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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)

  • NCT05846230
  • PHASE2
  • INTERVENTIONAL

Last updated: 2024-08-06

Purpose of  Trial

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.


This study is for people with

Bronchiectasis


Interventions being studied

BI 1291583

Placebo matching BI 1291583

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ELIGIBILITY

Gender: ALL

Age: 18+

Healthy Volunteers: No

11 Locations
Newport Beach

Newport Native MD, Inc


California, 92663, United States
Sacramento

University of California Davis


California, 95817, United States
Gainesville

Malcom Randall VA Medical Center


Florida, 32608, United States
Jacksonville

University of Florida Health Jacksonville


Florida, 32209, United States
Kansas City

University of Kansas Medical Center


Kansas, 66160, United States
New York

New York University Langone Medical Center


New York, 10016, United States
Cincinnati

University of Cincinnati


Ohio, 45267, United States
Charleston

Medical University of South Carolina


South Carolina, 29425, United States
McKinney

Metroplex Pulmonary & Sleep Center


Texas, 75069, United States
San Antonio

IMA Clinical Research San Antonio


Texas, 78229, United States
Tyler

University of Texas Health Science Center at Tyler


Texas, 75708, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

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