Science and Research

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

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.

Study details
Study-ID: NCT04594369, 2020-003688-25
Study-ID: NCT04594369, 2020-003688-25
DZL Disease Area: CFBE
DZL Disease Area: CFBE
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL Investigator Initiated Trial, DZL recruiting center
DZL Role: DZL Investigator Initiated Trial, DZL recruiting center
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: BREATH, CPC-M, TLRC, UGMLC, BIH / Charité - Associated Partner
DZL Participating Sites: BREATH, CPC-M, TLRC, UGMLC, BIH / Charité - Associated Partner
Start Date: 08.04.2021
Completion Date: 27.08.2024
Status: Closed
Status: Closed
DZL Investigator Initiated Trial, DZL recruiting center
Link to Study


chevron-down