Trials / Completed
CompletedNCT05238675
A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
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 (AirleafTM)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 322 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day. Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff. The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 1291583 | BI 1291583 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2022-04-28
- Primary completion
- 2024-05-01
- Completion
- 2024-05-30
- First posted
- 2022-02-14
- Last updated
- 2025-08-14
Locations
112 sites across 23 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05238675. Inclusion in this directory is not an endorsement.