, die im passenden Zeitraum ein passendes PCR-Ergebnis auf eine Sars-CoV2-Infektion hatten, zur Studienteilnahme eingeladen. Im Jahr 2021 wurden 302 Teilnehmer eingeschlossen und untersucht, im Jahr 2022 erfolgte eine erneute Rekrutierung von weiteren Teilnehmern sowie die erste Folgeuntersuchung. Seit 2023 laufen die erste und zweite Folgeuntersuchung. Ende der Studie ist der 31.12.204. | In der NAPKON-POP / COVIDOM-Studie wurden Personen aus Berlin, die sich vor mindestens 6 oder mehr Monaten mit dem neuen Coronavirus infiziert hatten, zu ihrem aktuellen Gesundheitszustand und möglichen Beschwerden seit der Infektion befragt. Dabei sind auch Personen, deren Infektion mit SARS-CoV-2 milde oder ohne Beschwerden verlief, von großem Interesse für uns, um die Auswirkungen dieses neuen Virus besser zu verstehen. Über das Gesundheitsamt Neukölln wurden alle Personen, die im passenden Zeitraum ein passendes PCR-Ergebnis auf eine Sars-CoV2-Infektion hatten, zur Studienteilnahme eingeladen. Im Jahr 2021 wurden 302 Teilnehmer eingeschlossen und untersucht, im Jahr 2022 erfolgte eine erneute Rekrutierung von weiteren Teilnehmern sowie die erste Folgeuntersuchung. Seit 2023 laufen die erste und zweite Folgeuntersuchung. Ende der Studie ist der 31.12.204. | 01.10.20 | 31.12.24 | |||||
| 51.131 | Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias (COVIM) | Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias (COVIM) | PALI | COVID-19 pneumonia | BREATH, UGMLC, BIH / Charité - Associated Partner | Closed | NCT04416438 | 2021-001512-28 | NCT04416438, 2021-001512-28 | Observational | DZL discovery-based, DZL on steering board | Externally - industry | The classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000 patients followed in France. Due to the median age of patients around 65, the frequency of cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive treatments on immune cells, these patients are considered to be at risk of developing forms severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a severe form of COVID-19, identify new risk factors linked to the disease as well as the impact of treatments for MNPs according to their pharmacological class. | The classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000 patients followed in France. Due to the median age of patients around 65, the frequency of cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive treatments on immune cells, these patients are considered to be at risk of developing forms severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a severe form of COVID-19, identify new risk factors linked to the disease as well as the impact of treatments for MNPs according to their pharmacological class. | 18.05.18 | 01.09.22 | ||
| 51.142 | Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients | Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients | PALI | COVID-19 | BREATH | Closed | 2020‐005305‐54 | 2020‐005305‐54 | Interventional | DZL recruiting center | Externally - industry | To compare the proportion of participants alive and respiratory failure free during the 28 days after dosing with CPI-006 plus SOC versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection | To compare the proportion of participants alive and respiratory failure free during the 28 days after dosing with CPI-006 plus SOC versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection | 31.05.21 | 01.09.21 | |||
| 51.143 | Phase III Double-blind, Placebo-controlled Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults | Phase III Double-blind, Placebo-controlled Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults | PALI | COVID-19 | BREATH | Closed | 2020-005315-44 | 2020-005315-44 | Interventional | DZL recruiting center | Externally - industry | To estimate the efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29 | To estimate the efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29 | 26.02.21 | 10.03.23 | |||
| 51.154 | RAPID_REVIVE | RAPID_REVIVE | PALI | COVID-19 | BIH / Charité - Associated Partner | Recruiting | 2024-511628-16-00 | 2024-511628-16-00 | Interventional | DZL recruiting center | Externally - public | Randomized adaptive assessment of post COVID syndrome treatments_Reducing Inflammatory Activity in Patients with post COVID Syndrome | Randomized adaptive assessment of post COVID syndrome treatments_Reducing Inflammatory Activity in Patients with post COVID Syndrome | 07.11.24 | 31.12.25 | |||
| 51.369 | Swarm Learning für Präzisionsmedizin bei Infektionskrankheiten und in der Pandemievorsorge (SL-Studie) | Swarm Learning für Präzisionsmedizin bei Infektionskrankheiten und in der Pandemievorsorge (SL-Studie) | PALI | COVID-19 | UGMLC, BIH / Charité - Associated Partner | Not yet recruiting | Observational | DZL recruiting center | Externally - public | As part of a prospective, multicenter study, immunity to SARS-CoV-2 infections in vaccinated individuals will be investigated. Clinical, virological, and immunological data will be collected, standardized, integrated, and analyzed using swarm AI, in comparison with large existing datasets on primary SARS-CoV-2 infections from previous infection waves, which were created and jointly analyzed by members of the consortium. Our goal is to understand the fundamentals of the interaction between host and pathogen in the context of SARS-CoV-2 immunity. | As part of a prospective, multicenter study, immunity to SARS-CoV-2 infections in vaccinated individuals will be investigated. Clinical, virological, and immunological data will be collected, standardized, integrated, and analyzed using swarm AI, in comparison with large existing datasets on primary SARS-CoV-2 infections from previous infection waves, which were created and jointly analyzed by members of the consortium. Our goal is to understand the fundamentals of the interaction between host and pathogen in the context of SARS-CoV-2 immunity. | 01.06.24 | 31.05.26 | |||||
| 50.954 | A prospective, randomized, open label Phase 2 clinical trial to evaluate superiority of anti-SARS-CoV-2 convalescent plasma versus standard-of-care in hospitalized pa-tients with mild COVID-19 | A prospective, randomized, open label Phase 2 clinical trial to evaluate superiority of anti-SARS-CoV-2 convalescent plasma versus standard-of-care in hospitalized pa-tients with mild COVID-19 | PALI | COVID-19 | BREATH | Closed | 2020-001936-86 | 2020-001936-86 | Interventional | DZL recruiting center | Externally - industry | To assess the efficacy of convalescent plasma for the treatment of hospitalized patients with mild COVID-19 infection | To assess the efficacy of convalescent plasma for the treatment of hospitalized patients with mild COVID-19 infection | 17.11.20 | 01.11.21 | |||
| 50.971 | A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease. | A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease. | PALI | COVID-19 | BREATH | Closed | 2020-001759-42 | 2020-001759-42 | Interventional | DZL recruiting center | Externally - industry | To compare the efficacy of otilimab 90 mg IV versus placebo | To compare the efficacy of otilimab 90 mg IV versus placebo | 30.04.21 | 01.07.21 | |||
| 51.042 | CONVERT I | CONVERT I | COPD | COPD | BIH / Charité - Associated Partner | Closed | NCT04559464 | NCT04559464 | Interventional | DZL recruiting center | Externally - industry | Fissurenverschluss mit AeriSeal für die Behandlung von Patienten mit einer fortgeschrittenen COPD mit Ventilen | Fissurenverschluss mit AeriSeal für die Behandlung von Patienten mit einer fortgeschrittenen COPD mit Ventilen | 01.02.21 | 31.01.25 | |||
| 51.044 | COSYCONET 1.0 | COSYCONET 1.0 | COPD | COPD | ARCN | Closed | NCT01245933 | NCT01245933 | Observational | DZL recruiting center | Externally - public | Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD (COSYCONET) | Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD (COSYCONET) | 01.11.22 | 01.12.23 | |||
| 51.058 | Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training | Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training | COPD | COPD & ILD | UGMLC | Recruiting | NCT06545851 | NCT06545851 | Interventional | DZL recruiting center | Externally - public | Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea. Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow. The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training. | Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea. Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow. The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training. | 14.08.23 | 01.04.25 | |||
| 51.060 | Effekte einer Smartphone-Applikation (Kaia COPD) zur selbstgerichteten pneumologischen Rehabilitation symptomatischer COPD-Patienten im häuslichen Umfeld - eine randomisierte, kontrollierte multizentrische und internationale klinische Studie | Effekte einer Smartphone-Applikation (Kaia COPD) zur selbstgerichteten pneumologischen Rehabilitation symptomatischer COPD-Patienten im häuslichen Umfeld - eine randomisierte, kontrollierte multizentrische und internationale klinische Studie | COPD | COPD | UGMLC | Closed | DRKS00024390 | DRKS00024390 | Interventional | DZL recruiting center | Externally - industry | Mit dieser Studie soll der Effekt den Effekt einer digitalen Rehabilitationslösung für Patienten mit symptomatischer COPD auf die körperliche Leistungsfähigkeit (gemessen mittels 1MSTS) und auf die gesundheitsbezogene Lebensqualität (gemessen mittels CAT) bei Patienten mit COPD innerhalb eines Zeitraums von 90 Tagen zu evaluieren. Hierbei wird die Veränderung in der Anzahl der Wiederholungen im 1MSTS sowie die Veränderung im CAT-Score vom Ausgangswert im Vergleich zur Kontrollgruppe (Standardbehandlung) evaluiert. | Mit dieser Studie soll der Effekt den Effekt einer digitalen Rehabilitationslösung für Patienten mit symptomatischer COPD auf die körperliche Leistungsfähigkeit (gemessen mittels 1MSTS) und auf die gesundheitsbezogene Lebensqualität (gemessen mittels CAT) bei Patienten mit COPD innerhalb eines Zeitraums von 90 Tagen zu evaluieren. Hierbei wird die Veränderung in der Anzahl der Wiederholungen im 1MSTS sowie die Veränderung im CAT-Score vom Ausgangswert im Vergleich zur Kontrollgruppe (Standardbehandlung) evaluiert. | 26.05.21 | 22.05.23 | |||
