Trials / Completed
CompletedNCT05865886
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
A Randomized, 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 (Clairafly™)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 1291583 | Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks. |
| DRUG | Placebo to BI 1291583 | Once daily oral administration of tablets of placebo matching BI 1291583 for 12 weeks. |
Timeline
- Start date
- 2024-04-05
- Primary completion
- 2024-10-07
- Completion
- 2024-10-07
- First posted
- 2023-05-19
- Last updated
- 2025-11-18
- Results posted
- 2025-11-18
Locations
12 sites across 6 countries: United States, Belgium, Germany, Italy, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05865886. Inclusion in this directory is not an endorsement.