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

• Status: Not yet recruiting
• Trial end date: 2026-03-30

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. We also want to know how well people with this condition can tolerate BI 1291583 in the long term.

This study has 2 parts. The purpose of the first part is to find the best dose of BI 1291583 to use in the second part. In the first part, participants take a low, medium, or high dose of BI 1291583 as a tablet once a day. 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 BI 1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM study continue to take the same dose. This part of the study takes about 1 year. In the second part, all participants take the same dose of BI 1291583 for an extended period to find out how well this treatment is tolerated. The duration of the second part of the study may be different among participants. They can stay in the study if they benefit from treatment and can tolerate it.

• Phase: Phase 2

Details

• Lead Sponsor: Boehringer Ingelheim