| 51.064 | Einfluss systemischer Manifestation und Komorbiditäten auf den klinischen Zustand und Verlauf bei Patienten mit COPD (COSYCONET 2) | Einfluss systemischer Manifestation und Komorbiditäten auf den klinischen Zustand und Verlauf bei Patienten mit COPD (COSYCONET 2) | COPD | COPD | UGMLC | Closed | DRKS00015884 | DRKS00015884 | Observational | DZL recruiting center | Externally - industry | The aim of this study is to investigate the relationship between pulmonary disorders, comorbidities, and systemic inflammation in patients with COPD, both cross-sectionally and longitudinally. Of particular interest is the course of the disease in mild stages of COPD. The study is based on the results and methods of the COSYCONET 1 study and aims at creating a modified study protocol, while at the same time ensuring comparability. | The aim of this study is to investigate the relationship between pulmonary disorders, comorbidities, and systemic inflammation in patients with COPD, both cross-sectionally and longitudinally. Of particular interest is the course of the disease in mild stages of COPD. The study is based on the results and methods of the COSYCONET 1 study and aims at creating a modified study protocol, while at the same time ensuring comparability. | 04.11.19 | 31.03.28 | |||
| 51.086 | IMPL-AI-MENT | IMPL-AI-MENT | COPD | COPD | BIH / Charité - Associated Partner | Recruiting | NCT06410547 | NCT06410547 | Interventional | DZL recruiting center | Externally - public | LLM-Randomisierte Studie zur Überprüfung der leitliniengerechten Therpaie | LLM-Randomisierte Studie zur Überprüfung der leitliniengerechten Therpaie | 01.06.24 | 31.12.24 | |||
| 51.097 | KAIA COPD 002: Kaia COPD-App for Self-Management of Symptomatic COPD through Digital Delivery of multimodal PR Program (KOALA) | KAIA COPD 002: Kaia COPD-App for Self-Management of Symptomatic COPD through Digital Delivery of multimodal PR Program (KOALA) | COPD | COPD | UGMLC | Closed | Interventional | DZL recruiting center | Externally - industry | The primary objective of the study is to assess the effect of the intervention by the KAIA app on physical exercise capacity and health-related quality of life in patients with COPD over 12 weeks as measured by comparing the change in number of repetitions and change in the COPD Assessment Test score, from baseline, in comparison to the usual-care group. | The primary objective of the study is to assess the effect of the intervention by the KAIA app on physical exercise capacity and health-related quality of life in patients with COPD over 12 weeks as measured by comparing the change in number of repetitions and change in the COPD Assessment Test score, from baseline, in comparison to the usual-care group. | 01.05.21 | 30.11.23 | |||||
| 51.112 | Lung emphysema Register | Lung emphysema Register | COPD | COPD | BIH / Charité - Associated Partner | Recruiting | DRKS00021207 | DRKS00021207 | Observational | DZL recruiting center | Externally - public | Herstellerunabhängiges und intersektorales Register für die Therapie von COPD-Patient*innen mit schwerem Lungenemphysem | Herstellerunabhängiges und intersektorales Register für die Therapie von COPD-Patient*innen mit schwerem Lungenemphysem | 01.01.18 | 31.12.38 | |||
| 51.147 | Prädiktoren einer akuten Exazerbation bei COPD Patienten – eine Beobachtungsstudie (PACE-Trial) | Prädiktoren einer akuten Exazerbation bei COPD Patienten – eine Beobachtungsstudie (PACE-Trial) | COPD | COPD | UGMLC | Closed | NCT04140097 | NCT04140097 | Observational | DZL recruiting center | Externally - industry | Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by respiratory problems and poor airflow with dyspnea and cough being the main symptoms. Acute exacerbations of COPD (AECOPD) are the most important events for patients with COPD that have a negative impact on patients´ quality of life, accelerate disease progression, and can result in hospital admissions and death. It is of major clinical importance to determine predictors of an AECOPD and to identify patients who are at high risk for developing an acute exacerbation and/or to detect the beginning of or prevent an ongoing acute exacerbation as early as possible. Until now, research in the field of AECOPD has gathered and analyzed data only after manifestation of AECOPD until recovery and most of them used a retrospective study design. Therefore, the aim of this prospective trial is to collect clinical data in patients prior to the first visible clinical signs of an AECOPD to investigate potential early predictors of an AECOPD. | Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by respiratory problems and poor airflow with dyspnea and cough being the main symptoms. Acute exacerbations of COPD (AECOPD) are the most important events for patients with COPD that have a negative impact on patients´ quality of life, accelerate disease progression, and can result in hospital admissions and death. It is of major clinical importance to determine predictors of an AECOPD and to identify patients who are at high risk for developing an acute exacerbation and/or to detect the beginning of or prevent an ongoing acute exacerbation as early as possible. Until now, research in the field of AECOPD has gathered and analyzed data only after manifestation of AECOPD until recovery and most of them used a retrospective study design. Therefore, the aim of this prospective trial is to collect clinical data in patients prior to the first visible clinical signs of an AECOPD to investigate potential early predictors of an AECOPD. | 26.02.20 | 30.04.24 | |||
| 51.158 | RESPIRE - ATR-002-002 | RESPIRE - ATR-002-002 | PALI | COVID-19 | BIH / Charité - Associated Partner | Closed | NCT04776044 | 2020-004206-59 | NCT04776044, 2020-004206-59 | Interventional | DZL recruiting center | Externally - industry | Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an Intensive Care Unit (ICU) is associated with substantial mortality. All patients with severe pneumonia who are treated in an ICU will receive therapy that consist | Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an Intensive Care Unit (ICU) is associated with substantial mortality. All patients with severe pneumonia who are treated in an ICU will receive therapy that consist | 12.04.21 | 11.10.22 | ||
| 51.159 | Rhesolve | Rhesolve | COPD | COPD | BIH / Charité - Associated Partner | Closed | NCT04677465 | NCT04677465 | Interventional | DZL recruiting center | Externally - industry | Eine klinische Bewertung des RheOx-Bronchial-Rheoplastiksystems zur Behandlung der Symptome chronischer Bronchitis bei erwachsenen Patienten mit COPD | Eine klinische Bewertung des RheOx-Bronchial-Rheoplastiksystems zur Behandlung der Symptome chronischer Bronchitis bei erwachsenen Patienten mit COPD | 01.01.22 | 01.01.25 | |||
| 51.184 | Triple thErapy in paTients with COPD under Real lIve Setting (the TETRIS study) | Triple thErapy in paTients with COPD under Real lIve Setting (the TETRIS study) | COPD | COPD | BREATH | Closed | Interventional | DZL recruiting center | Externally - industry | The primary objective is to describe the percentage of participants with diagnosed COPD with or without comorbid asthma (hereinafter summarized as COPD*) who continuously receive triple therapy for 6, 12 and 24 months after study enrolment. | The primary objective is to describe the percentage of participants with diagnosed COPD with or without comorbid asthma (hereinafter summarized as COPD*) who continuously receive triple therapy for 6, 12 and 24 months after study enrolment. | 28.09.21 | 02.10.24 | |||||
| 51.363 | Clinical Trial Comparing the Pharmacological Effects of EP395 With Placebo in Healthy Adults | Clinical Trial Comparing the Pharmacological Effects of EP395 With Placebo in Healthy Adults | COPD | COPD | BREATH | Closed | NCT05516316 | NCT05516316 | Interventional | DZL recruiting center | Externally - industry | This study aims to assess the effect of EP395 against an induced inflammation of the lung. In addition, further data about the safety and tolerability of EP395 will be collected. To investigate the efficacy of EP395 at the end of the treatment with EP395 or placebo (dummy), all participants will inhale a lipopolysaccharide (a molecule composed of sugar and fat) that artificially induces an acute inflammation of the airways. It is assumed that participants who received EP395 will show less inflammation of the airways than participants who received placebo. | This study aims to assess the effect of EP395 against an induced inflammation of the lung. In addition, further data about the safety and tolerability of EP395 will be collected. To investigate the efficacy of EP395 at the end of the treatment with EP395 or placebo (dummy), all participants will inhale a lipopolysaccharide (a molecule composed of sugar and fat) that artificially induces an acute inflammation of the airways. It is assumed that participants who received EP395 will show less inflammation of the airways than participants who received placebo. | 01.01.22 | 31.12.23 | |||
| 51.364 | Clinical Trial Investigating the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults | Clinical Trial Investigating the Effects of EP395 Following an Inhaled Endotoxin Challenge in Healthy Adults | COPD | COPD | BREATH | Recruiting | NCT06677918 | NCT06677918 | Interventional | DZL recruiting center | Externally - industry | The aim of this clinical trial is to assess the effect of EP395 in a model of lung inflammation (inhaled lipopolysaccharide, which causes temporary inflammation in the airways). In addition, further information on the safety and tolerability of EP395 will be collected. | The aim of this clinical trial is to assess the effect of EP395 in a model of lung inflammation (inhaled lipopolysaccharide, which causes temporary inflammation in the airways). In addition, further information on the safety and tolerability of EP395 will be collected. | 20.02.25 | 30.06.26 | |||
