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A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
Sponsor: Boehringer Ingelheim
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.
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Evaluating Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BI 1291583 One Tablet Once Daily Over 12 Weeks Versus Placebo in Adult Patients With Cystic Fibrosis Bronchiectasis (Clairafly™)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2024-04-05
Completion Date
2024-10-07
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
BI 1291583
Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
Placebo to BI 1291583
Once daily oral administration of tablets of placebo matching BI 1291583 for 12 weeks.
Locations (24)
National Jewish Health
Denver, Colorado, United States
Central Florida Pulmonary Group
Altamonte Springs, Florida, United States
Chest Medicine Associates
South Portland, Maine, United States
Northwell Health Physician Partners
New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Brussels - UNIV UZ Brussel
Brussels, Belgium
HOP Arnaud de Villeneuve
Montpellier, France
Hôpital Cochin
Paris, France
Hôpital Charles Nicolle
Rouen, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Klinikum der Universität München AÖR
München, Germany
Azienda Ospedaliera Meyer
Florence, Italy
Istituto G. Gaslini
Genova, Italy
IRCCS Fondazione Ospedale Maggiore
Milan, Italy
AOU San Luigi Gonzaga
Orbassano (TO), Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Amsterdam UMC, location VUMC
Amsterdam, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain