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)
A Randomised, Double-blind, Parallel Group, Roll-over Study Evaluating Long-term Safety and Efficacy of Oral Doses of BI 1291583 q.d. in Patients With Bronchiectasis (Clairleafᵀᴹ)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Newport Native MD, Inc — Newport Beach, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (102 Sites)
Showing the first 25 of 102 sites.
- Newport Native MD, Inc — Newport Beach, California
- University of California Davis — Sacramento, California
- Malcom Randall VA Medical Center — Gainesville, Florida
- University of Florida Health Jacksonville — Jacksonville, Florida
- University of Kansas Medical Center — Kansas City, Kansas
- New York University Langone Medical Center — New York, New York
- University of Cincinnati — Cincinnati, Ohio
- Medical University of South Carolina — Charleston, South Carolina
- Metroplex Pulmonary & Sleep Center — McKinney, Texas
- IMA Clinical Research San Antonio — San Antonio, Texas
- University of Texas Health Science Center at Tyler — Tyler, Texas
- Macquarie University — Macquarie Park, New South Wales
- Westmead Hospital — Westmead, New South Wales
- Lung Research Queensland — Chermside, Queensland
- Mater Research Institute — South Brisbane, Queensland
- Institute for Respiratory Health — Nedlands, Western Australia
- Trialswest — Spearwood, Western Australia
- Universitair Ziekenhuis Gent — Ghent,
- UZ Leuven — Leuven,
- Medical Center Zdrave-1 OOD — Kozloduy,
- Medical Center Hera - Montana Branch — Montana,
- Medical Center ReSpiro Ltd — Razgrad,
- SHATPPD "Dr. Dimitar Gramatikov" — Rousse,
- Medical Center Hera EOOD — Sofia,
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bronchiectasis
- Simeox 200 US Study — Charleston, South Carolina
- OLE Therapy With BE Patients in Home Care Study — New Haven, Connecticut
- The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis — Birmingham, Alabama
- Itraconazole Therapy In Bronchiectasis With Airway Mold — Rochester, Minnesota
- Hypertonic Saline in NCFB — Chapel Hill, North Carolina
Explore by condition: All Bronchiectasis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.