| 51.365 | Effects of CSL324 in the Lung After Segmental Challenge | Effects of CSL324 in the Lung After Segmental Challenge | COPD | COPD | BREATH | Closed | NCT05653713 | NCT05653713 | Interventional | DZL recruiting center | Externally - industry | This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in a single lung segment. Saline will be instilled into a segment in the contralateral lung for the purpose of comparison. | This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in a single lung segment. Saline will be instilled into a segment in the contralateral lung for the purpose of comparison. | 01.08.22 | 31.12.23 | |||
| 51.366 | Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD (AERIFY-3) | Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD (AERIFY-3) | COPD | COPD | BREATH | Active / not recruiting | NCT05326412 | NCT05326412 | Interventional | DZL recruiting center | Externally - industry | This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). Part A will consist of participants who are former smokers with COPD; Part B will consist of participants who are current smokers with COPD. | This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). Part A will consist of participants who are former smokers with COPD; Part B will consist of participants who are current smokers with COPD. | 19.05.22 | 24.03.25 | |||
| 51.367 | Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers. (AMIR-21) | Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers. (AMIR-21) | COPD | COPD | BREATH | Recruiting | NCT06752122 | NCT06752122 | Interventional | DZL recruiting center | Externally - industry | The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single or multiple doses of RCS-21 for a maximum of 7 days and their health status will be constantly monitored. | The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single or multiple doses of RCS-21 for a maximum of 7 days and their health status will be constantly monitored. | 18.02.25 | 31.03.26 | |||
| 51.368 | Use of Exhaled Particles to Assess Lung Pharmacokinetics (EXPLORE) | Use of Exhaled Particles to Assess Lung Pharmacokinetics (EXPLORE) | COPD | COPD | BREATH | Closed | NCT04914273 | NCT04914273 | Interventional | DZL recruiting center | DZL | This research project in humans aims at increasing the general understanding of lung pharmakokinetic by sampling exhaled particles. The central hypothesis of this study is that pharmacokinetics of Salbutamol (model drug) can be monitored in exhaled particles. | This research project in humans aims at increasing the general understanding of lung pharmakokinetic by sampling exhaled particles. The central hypothesis of this study is that pharmacokinetics of Salbutamol (model drug) can be monitored in exhaled particles. | 14.06.21 | 03.08.21 | |||
| 50.896 | A multi-center, randomized, double-blind, parallel-group, placebocontrolled study of mepolizumab 100 mg SC as add-on treatment in participants with COPD experiencing frequency exacerbations and characterized by eosinophil levels (Study 208657) | A multi-center, randomized, double-blind, parallel-group, placebocontrolled study of mepolizumab 100 mg SC as add-on treatment in participants with COPD experiencing frequency exacerbations and characterized by eosinophil levels (Study 208657) | AA | COPD | BREATH | Closed | 2018-001540-56 | 2018-001540-56 | Interventional | DZL recruiting center | Externally - industry | To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk of exacerbations despite the use of optimized COPD maintenance therapy. | To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk of exacerbations despite the use of optimized COPD maintenance therapy. | 09.03.23 | 30.09.23 | |||
| 50.942 | A phase IIB, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Astegolimab in patients with chronic obstructive pulmonary disease (Aliento) | A phase IIB, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Astegolimab in patients with chronic obstructive pulmonary disease (Aliento) | COPD | COPD | UGMLC | Recruiting | NCT05037929 | 2023-507093-40-00 | NCT05037929, 2023-507093-40-00 | Interventional | DZL recruiting center | Externally - industry | The primary objective of this study is to evalu-ate the efficacy of astegolimab compared with placebo in patients with COPD judged by the annualized rate of moderate and severe COPD exacerbations during the 52-week treatment period. In addition, the change of health-related quality of life during the treatment period, the safety of astegolimab compared with placebo and the immune response to astegolimab are tested. | The primary objective of this study is to evalu-ate the efficacy of astegolimab compared with placebo in patients with COPD judged by the annualized rate of moderate and severe COPD exacerbations during the 52-week treatment period. In addition, the change of health-related quality of life during the treatment period, the safety of astegolimab compared with placebo and the immune response to astegolimab are tested. | 09.12.22 | 30.09.25 | ||
| 50.944 | A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA) | A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA) | COPD | COPD | CPC-M | Closed | NCT05158387 | 2021-003771-34 | NCT05158387, 2021-003771-34 | Interventional | DZL on steering board | Externally - industry | A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA) | A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA) | 01.03.23 | 01.12.24 | ||
| 50.962 | A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS) | A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS) | COPD | COPD | BREATH | Recruiting | NCT06283966 | 2023-507407-59 | NCT06283966, 2023-507407-59 | Interventional | DZL recruiting center | Externally - industry | A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS) | A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS) | 27.09.24 | 31.12.25 | ||
| 50.966 | A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation (BOREAS) | A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation (BOREAS) | COPD | COPD | UGMLC | Closed | NCT03930732 | 2018-001953-28 | NCT03930732, 2018-001953-28 | Interventional | DZL recruiting center | Externally - industry | This study is designed to investigate the effi-cacy (e. g., lung function, prevention of mo-derate and severe exacerbations, symptom control) and safety of dupilumab (300 mg, subcutaneous, q2w) over one year in patients with Type 2 inflammation in addition to their standard of care treatment. | This study is designed to investigate the effi-cacy (e. g., lung function, prevention of mo-derate and severe exacerbations, symptom control) and safety of dupilumab (300 mg, subcutaneous, q2w) over one year in patients with Type 2 inflammation in addition to their standard of care treatment. | 14.10.19 | 06.09.23 | ||
| 50.967 | A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation (NOTUS) | A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation (NOTUS) | COPD | COPD | UGMLC | Closed | NCT04456673 | 2018-001954-91 | NCT04456673, 2018-001954-91 | Interventional | DZL recruiting center | Externally - industry | The primary objective of this study is the evalu¬ation of the efficacy, safety, and tolerability of dupilumab over one year in patients with moderate-to-severe COPD with Type 2 inflammation. Efficacy will be assessed on multiple COPD domains, including lung func¬tion, prevention of moderate and severe exa¬cerbations, and symptom control. | The primary objective of this study is the evalu¬ation of the efficacy, safety, and tolerability of dupilumab over one year in patients with moderate-to-severe COPD with Type 2 inflammation. Efficacy will be assessed on multiple COPD domains, including lung func¬tion, prevention of moderate and severe exa¬cerbations, and symptom control. | 13.10.20 | 29.10.24 | ||
| 50.978 | A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP) | A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP) | PALI | Community acquired pneumonia (CAP) | BREATH | Closed | 2017‐003207‐21 | 2017‐003207‐21 | Interventional | DZL recruiting center | Externally - industry | The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). | The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). | 23.06.23 | 03.07.24 | |||
| 51.013 | AON-D21 | AON-D21 | PALI | Community acquired pneumonia (CAP) | BIH / Charité - Associated Partner | Recruiting | NCT05962606 | 2023-505985-28-00 | NCT05962606, 2023-505985-28-00 | Interventional | DZL recruiting center | Externally - industry | An Exploratory, Multi-Centre, Interventional, Prospective, Randomised, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of AON-D21 in Patients with Severe Community-Acquired Pneumonia | An Exploratory, Multi-Centre, Interventional, Prospective, Randomised, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of AON-D21 in Patients with Severe Community-Acquired Pneumonia | 10.04.24 | 31.12.25 | ||
| 51.021 | BEAR-STUDY: A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho-Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years with Wheezing Lower Respiratory Illness | BEAR-STUDY: A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho-Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years with Wheezing Lower Respiratory Illness | AA, CFBE | Children with recurrent respiratory tract infections associated with wheezing lower respiratory illness | ARCN, BREATH, CPC-M, UGMLC | Recruiting | NCT05677763 | 2022-000886-42 | NCT05677763, 2022-000886-42 | Interventional | DZL recruiting center, DZL discovery-based | Externally - industry | This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years. Detailed Description | This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years. Detailed Description | 03.05.23 | 30.09.26 | ||
| 51.022 | BENTO | BENTO | COPD | COPD | BIH / Charité - Associated Partner | Recruiting | NCT05717192 | NCT05717192 | Interventional | DZL recruiting center | Externally - public | Bronchoskopische Lungenvolumenreduktion bei schwerem Lungenemphysem mittels Thermoablation | Bronchoskopische Lungenvolumenreduktion bei schwerem Lungenemphysem mittels Thermoablation | 01.06.24 | 31.12.26 | |||
| 51.033 | CAPNETZ | CAPNETZ | PALI | Community acquired pneumonia (CAP) | BREATH, ARCN, UGMLC, BIH / Charité - Associated Partner | Recruiting | NCT02139163 | NCT02139163 | Observational | DZL Investigator Initiated Trial | DZL, Externally - industry | The CAPNETZ study is an observational study on community-acquired pneumonia (CAP) in adults. | The CAPNETZ study is an observational study on community-acquired pneumonia (CAP) in adults. | 01.10.02 | 31.12.30 | |||
