BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease 2020 report recommends that patients with chronic obstructive pulmonary disease (COPD) suffering from persistent dyspnea, despite long-acting β(2)-agonist (LABA)/inhaled corticosteroid (ICS) maintenance therapy, are switched to either a long-acting muscarinic antagonist (LAMA)/LABA combination regimen or LAMA/LABA/ICS triple therapy. However, to date, no studies have investigated the direct switch from LABA/ICS to LAMA/LABA therapy-instead of switching to triple therapy-in a prospective, real-world, non-interventional setting. METHODS: EVELUT(®) (NCT03954132) is an ongoing, prospective, open-label, multicenter, non-interventional study comparing the once-daily fixed-dose combination of tiotropium and olodaterol (tio/olo) versus any triple therapy (LAMA/LABA/ICS) in patients with COPD who are symptomatic despite LABA/ICS maintenance therapy. Patients with acute or frequent COPD exacerbations are excluded from the study. Participants will receive LABA/ICS maintenance treatment until Visit 1, followed by switching of treatment to tio/olo or LAMA/LABA/ICS. The primary endpoints are changes in modified Medical Research Council (mMRC) and COPD Assessment Test (CAT(®)) scores after approximately 12 weeks of treatment. Secondary endpoints are change in the patients' general condition according to the Physician's Global Evaluation score, the proportion of responders with a change in mMRC score of ≥1 and in CAT(®) score of ≥2, and patient satisfaction with the inhaler and therapy. The study is expected to enroll approximately 900 patients. CONCLUSION: EVELUT results are expected to add to the current real-world evidence informing therapeutic decisions for COPD in everyday clinical practice. TRIAL REGISTRATION: The European Union electronic Register of Post-authorisation Studies (EU PAS Register): EUPAS29784; the Federal Institute for Drugs and Medical Devices (BfArM): NIS Study No 7305; Clinicaltrials.gov: NCT03954132.
- Buhl, R.
- Dreher, M.
- Korn, S.
- Taube, C.
- Stock, C.
- Zehendner, C. M.
- Kondla, A.
- Vogelmeier, C. F.
Keywords
- *copd
- *lama/laba/ics
- *Spiolto® Respimat®
- *tiotropium/olodaterol
- *triple therapy
- GlaxoSmithKline, Novartis, and Roche, and personal fees from AstraZeneca, Chiesi,
- Cipla, Sanofi and Teva, outside the submitted work. Michael Dreher received speaking
- fees from Actelion, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Chiesi,
- Hamilton, Heinen und Löwenstein, Intermune, Linde, Novartis, Pfizer, Philips
- Respironics, ResMed, Roche, and Weinmann, and honoraria for advising from Almirall,
- Boehringer Ingelheim, Hamilton, Linde, Novartis, Pfizer, Philips Respironics,
- ResMed, and Roche
- and grants from Linde, Philips Respironics, ResMed and the German
- Federal Ministry of Education and Research (BMBF). Stephanie Korn received personal
- fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis,
- Roche, Sanofi and Teva, outside the submitted work. Christian Taube reports no
- conflict of interest. Christian Stock, Christoph M. Zehendner and Anke Kondla are
- employees of Boehringer Ingelheim. Claus F Vogelmeier reports personal fees from
- Almirall, Cipla, Berlin Chemie/Menarini, CSL Behring and Teva
- grants and personal
- fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols,
- MedUpdate, Mundipharma, Novartis, Nuvaira, OmniaMed, and Takeda
- and grants from the
- German Federal Ministry of Education and Research (BMBF) Competence Network Asthma
- and COPD (ASCONET), Bayer Schering Pharma AG, MSD and Pfizer, outside the submitted
- work. The authors report no other conflicts of interest in this work.
