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
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 1291583: Tablet
Placebo matching BI 1291583: Tablet
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.
Eligibility
Primary outcome measure(s)
- Occurrence of treatment-emergent adverse events (TEAEs) — up to 12 months
Trial sites (102)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Medical Center Zdrave-1 OOD | Kozloduy | Bulgaria | |
| Medical Center Hera - Montana Branch | Montana | Bulgaria | |
| Medical Center ReSpiro Ltd | Razgrad | Bulgaria | |
| SHATPPD "Dr. Dimitar Gramatikov" | Rousse | Bulgaria | |
| Medical Center Hera EOOD | Sofia | Bulgaria | |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) | Québec | Canada | |
| Pulmonary Private Practice Kralupy | Kralupy nad Vltavou | Czechia | |
| The First Pulmonary Private Practice | Prague | Czechia | |
| Aalborg Sygehus Syd | Aalborg | Denmark | |
| Hvidovre Hospital | Hvidovre | Denmark | |
| Copenhagen University Hospital, Rigshospitalet | København Ø | Denmark | |
| Odense University Hospital | Odense | Denmark | |
| Sjællands Universitetshospital | Roskilde | Denmark | |
| Vejle University Hospital | Vejle | Denmark | |
| CHU Amiens-Picardie | Amiens | France | |
| HOP Arnaud de Villeneuve | Montpellier | France | |
| HOP Pontchaillou | Rennes | France | |
| Charité - Universitätsmedizin Berlin | Berlin | Germany | |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | Germany | |
| IKF Pneumologie GmbH & Co. KG | Frankfurt | Germany |
+ 62 more sites — see the full list on the official registry below.
More Boehringer Ingelheim trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05846230 on ClinicalTrials.gov ↗ ← All trials in France