| 51.141 | Pediatric Airway Pathogen Incident (PAPI) Study | Pediatric Airway Pathogen Incident (PAPI) Study | PALI | Children with lower respiratory tract infections | BREATH | Recruiting | DRKS00026155 | DRKS00026155 | Observational | DZL recruiting center | Externally - industry | The aim of this study is to complement ongoing burden assessment research with prospective surveillance of LRTI hospitalizations attributable to RSV, including the resulting complications and impact on cost-effectiveness. In addition, co-circulating viral pathogens that cause LRTI, such as human metapneumovirus (HMPV) and SARS-Cov2, will be analyzed. | The aim of this study is to complement ongoing burden assessment research with prospective surveillance of LRTI hospitalizations attributable to RSV, including the resulting complications and impact on cost-effectiveness. In addition, co-circulating viral pathogens that cause LRTI, such as human metapneumovirus (HMPV) and SARS-Cov2, will be analyzed. | 21.10.21 | 31.07.25 | |||
| 51.145 | PNEUMO / Biotest 996 ECsCAPE | PNEUMO / Biotest 996 ECsCAPE | PALI | Community acquired pneumonia (CAP) | BIH / Charité - Associated Partner | Recruiting | NCT05722938 | 2022-501352-28-00 | NCT05722938, 2022-501352-28-00 | Interventional | DZL recruiting center | Externally - public | A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP). Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an Intensive Care Unit (ICU) is associated with substantial mortality. All patients with severe pneumonia who are treated in an ICU will receive therapy. | A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP). Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an Intensive Care Unit (ICU) is associated with substantial mortality. All patients with severe pneumonia who are treated in an ICU will receive therapy. | 07.06.23 | 31.12.26 | ||
| 51.149 | Prospektive Beobachtungsstudie zu SARS-CoV2 Infektionen bei Kindern und Jugendlichen (pedCAPNETZ Covid) | Prospektive Beobachtungsstudie zu SARS-CoV2 Infektionen bei Kindern und Jugendlichen (pedCAPNETZ Covid) | DPLD | Children and adolescents with COVID-19 infection | ARCN, BREATH | Closed | Observational | DZL recruiting center | Externally - industry | The aim of the pedCAPNETZ-COVID 19 study is to provide a detailed description of the clinical course of the disease and to identify risk factors such as previous illnesses or specific therapeutic agents as well as prognostic markers. | The aim of the pedCAPNETZ-COVID 19 study is to provide a detailed description of the clinical course of the disease and to identify risk factors such as previous illnesses or specific therapeutic agents as well as prognostic markers. | 01.08.20 | 30.09.22 | |||||
| 51.153 | Randomized, doub le-blind, placebo-controlled, parallelgroup Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) | Randomized, doub le-blind, placebo-controlled, parallelgroup Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) | COPD | COPD | BREATH | Closed | NCT04701983 | 2020-001819-24 | NCT04701983, 2020-001819-24 | Interventional | DZL recruiting center | Externally - industry | Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderateor- severe COPD exacerbations in former smokers with moderate-to-severe COPD | Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderateor- severe COPD exacerbations in former smokers with moderate-to-severe COPD | 26.01.24 | 01.07.24 | ||
| 51.156 | Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19 and other community-acquired pneumonia. A multinational, multicentre, randomised, double-blinded, placebo-controlled, parallel-group phase III trial. (REPAVID-22) | Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19 and other community-acquired pneumonia. A multinational, multicentre, randomised, double-blinded, placebo-controlled, parallel-group phase III trial. (REPAVID-22) | PALI | Community acquired pneumonia (CAP) | BREATH | Closed | 2021-006951-32 | 2021-006951-32 | Interventional | DZL recruiting center | Externally - industry | To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP) (including COVID-19). | To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP) (including COVID-19). | 14.07.23 | 02.05.24 | |||
| 51.359 | A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS | A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS | COPD | COPD | BREATH | Closed | NCT05351671 | NCT05351671 | Interventional | DZL recruiting center | Externally - industry | This is a Phase 1b, randomized, double-blind, placebo-controlled, dose range finding study to assess the safety, tolerability, pharmacodynamics (PK) and pharmacokinetics (PD) of RLS-0071 in healthy adult subjects after challenge with inhaled lipopolysaccharide (LPS). Clinical data are required to determine the potential benefit of RLS-0071, a novel drug that specifically inhibits multiple inflammatory pathways, for the treatment of severe asthma. This study has been designed to evaluate the efficacy of IV administered RLS-0071 to reduce inflammation symptoms in healthy subjects challenged with inhaled LPS, a well-known agent that produces a safe and well-controlled inflammatory response in the lung. This is a critical proof-of-concept study and dose-optimization study for future studies in severe asthma patients. A total of 48 healthy adult subjects are planned to be enrolled in this study. Subjects will be randomly allocated to either of the treatment arms (Arm A or Arm B) with RLS-0071 or the placebo arm (Arm C) in a 1:1:1 ratio. Subjects will either receive intravenous infusion of RLS-0071 at a lower dose every 8 hours for a total of 3 doses (Arm A), RLS-0071 at a higher dose every 8 hours for a total of 3 doses (Arm B) or placebo dosed every 8 hours for a total of 3 doses (Arm C). Each subject completing the study will be evaluated for up to a total of 7 days. Subjects will be permitted to participate in only 1 arm of the study. Subjects discontinuing the study before data was collected at 6 hours post LPS challenge will be considered dropouts and will be replaced. | This is a Phase 1b, randomized, double-blind, placebo-controlled, dose range finding study to assess the safety, tolerability, pharmacodynamics (PK) and pharmacokinetics (PD) of RLS-0071 in healthy adult subjects after challenge with inhaled lipopolysaccharide (LPS). Clinical data are required to determine the potential benefit of RLS-0071, a novel drug that specifically inhibits multiple inflammatory pathways, for the treatment of severe asthma. This study has been designed to evaluate the efficacy of IV administered RLS-0071 to reduce inflammation symptoms in healthy subjects challenged with inhaled LPS, a well-known agent that produces a safe and well-controlled inflammatory response in the lung. This is a critical proof-of-concept study and dose-optimization study for future studies in severe asthma patients. A total of 48 healthy adult subjects are planned to be enrolled in this study. Subjects will be randomly allocated to either of the treatment arms (Arm A or Arm B) with RLS-0071 or the placebo arm (Arm C) in a 1:1:1 ratio. Subjects will either receive intravenous infusion of RLS-0071 at a lower dose every 8 hours for a total of 3 doses (Arm A), RLS-0071 at a higher dose every 8 hours for a total of 3 doses (Arm B) or placebo dosed every 8 hours for a total of 3 doses (Arm C). Each subject completing the study will be evaluated for up to a total of 7 days. Subjects will be permitted to participate in only 1 arm of the study. Subjects discontinuing the study before data was collected at 6 hours post LPS challenge will be considered dropouts and will be replaced. | 23.05.22 | 21.09.22 | |||
| 51.360 | A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease | A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease | COPD | COPD | BREATH | Recruiting | NCT06154837 | NCT06154837 | Interventional | DZL recruiting center | Externally - industry | The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD). | The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD). | 27.11.23 | 27.04.26 | |||
| 51.361 | A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated | A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated | COPD | COPD | BREATH | Closed | NCT04866160 | NCT04866160 | Interventional | DZL recruiting center | Externally - industry | The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD relationship. | The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD relationship. | 17.05.21 | 30.11.21 | |||
| 51.362 | Biosensor and Environmental Sensor Development Within the REMEDIA Project | Biosensor and Environmental Sensor Development Within the REMEDIA Project | COPD | COPD | BREATH | Closed | NCT06035276 | NCT06035276 | Interventional | DZL recruiting center | Externally - industry | The aim of this proof-of-concept study is to obtain data that will contribute to the development of sensor devices (biosensor and environmental sensor) for patients with lung diseases (e.g. COPD). The study aims to validate our previous results from healthy subjects by joint testing of the biosensor and environmental device in a real-world setting. Healthy subjects and COPD subjects will be exposed to air of a traffic dense urban region ("urban" air) and to filtered indoor air ("clean" air) during activity and rest. Environmental and biomarker sensors will be used to measure several biomarkers and environmental conditions. | The aim of this proof-of-concept study is to obtain data that will contribute to the development of sensor devices (biosensor and environmental sensor) for patients with lung diseases (e.g. COPD). The study aims to validate our previous results from healthy subjects by joint testing of the biosensor and environmental device in a real-world setting. Healthy subjects and COPD subjects will be exposed to air of a traffic dense urban region ("urban" air) and to filtered indoor air ("clean" air) during activity and rest. Environmental and biomarker sensors will be used to measure several biomarkers and environmental conditions. | 28.08.23 | 19.04.24 | |||
