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NCT05865886 · ClinicalTrials.gov registry record · Phase 2
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
A Phase 2 study of Cystic Fibrosis and Bronchiectasis, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 12
- Study locations
NCT05865886: Completed Phase 2 study of Cystic Fibrosis and Bronchiectasis, sponsored by Boehringer Ingelheim.
NCT05865886 is a Phase 2 study of Cystic Fibrosis and Bronchiectasis that has completed, run by Boehringer Ingelheim. The registered enrollment target is 22 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (88% lower). The trial reports 12 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05865886, a Phase 2 study of Cystic Fibrosis and Bronchiectasis, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
Occurrence of any treatment emergent adverse events is expressed as percentages of participants with treatment emergent adverse events. Percentages are rounded to one decimal place.
Conditions Studied
Interventions
- DRUG BI 1291583
- DRUG Placebo to BI 1291583
Study Locations (12)
Other
- UZ Leuven - Leuven
- Charite Universitätsmedizin Berlin KöR - Berlin
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Essen
- Medizinische Hochschule Hannover - Hanover
- Universitätsklinikum Jena - Jena
- Azienda Ospedaliera Meyer - Florence
- Azienda Ospedaliera Universitaria Integrata Verona - Verona
- Amsterdam UMC, location VUMC - Amsterdam
- Universitair Medisch Centrum Utrecht - Utrecht
- Hospital Universitari Vall D Hebron - Barcelona
Kansas
- University of Kansas Medical Center - Kansas City
New York
- Northwell Health Physician Partners - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-04-05 |
| Est. Completion | 2024-10-07 |
| Phase | Phase 2 |
What the finished NCT05865886 record still lists
NCT05865886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which BI 1291583 is the first listed.
NCT05865886 lists 12 locations in 3 states (Other, Kansas, New York).
Frequently Asked Questions
What is clinical trial NCT05865886 about?
NCT05865886 is a clinical study titled "A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)". 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...
What is the current status of trial NCT05865886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2024-04-05. Estimated completion is 2024-10-07.
What conditions does trial NCT05865886 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Bronchiectasis.
What interventions are being tested in trial NCT05865886?
The interventions under investigation include: BI 1291583 (DRUG), Placebo to BI 1291583 (DRUG).
Who is sponsoring clinical trial NCT05865886?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05865886 being conducted?
This trial has 12 study locations across Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05865886's enrollment target sits among peer trials
22 126th of 169 higher than 44 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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