Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine
NCT05846230 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term. Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the AirleafTM or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose. Participants visit the study site 10 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.
Conditions Studied
Interventions
- DRUG BI 1291583
- DRUG Placebo matching BI 1291583
Study Locations (20)
Texas
- Metroplex Pulmonary & Sleep Center — McKinney
- IMA Clinical Research San Antonio — San Antonio
- University of Texas Health Science Center at Tyler — Tyler
Other
- Universitair Ziekenhuis Gent — Ghent
- UZ Leuven — Leuven
- Medical Center "Zdrave-1" — Kozloduy
California
- Newport Native MD, Inc — Newport Beach
- University of California Davis — Sacramento
Florida
- Malcom Randall VA Medical Center — Gainesville
- University of Florida Health Jacksonville — Jacksonville
New South Wales
- Macquarie University — Macquarie Park
- Westmead Hospital — Westmead
Queensland
- Lung Research Queensland — Chermside
- Mater Research Institute — South Brisbane
Western Australia
- Institute for Respiratory Health — Nedlands
- Trialswest — Spearwood
Kansas
- University of Kansas Medical Center — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2023-09-08 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05846230
The ClinicalTrials.gov registry entry for NCT05846230 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Bronchiectasis appearing as the primary indexed condition, and to 2 interventions — of which BI 1291583 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05846230 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Texas, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05846230 about?
NCT05846230 is a clinical study titled "Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine". This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps p...
What is the current status of trial NCT05846230?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 268 participants. The study started on 2023-09-08. Estimated completion is 2027-03-31.
What conditions does trial NCT05846230 study?
This clinical trial studies the following conditions: Bronchiectasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05846230?
The interventions under investigation include: BI 1291583 (DRUG), Placebo matching BI 1291583 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05846230?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05846230 being conducted?
This trial has 20 study locations across California, Florida, Kansas, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.