| 50.926 | A Phase 3, Open-label Study Evaluating the Longterm Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Open-label Study Evaluating the Longterm Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis | CFBE | Cystic Fibrosis | BREATH | Active / not recruiting | 2019-004881-16 | 2019-004881-16 | Interventional | DZL recruiting center | Externally - industry | Safety and tolerability of long-term treatment with VX-121/TEZ/D-IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry | Safety and tolerability of long-term treatment with VX-121/TEZ/D-IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry | 12.07.23 | 31.12.26 | |||
| 50.955 | A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. in patients with bronchiectasis (ClairleafTM) | A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. in patients with bronchiectasis (ClairleafTM) | CFBE | Bronchiectasis | CPC-M, BIH / Charité - Associated Partner, BREATH | Recruiting | NCT05846230 | 2023-503290-38-00 | NCT05846230, 2023-503290-38-00 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. in patients with bronchiectasis (ClairleafTM) | A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. in patients with bronchiectasis (ClairleafTM) | 27.03.24 | 30.03.26 | ||
| 50.957 | A randomised, double-blind, placebo-controlled, parallel group trial evaluating safety, tolerability, pharmacodynamics and pharmacokinetics of BI 1291583 one tablet once daily over 12 weeks versus placebo in adult patients with cystic fibrosis bronchiectasis (ClairaflyTM) (Böhringer_1397- 0013) | A randomised, double-blind, placebo-controlled, parallel group trial evaluating safety, tolerability, pharmacodynamics and pharmacokinetics of BI 1291583 one tablet once daily over 12 weeks versus placebo in adult patients with cystic fibrosis bronchiectasis (ClairaflyTM) (Böhringer_1397- 0013) | CFBE | CF Bronchiectasis | BIH / Charité - Associated Partner | Closed | NCT05865886 | 2022-502835-21-00 | NCT05865886, 2022-502835-21-00 | Interventional | DZL recruiting center, DZL on steering board | Externally - industry | The primary objective of the study is to investigate safety and tolerability of 5 mg BI 1291583 in patients with CFB following oral daily administration over 12 weeks. | The primary objective of the study is to investigate safety and tolerability of 5 mg BI 1291583 in patients with CFB following oral daily administration over 12 weeks. | 18.03.24 | 07.10.24 | ||
| 50.964 | A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma (EXHALE-3) | A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma (EXHALE-3) | AA | Asthma | BREATH | Recruiting | 2023-503693-20 | 2023-503693-20 | Interventional | DZL recruiting center | Externally - industry | The primary objective of the study is to demonstrate the efficacy of dexpramipexole in reducing severe asthma exacerbations. | The primary objective of the study is to demonstrate the efficacy of dexpramipexole in reducing severe asthma exacerbations. | 18.07.24 | 31.12.25 | |||
| 50.969 | A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis | A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis | CFBE | Bronchiectasis | CPC-M | Recruiting | 2023-508663-70 | 2023-508663-70 | Interventional | DZL recruiting center | Externally - industry | A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis | A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis | 26.09.24 | 31.12.25 | |||
| 50.998 | All age asthma cohort (ALLIANCE) - Adult Arm | All age asthma cohort (ALLIANCE) - Adult Arm | AA | Asthma and wheezing illness | ARCN, BREATH, CPC-M, UGMLC | Recruiting | NCT02419274 | NCT02419274 | Observational | DZL recruiting center, DZL Investigator Initiated Trial, DZL discovery-based | DZL, Externally - public | The all age asthma cohort (ALLIANCE) - from early beginnings to chronic disease: a longitudinal cohort study. The ALL Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL) is a prospective, multi-center, observational cohort study with seven recruiting sites across Germany. The aim is to decipher disease mechanisms in distinct subgroups with deep molecular (endo-) phenotyping of both children and adult patients with asthma in a prospective, longitudinal setting. | The all age asthma cohort (ALLIANCE) - from early beginnings to chronic disease: a longitudinal cohort study. The ALL Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL) is a prospective, multi-center, observational cohort study with seven recruiting sites across Germany. The aim is to decipher disease mechanisms in distinct subgroups with deep molecular (endo-) phenotyping of both children and adult patients with asthma in a prospective, longitudinal setting. | 01.01.12 | 31.01.40 | |||
| 50.999 | All age asthma cohort (ALLIANCE) - Pediatric Arm | All age asthma cohort (ALLIANCE) - Pediatric Arm | AA | Asthma and wheezing illness | ARCN, BREATH, CPC-M, UGMLC | Recruiting | NCT02496468 | NCT02496468 | Observational | DZL recruiting center, DZL Investigator Initiated Trial, DZL discovery-based | DZL, Externally - public | The ALL Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL) is a prospective, multi-center, observational cohort study with seven recruiting sites across Germany. The aim is to decipher disease mechanisms in distinct subgroups with deep molecular (endo-) phenotyping of both children and adult patients with asthma in a prospective, longitudinal setting. | The ALL Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL) is a prospective, multi-center, observational cohort study with seven recruiting sites across Germany. The aim is to decipher disease mechanisms in distinct subgroups with deep molecular (endo-) phenotyping of both children and adult patients with asthma in a prospective, longitudinal setting. | 01.01.12 | 31.01.40 | |||
| 51.016 | Asthma Control in Severe Asthma Patients Treated with Tezepelumab: a Prospective, Observational, Real-World Evidence Study (ASCENT) | Asthma Control in Severe Asthma Patients Treated with Tezepelumab: a Prospective, Observational, Real-World Evidence Study (ASCENT) | AA | Asthma | BREATH | Active / not recruiting | Observational | DZL recruiting center | Externally - industry | To describe participant-reported asthma symptom control using the Asthma Control Questionnaire (ACQ-6) at baselinea and up to 52 weeks following tezepelumab initiation | To describe participant-reported asthma symptom control using the Asthma Control Questionnaire (ACQ-6) at baselinea and up to 52 weeks following tezepelumab initiation | 06.10.23 | 03.02.25 | |||||
| 51.062 | Eine prospektive, Nicht-Interventionelle, multizentrische Beobachtungsstudie zur Bewertung der Wirksamkeit, des Anwendungsmusters und der subjektiv von Patienten angegebenen Ergebnisse von Dupilumab unter Alltagsbedingungen bei Patienten mit schwerem unzureichend kontrolliertem Asthma | Eine prospektive, Nicht-Interventionelle, multizentrische Beobachtungsstudie zur Bewertung der Wirksamkeit, des Anwendungsmusters und der subjektiv von Patienten angegebenen Ergebnisse von Dupilumab unter Alltagsbedingungen bei Patienten mit schwerem unzureichend kontrolliertem Asthma | AA | Asthma | BREATH | Active / not recruiting | Interventional | DZL recruiting center | Externally - industry | Charakterisierung der Patienten, die Dupilumab (DUPIXENT ®) unter Alltagsbedingungen zur Asthma-Behandlung erhalten, in Bezug auf ihre medizinische Vorgeschichte, sozio-demografischen und krankheitsbezogenen Merkmale, atopischen/allergischen Komorbiditäten, Begleittherapien und früheren und aktuellen Asthma-Behandlungen | Charakterisierung der Patienten, die Dupilumab (DUPIXENT ®) unter Alltagsbedingungen zur Asthma-Behandlung erhalten, in Bezug auf ihre medizinische Vorgeschichte, sozio-demografischen und krankheitsbezogenen Merkmale, atopischen/allergischen Komorbiditäten, Begleittherapien und früheren und aktuellen Asthma-Behandlungen | 28.04.21 | 30.09.27 | |||||
| 51.107 | LEOPARD | LEOPARD | DPLD | Bronchopulmonary dysplasia | CPC-M | Recruiting | Interventional | DZL Investigator Initiated Trial | Externally - public | The moment after birth is characterized by huge changes in lung physiology inclduing the need to transition from a liquid-filled to an air-filled lung to allow gas exchange via the lung. Very preterm infants have a high chest wall compliance but a low lung compliance making them prone to lung collapse and lung injury. All very preterm infants require some form of respiratory support, but the best level of positive end-expiratory pressure (PEEP) after birth remains unknown. The LEOPARD trial will assess whether in very preterm infants between 24 and 32 weeks gestational age, the provision of a higher PEEP of 10-12 cmH2O for the first ten minutes after birth is superior than a lower PEEP of 5-7 cmH2O during the first ten minutes after birth. We will collect physiological and clinical data from approximately 225 infants, the exact sample size calculation is currently ongoing, the study protocol will be published and the trial will be registered before inclusion of the first patient. | The moment after birth is characterized by huge changes in lung physiology inclduing the need to transition from a liquid-filled to an air-filled lung to allow gas exchange via the lung. Very preterm infants have a high chest wall compliance but a low lung compliance making them prone to lung collapse and lung injury. All very preterm infants require some form of respiratory support, but the best level of positive end-expiratory pressure (PEEP) after birth remains unknown. The LEOPARD trial will assess whether in very preterm infants between 24 and 32 weeks gestational age, the provision of a higher PEEP of 10-12 cmH2O for the first ten minutes after birth is superior than a lower PEEP of 5-7 cmH2O during the first ten minutes after birth. We will collect physiological and clinical data from approximately 225 infants, the exact sample size calculation is currently ongoing, the study protocol will be published and the trial will be registered before inclusion of the first patient. | 01.07.25 | 30.09.27 | |||||
