Science and Research

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.

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

Study details
Study-ID: 2023-510249-79-00
DZL Disease Area: DPLD
Study Type: Interventional
DZL Role: DZL recruiting center
Funding: Externally - industry
DZL Participating Sites: BREATH
Start Date: 10.10.2024
Completion Date: 31.12.2025
Status: Recruiting


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