A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
Public ClinicalTrials.gov record NCT05238675. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05238675
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 322 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 28, 2022 (Actual)
- Primary completion
- May 1, 2024 (Actual)
- Completion
- May 30, 2024 (Actual)
- Last update posted
- Jul 28, 2026
2022 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Medical Group | Peoria | Arizona | 85381 | — |
| Newport Native MD, Inc | Newport Beach | California | 92663 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| Central Florida Pulmonary Group | Altamonte Springs | Florida | 32701 | — |
| Malcom Randall VA Medical Center | Gainesville | Florida | 32608 | — |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| NewYork-Presbyterian/Weill Cornell Medical Center | New York | New York | 10065 | — |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | — |
| Metroplex Pulmonary & Sleep Center | McKinney | Texas | 75069 | — |
| Diagnostics Research Group | San Antonio | Texas | 78229 | — |
| University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 96 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05238675, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05238675 live on ClinicalTrials.gov.