| 51.109 | LOng term usability of the self-injecTion with the mepolizumab aUtoinjector or prefilled Syringe | LOng term usability of the self-injecTion with the mepolizumab aUtoinjector or prefilled Syringe | AA | Asthma | BREATH | Closed | Observational | DZL recruiting center | Externally - industry | Describe overall treatment satisfaction with Nucala autoinjector / prefilled syringe at the 6 and 12 months documentation with a verbal rating (Likert) scale and at baseline and at the 6 and 12 months documentation with the ITAQ (Injection Treatment Acceptance Questionnaire) | Describe overall treatment satisfaction with Nucala autoinjector / prefilled syringe at the 6 and 12 months documentation with a verbal rating (Likert) scale and at baseline and at the 6 and 12 months documentation with the ITAQ (Injection Treatment Acceptance Questionnaire) | 06.12.21 | 31.12.25 | |||||
| 51.146 | Post market surveillance of SIMEOX, medical device to support mucociliary clearance in patients with muco-obstructive lung disease in a domiciliary setting. | Post market surveillance of SIMEOX, medical device to support mucociliary clearance in patients with muco-obstructive lung disease in a domiciliary setting. | CFBE | Bronchiectasis | ARCN | Recruiting | Interventional | DZL recruiting center | Externally - industry | Post market surveillance of SIMEOX, medical device to support mucociliary clearance in patients with muco-obstructive lung disease in a domiciliary setting. | Post market surveillance of SIMEOX, medical device to support mucociliary clearance in patients with muco-obstructive lung disease in a domiciliary setting. | 11.11.24 | 31.12.25 | |||||
| 51.173 | Telemedizinisch gestützte Rehabilitation nach Covid-19 bei Kindern (LoCoKi Niedersachen) | Telemedizinisch gestützte Rehabilitation nach Covid-19 bei Kindern (LoCoKi Niedersachen) | DPLD | Children and adolescents after SARS-CoV-2 infection | BREATH | Closed | DRKS00028963 | DRKS00028963 | Interventional | DZL recruiting center | Externally - public | The primary aim of this study is to show that 3 months of individually guided training and education can improve the limited quality of life, resilience and cardiopulmonary function in children after Covid-19 infection. The concept of telemonitoring and coaching is intended to increase adherence to the agreed measures. | The primary aim of this study is to show that 3 months of individually guided training and education can improve the limited quality of life, resilience and cardiopulmonary function in children after Covid-19 infection. The concept of telemonitoring and coaching is intended to increase adherence to the agreed measures. | 01.03.22 | 30.04.25 | |||
| 51.176 | The Prospective German Non-CF-Bronchiectasis Registry (PROGNOSIS) | The Prospective German Non-CF-Bronchiectasis Registry (PROGNOSIS) | CFBE | Bronchiectasis, Non-CF bronchiectasis | ARCN, BREATH, CPC-M, TLRC, UGMLC | Recruiting | NCT02574143 | NCT02574143 | Observational | DZL on steering board, DZL Investigator Initiated Trial | DZL, Externally - public, Externally - industry | The Prospective German Non-CF-Bronchiectasis Registry. The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany. | The Prospective German Non-CF-Bronchiectasis Registry. The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany. | 01.10.15 | 31.12.26 | |||
| 51.183 | Triple A: Advancing Airway Microbiome Analyses within the DZL: Standardization, Education, and Cutting-Edge Trials on Microbiome Development in Early Childhood | Triple A: Advancing Airway Microbiome Analyses within the DZL: Standardization, Education, and Cutting-Edge Trials on Microbiome Development in Early Childhood | AA, CFBE, DPLD, PALI | asthma, cystic fibrosis and bronchopulmonary dysplasia | ARCN, BREATH, CPC-M, TLRC | Recruiting | Observational | DZL recruiting center, DZL Investigator Initiated Trial, DZL discovery-based, DZL on steering board | DZL | This project will train scientists across the German Center for Lung Research (DZL) on standardized workflows for microbial samples from the airways. The scientists involved will develop and test standardized workflows on airway samples obtained from pre-school children and infants from three diseases: asthma, cystic fibrosis and bronchopulmonary dysplasia, the lung disease of infants born pre-term. These research projects will identify components of the microbiome, the community of microbes from the airways, which act favorably or unfavorably on the development and progression of chronic lung diseases, which start in early childhood. The scientific questions asked in this project will improve our understanding of the interaction within the microbiome and its impact on respiratory health. | This project will train scientists across the German Center for Lung Research (DZL) on standardized workflows for microbial samples from the airways. The scientists involved will develop and test standardized workflows on airway samples obtained from pre-school children and infants from three diseases: asthma, cystic fibrosis and bronchopulmonary dysplasia, the lung disease of infants born pre-term. These research projects will identify components of the microbiome, the community of microbes from the airways, which act favorably or unfavorably on the development and progression of chronic lung diseases, which start in early childhood. The scientific questions asked in this project will improve our understanding of the interaction within the microbiome and its impact on respiratory health. | 01.05.24 | 31.12.27 | |||||
| 51.354 | A Clinical Study Investigating OM-85-IN Safety and Tolerability in Healthy Volunteers and Mild Allergic Asthma Patients | A Clinical Study Investigating OM-85-IN Safety and Tolerability in Healthy Volunteers and Mild Allergic Asthma Patients | AA | Asthma | BREATH | Closed | NCT06486662 | NCT06486662 | Interventional | DZL recruiting center | Externally - industry | This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients | This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients | 14.06.24 | 19.02.25 | |||
| 51.355 | A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers | A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers | AA | Asthma | BREATH | Closed | NCT04082754 | NCT04082754 | Interventional | DZL recruiting center | Externally - public | This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311. | This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311. | 28.11.29 | 14.11.23 | |||
| 51.356 | A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | AA | Asthma | BREATH | Recruiting | NCT06433921 | NCT06433921 | Interventional | DZL recruiting center | Externally - industry | The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. | The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. | 14.08.24 | 18.03.25 | |||
| 51.357 | Study to Evaluate the Pharmacokinetics and Pharmacodynamics of AZD4604 Given Via the Turbuhaler® Device in Adults With Mild Asthma. | Study to Evaluate the Pharmacokinetics and Pharmacodynamics of AZD4604 Given Via the Turbuhaler® Device in Adults With Mild Asthma. | AA | Asthma | BREATH | Not yet recruiting | NCT06732882 | NCT06732882 | Interventional | DZL recruiting center | Externally - industry | The study will investigate the Pharmacokinetic (PK), Pharmacodynamic (PD), the safety and tolerability of AZD4604, as well as to examine the effect of Fractional exhaled Nitric Oxide (FeNO) following the administration of the multiple doses of AZD4604 via Turbuhaler device. | The study will investigate the Pharmacokinetic (PK), Pharmacodynamic (PD), the safety and tolerability of AZD4604, as well as to examine the effect of Fractional exhaled Nitric Oxide (FeNO) following the administration of the multiple doses of AZD4604 via Turbuhaler device. | 27.02.25 | 17.09.25 | |||
| 51.358 | Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients (CODES) | Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients (CODES) | AA | Atopic Dermatitis | BREATH | Closed | NCT05019209 | NCT05019209 | Interventional | DZL recruiting center | DZL | The present study investigates the reaction of the skin upon exposure to house dust mite (HDM) in patients with atopic dermatitis who have antibodies against HDM in the blood. A further aim is to assess nasal symptoms after exposure to HDM in an allergen challenge chamber and compare the results with data from previous studies. | The present study investigates the reaction of the skin upon exposure to house dust mite (HDM) in patients with atopic dermatitis who have antibodies against HDM in the blood. A further aim is to assess nasal symptoms after exposure to HDM in an allergen challenge chamber and compare the results with data from previous studies. | 10.09.21 | 14.02.22 | |||
| 50.893 | A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab | A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab | AA | Asthma | BREATH | Active / not recruiting | 2020-003612-28 | 2020-003612-28 | Interventional | DZL recruiting center | Externally - industry | To evaluate the efficacy of GSK3511294 100 mg (SC) every 26 weeks versus maintaining existing treatment with either mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype who have previously benefited from anti-IL-5/5R therapy | To evaluate the efficacy of GSK3511294 100 mg (SC) every 26 weeks versus maintaining existing treatment with either mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype who have previously benefited from anti-IL-5/5R therapy | 02.05.24 | 01.09.25 | |||
| 50.898 | A Multicentre, Double-blind, Randomized, Parallel Group, Placebo Controlled, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (Destination) | A Multicentre, Double-blind, Randomized, Parallel Group, Placebo Controlled, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (Destination) | AA | Asthma | BREATH | Closed | 2018-002501-53 | 2018-002501-53 | Interventional | DZL recruiting center | Externally - industry | To evaluate the long-term safety and tolerability of tezepelumab in severe asthma subjects | To evaluate the long-term safety and tolerability of tezepelumab in severe asthma subjects | 06.01.20 | 01.09.22 | |||
| 50.906 | A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma | A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma | AA | Asthma | BREATH | Recruiting | 2022-502570-16-01 | 2022-502570-16-01 | Interventional | DZL recruiting center | Externally - industry | To evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function. | To evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function. | 05.09.24 | 31.12.25 | |||
| 50.961 | A randomized, double-blind, multiple-dose, placebo-controlled clinical study to investigate efficacy and safety of 4-week treatment with 24 mg daily of the human GATA-3-specific DNAzyme solution for inhalation (SB010) in patients with Type 2-driven asthma inadequately controlled with at least medium-dose inhaled corticosteroids and long-acting beta-agonists on biomarkers (GIANT-1) | A randomized, double-blind, multiple-dose, placebo-controlled clinical study to investigate efficacy and safety of 4-week treatment with 24 mg daily of the human GATA-3-specific DNAzyme solution for inhalation (SB010) in patients with Type 2-driven asthma inadequately controlled with at least medium-dose inhaled corticosteroids and long-acting beta-agonists on biomarkers (GIANT-1) | AA | Asthma | BREATH | Closed | 2020-005652-38 | 2020-005652-38 | Interventional | DZL recruiting center | Externally - industry | To evaluate the effect of once-daily oral inhalation of 1,2 ml SB010 containing 24mg human GATA-3-specific DNAzyme (hgd40), compared to placebo, on airway inflammation in patients with moderate to severe type 2 dominant asthma inadequately controlled on current medium-to-high dose inhaled corticosteroids (ICS) with long-acting β2-agonist (LABA) therapy (Global Initiative for Asthma [GINA 2020] treatment step 4 or 5). | To evaluate the effect of once-daily oral inhalation of 1,2 ml SB010 containing 24mg human GATA-3-specific DNAzyme (hgd40), compared to placebo, on airway inflammation in patients with moderate to severe type 2 dominant asthma inadequately controlled on current medium-to-high dose inhaled corticosteroids (ICS) with long-acting β2-agonist (LABA) therapy (Global Initiative for Asthma [GINA 2020] treatment step 4 or 5). | 13.09.21 | 03.04.23 | |||
| 50.965 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFECT OF DUPILUMAB ON EXERCISE CAPACITY IN PATIENTS WITH MODERATE-TO-SEVERE ASTHMA | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFECT OF DUPILUMAB ON EXERCISE CAPACITY IN PATIENTS WITH MODERATE-TO-SEVERE ASTHMA | AA | Asthma | BREATH | Closed | 2019-002742-20 | 2019-002742-20 | Interventional | DZL recruiting center | Externally - industry | The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. | The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. | 07.12.20 | 03.05.21 | |||
| 50.968 | A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4- Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4- Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF) | DPLD | Cough in Idiopathic Pulmonary Fibrosis | BREATH | Closed | 2023-505296-72-00 | NCT02419274 | Interventional | DZL recruiting center | Externally - industry | Effect of NAL ER on 24-hour cough frequency (coughs per hour) at Week 6 using objective digital cough monitoring. | Effect of NAL ER on 24-hour cough frequency (coughs per hour) at Week 6 using objective digital cough monitoring. | 17.05.24 | 28.02.25 | |||
| 50.990 | AA-BMF-Register: Zentrale Erfassung von Patientendaten und Biomaterialbank bei Aplastischen Anämien und Bone Marrow Failure Syndromen (AA-BMF) | AA-BMF-Register: Zentrale Erfassung von Patientendaten und Biomaterialbank bei Aplastischen Anämien und Bone Marrow Failure Syndromen (AA-BMF) | DPLD, PLB | Alle Patienten, bei denen der Verdacht auf eine aplastische Anämie, ein angeborenes aplastisches Syndrom, ein angeborenes Syndrom, welche mit Zytopenien assoziiert sind oder eine unklare Zytopenie besteht und Blut zur Telomerlängenbestimmung und ggf. genetischer Diagnostik an die Registerzentrale in Aachen übermittelt wird. | CPC-M | Recruiting | DRKS00034063 | DRKS00034063 | Observational | DZL recruiting center | Externally - public | Identify patients with ILD and short telomers. | Identify patients with ILD and short telomers. | 19.12.23 | 31.12.28 | |||
| 51.001 | ALOFT-IPF IM027-068: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis | ALOFT-IPF IM027-068: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis | DPLD | Participants with Idiopathic Pulmonary Fibrosis | CPC-M | Recruiting | 2023-503697-21-00 | 2023-503697-21-00 | Interventional | DZL recruiting center | Externally - industry | To evaluate the efficacy of 2 doses of BMS-986278, 60 and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at Week 52 | To evaluate the efficacy of 2 doses of BMS-986278, 60 and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at Week 52 | 01.10.24 | 31.12.25 | |||
| 51.019 | BAY 20425 | BAY 20425 | PALI | ARDS | BIH / Charité - Associated Partner | Closed | 2019-004950-26 | 2019-004950-26 | Interventional | DZL recruiting center | Externally - industry | This trial evaluates the safety and tolerability of adaptive escalating multiple doses (three times daily) of a soluble Guanylate Cyclase (sGC) Activator Inhale, as inhalation in intubated and mechanically ventilated adult patients with moderate and severe Acute Respiratory Distress Syndrome (ARDS). It is a pilot (phase Ib), first in patient, open label study which aims to test escalating multiple doses of BAY 1211163 for safety, tolerability, pharmacokinetics (PK) and PD. The first dose group will start with 400 μg. Based on the occurrence of predefined dose limiting events (DLE) the next dose group can be either escalated, de-escalated or maintained. Planned dose groups are 200 μg, 400 μg, 800 μg, 1600n μg and 3200 μg inhaled TID for 7 days. Patients will be followed up until Day 28. | This trial evaluates the safety and tolerability of adaptive escalating multiple doses (three times daily) of a soluble Guanylate Cyclase (sGC) Activator Inhale, as inhalation in intubated and mechanically ventilated adult patients with moderate and severe Acute Respiratory Distress Syndrome (ARDS). It is a pilot (phase Ib), first in patient, open label study which aims to test escalating multiple doses of BAY 1211163 for safety, tolerability, pharmacokinetics (PK) and PD. The first dose group will start with 400 μg. Based on the occurrence of predefined dose limiting events (DLE) the next dose group can be either escalated, de-escalated or maintained. Planned dose groups are 200 μg, 400 μg, 800 μg, 1600n μg and 3200 μg inhaled TID for 7 days. Patients will be followed up until Day 28. | 10.07.21 | 24.07.23 | |||
| 51.056 | ECCO²R - Minimally-invasive extracorporeal CO2 removal using a renal replacement therapy platform in hypercapnic patients with acute respiratory distress syndrome: results of a single-center observational study | ECCO²R - Minimally-invasive extracorporeal CO2 removal using a renal replacement therapy platform in hypercapnic patients with acute respiratory distress syndrome: results of a single-center observational study | PALI | ARDS | UGMLC | Closed | NCT04351906 | NCT04351906 | Observational | DZL on steering board | Externally - public | The primary goal of the study was to assess the efficacy and safety of minimally-invasive ECCO2R using RRT platforms in combination with RRT or as a “standalone” procedure as well as enhancing or maintaining lung-protective ventilation. Clinical, laboratory, and ventilation parameters were assessed at different time points up to 48 h after initiation of minimally-invasive ECCO2R. Clinical scores, such as SOFA, APACHE 2 (Acute Physiology And Chronic Health Evaluation 2) II and SAPS (Simplified Acute Physiology Score) II were additionally analyzed. | The primary goal of the study was to assess the efficacy and safety of minimally-invasive ECCO2R using RRT platforms in combination with RRT or as a “standalone” procedure as well as enhancing or maintaining lung-protective ventilation. Clinical, laboratory, and ventilation parameters were assessed at different time points up to 48 h after initiation of minimally-invasive ECCO2R. Clinical scores, such as SOFA, APACHE 2 (Acute Physiology And Chronic Health Evaluation 2) II and SAPS (Simplified Acute Physiology Score) II were additionally analyzed. | 03.05.20 | 31.12.24 | |||
| 51.059 | Effects of Invasive Mechanical Ventilation on the Right Ventricular Function | Effects of Invasive Mechanical Ventilation on the Right Ventricular Function | PH | Acute Respiratory Distress Syndrome (ARDS), Right Ventricular Failure | UGMLC | Recruiting | NCT05710419 | NCT05710419 | Observational | DZL Investigator Initiated Trial, DZL recruiting center | Externally - public | The goal of this observational study is to learn about the influence of mechanical ventilation on the right ventricular (RV) function. The primary focus is on methods which are routinely used to improve gas exchange in ventilated patients (positive end expiratory pressure [PEEP], inhalation of NO, prone positioning). The main questions it aims to answer are:1) Effects of prone positioning, PEEP and inhalation of NO on RV-function Are there determinants (clinical, laboratory, demographic, echocardiographic) for the right ventricular response to the above? | The goal of this observational study is to learn about the influence of mechanical ventilation on the right ventricular (RV) function. The primary focus is on methods which are routinely used to improve gas exchange in ventilated patients (positive end expiratory pressure [PEEP], inhalation of NO, prone positioning). The main questions it aims to answer are:1) Effects of prone positioning, PEEP and inhalation of NO on RV-function Are there determinants (clinical, laboratory, demographic, echocardiographic) for the right ventricular response to the above? | 01.11.22 | 30.11.25 | |||
| 51.063 | Eine randomisierte, doppelblinde, placebokontrollierte Parallelgruppenstudie zur Beurteilung der Wirksamkeit und Sicherheit von Dupilumab bei Patienten mit allergischer bronchopulmonaler Aspergillose | Eine randomisierte, doppelblinde, placebokontrollierte Parallelgruppenstudie zur Beurteilung der Wirksamkeit und Sicherheit von Dupilumab bei Patienten mit allergischer bronchopulmonaler Aspergillose | AA | Aspergillose | BREATH | Closed | 2019-002619-24 | 2019-002619-24 | Interventional | DZL recruiting center | Externally - industry | Das primäre Ziel der Studie besteht in der Beurteilung der Wirksamkeit von Dupilumab hinsichtlich der auf Jahresbasis umgerechneten Rate an Exazerbationen bei Patienten mit allergischer bronchopulmonaler Aspergillose (ABPA). | Das primäre Ziel der Studie besteht in der Beurteilung der Wirksamkeit von Dupilumab hinsichtlich der auf Jahresbasis umgerechneten Rate an Exazerbationen bei Patienten mit allergischer bronchopulmonaler Aspergillose (ABPA). | 04.01.21 | 01.07.22 | |||
