Do you have bronchiectasis and experience flare-ups (also called exacerbations)?
This study is open to adults with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.
Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants complete a daily diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.
What you need to know
Who can take part?
- Participants aged ≥18
- Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by Computed Tomography (CT) scan.
- Participants should be able to produce sputum for screening.
- History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1.
What is involved for me?
- ECG Heart Assessment
- Lung Function Test
- Sputum Samples
- Blood and Urinary Tests
- Chest CT
- Electronic Diary to record your symptoms and medications intake
- Study related questionnaires
- Take study medication.