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COMPLETED
NCT05865886
PHASE2

A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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

Interventions

DRUG

BI 1291583

Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks.

DRUG

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