| 51.080 | GEMINI Study - Assessment of Clinical Practice of Mechanical Ventilation After COVID-19 Pandemic Among 57 Countries: A Systematic Analysis for the Global BurdEn of Me-chanIcal VeNtilatIon | GEMINI Study - Assessment of Clinical Practice of Mechanical Ventilation After COVID-19 Pandemic Among 57 Countries: A Systematic Analysis for the Global BurdEn of Me-chanIcal VeNtilatIon | PALI | Acute Respiratory Failure | BREATH, UGMLC | Closed | NCT05392010 | NCT05392010 | Observational | DZL on steering board | Externally - industry | The main objective will be to evaluate the worldwide clinical practice of mechanical Ventilation in critically ill patients, as well as the medium-term clinical outcomes for the description of phenotypes of critically ill patients treated with mechanical ventilation. | The main objective will be to evaluate the worldwide clinical practice of mechanical Ventilation in critically ill patients, as well as the medium-term clinical outcomes for the description of phenotypes of critically ill patients treated with mechanical ventilation. | 01.10.22 | 30.09.24 | |||
| 51.087 | Influence of an endotracheal tube with subglottic suction and continuous cuff pressure measurement on the respiratory microbiome in mechanically ventilated patients (TUBOMIC-Trial) | Influence of an endotracheal tube with subglottic suction and continuous cuff pressure measurement on the respiratory microbiome in mechanically ventilated patients (TUBOMIC-Trial) | PALI | ARDS | TLRC | Closed | DRKS00029176 | DRKS00029176 | Interventional | DZL recruiting center, DZL Investigator Initiated Trial | DZL | In this exploratory, prospective, randomized clinical study, pathogen diagnostics using next-generation sequencing will be conducted on secretions, stool, and plasma samples from 50 visceral surgery intensive care patients with acute respiratory failure requiring airway management in the intensive care unit. Additionally, various inflammatory biomarkers will be measured in the plasma samples. | In this exploratory, prospective, randomized clinical study, pathogen diagnostics using next-generation sequencing will be conducted on secretions, stool, and plasma samples from 50 visceral surgery intensive care patients with acute respiratory failure requiring airway management in the intensive care unit. Additionally, various inflammatory biomarkers will be measured in the plasma samples. | 01.12.22 | 31.12.24 | |||
| 51.138 | PANTHER - Precision medicine Adaptive Network platform Trial in Hypoxaemic acutE respiratory failuRe | PANTHER - Precision medicine Adaptive Network platform Trial in Hypoxaemic acutE respiratory failuRe | PALI | ARDS | BIH / Charité - Associated Partner, UGMLC | Recruiting | Interventional | DZL on steering board | Externally - public | PANTHER is a Bayesian adaptive platform randomized clinical trial studying novel interventions to improve outcomes for patients with acute hypoxaemic respiratory failure. The aim is to find better ways to identify which subgroups of ARDS patients will respond to different treatments. The platform trial should test different treatments for ARDS in the hypoinflammatory and hyperinflammatory groups. | PANTHER is a Bayesian adaptive platform randomized clinical trial studying novel interventions to improve outcomes for patients with acute hypoxaemic respiratory failure. The aim is to find better ways to identify which subgroups of ARDS patients will respond to different treatments. The platform trial should test different treatments for ARDS in the hypoinflammatory and hyperinflammatory groups. | 01.06.24 | 31.05.29 | |||||
| 51.162 | ROCKaspire: A randomized, double-blind, placebo-controlled, parallel group, Phase 3 study, followed by open-label extensions, to evaluate the efficacy of oral belumosudil in adult participants with chronic lung allograft dysfunction (CLAD) following bilateral lung transplantation | ROCKaspire: A randomized, double-blind, placebo-controlled, parallel group, Phase 3 study, followed by open-label extensions, to evaluate the efficacy of oral belumosudil in adult participants with chronic lung allograft dysfunction (CLAD) following bilateral lung transplantation | ROR, DPLD | adult participants with chronic lung allograft dysfunction (CLAD) | CPC-M | Recruiting | 2023-503462-23-00 | 2023-503462-23-00 | Interventional | DZL recruiting center | Externally - industry | This study will evaluate the efficacy and safety of belumosudil treatment in male or female participants ≥18 years of age with CLAD Stages 1 or 2, at least 1 year post bilateral lung transplantation. | This study will evaluate the efficacy and safety of belumosudil treatment in male or female participants ≥18 years of age with CLAD Stages 1 or 2, at least 1 year post bilateral lung transplantation. | 01.12.24 | 01.06.26 | |||
| 51.166 | SEAL 19999 | SEAL 19999 | PALI | ARDS COVID-19 | BIH / Charité - Associated Partner | Closed | 2019-001078-27 | 2019-001078-27 | Interventional | DZL recruiting center | Externally - industry | PEGylated adrenomedullin is planned to be administered in mechanically ventilated ARDS patients by inhalation via endotracheal tube. | PEGylated adrenomedullin is planned to be administered in mechanically ventilated ARDS patients by inhalation via endotracheal tube. | 01.07.21 | 16.05.23 | |||
| 51.172 | TEFIBEOS: Tezepelumab (Anti-TSLP-mab) in progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia (TEFIBEOS) A prospective two-armed, phase II clinical multicentre randomized, placebocontrolled (2:1), blinded with open-label extension trial (TEFIBEOS) | TEFIBEOS: Tezepelumab (Anti-TSLP-mab) in progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia (TEFIBEOS) A prospective two-armed, phase II clinical multicentre randomized, placebocontrolled (2:1), blinded with open-label extension trial (TEFIBEOS) | DPLD | Adult patients with fibrotic interstitial lung disease and eosinophilia in blood or BAL | BREATH, CPC-M | Recruiting | 2022-003584-18 | 2022-003584-18 | Observational | DZL recruiting center, DZL Investigator Initiated Trial | DZL, Externally - industry | To investigate clinical and immunological effects and safety of Tezepelumab in progressive fibrotic ILDs with evidence of eosinophilia. In particular to research the efficacy of Tezepelumab to decrease peripheral blood eosinophilia when compared to placebo after 24 weeks | To investigate clinical and immunological effects and safety of Tezepelumab in progressive fibrotic ILDs with evidence of eosinophilia. In particular to research the efficacy of Tezepelumab to decrease peripheral blood eosinophilia when compared to placebo after 24 weeks | 11.01.24 | 31.12.26 | |||
| 51.352 | Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions (SIMBA) | Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions (SIMBA) | AA | Allergic Rhinitis | BREATH | Closed | NCT05245175 | NCT05245175 | Interventional | DZL recruiting center | DZL | Single-blind, within-block randomized, clean-air-controlled study to assess the effect of lactose and sodium chloride particles in patients with allergic rhinitis on nasal symptoms when challenged in the Fraunhofer Allergen Challenge Chamber | Single-blind, within-block randomized, clean-air-controlled study to assess the effect of lactose and sodium chloride particles in patients with allergic rhinitis on nasal symptoms when challenged in the Fraunhofer Allergen Challenge Chamber | 22.02.22 | 13.04.22 | |||
| 51.353 | Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis (UBAMBI) | Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis (UBAMBI) | AA | Allergic Rhinitis | BREATH | Closed | NCT05346718 | NCT05346718 | Interventional | DZL recruiting center | Externally - public | The ragweed Ambrosia artemisiifolia is spreading in northern Europe due to climate change. The pollen are considered highly allergenic and might trigger allergy symptoms at much lower concentrations than e.g. grass or birch pollen. This study aims to determine threshold concentrations for ragweed and birch pollen in patients with seasonal allergic rhinitis. Participants will be exposed in an allergen challenge chamber that was technically modified to maintain very low and stable pollen concentrations for several hours. The study design is adaptive, where the pollen concentrations are escalated or de-escalated based on interim analysis of resulting allergic symptoms. | The ragweed Ambrosia artemisiifolia is spreading in northern Europe due to climate change. The pollen are considered highly allergenic and might trigger allergy symptoms at much lower concentrations than e.g. grass or birch pollen. This study aims to determine threshold concentrations for ragweed and birch pollen in patients with seasonal allergic rhinitis. Participants will be exposed in an allergen challenge chamber that was technically modified to maintain very low and stable pollen concentrations for several hours. The study design is adaptive, where the pollen concentrations are escalated or de-escalated based on interim analysis of resulting allergic symptoms. | 01.09.22 | 06.12.24 | |||
| 51.046 | COVID-19 Antibody Responses in Cystic Fibrosis (CAR-CF) | COVID-19 Antibody Responses in Cystic Fibrosis (CAR-CF) | CFBE | Cystic Fibrosis | UGMLC | Active / not recruiting | Observational | DZL recruiting center | Externally - public | This study will collect blood samples from thousands of people with CF to see whether the person had a previous SARS-CoV-2 infection. The study will also explore the level of antibodies to SARS-CoV-2 after vaccination or after infection, and how they change over time. | This study will collect blood samples from thousands of people with CF to see whether the person had a previous SARS-CoV-2 infection. The study will also explore the level of antibodies to SARS-CoV-2 after vaccination or after infection, and how they change over time. | 23.11.21 | 24.02.25 |
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