1397-0017: Clairleaf: A study to test long-term treatment with BI 1291583
Research type
Research Study
Full title
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)
IRAS ID
1008032
Contact name
Medical Information -
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research 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). 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 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 study continue to take the same dose. Participants visit the study site 9 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.
REC name
Wales REC 3
REC reference
23/WA/0296
Date of REC Opinion
8 Nov 2023
REC opinion
Further Information Favourable Opinion