Clinical Research Details

A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf™)

Study Description

A study to test whether different doses of BI 1291583 help people with bronchiectasis. If you join this study, you may receive the study drug being tested, BI 1291583, and/or placebo. The study drug will be taken as tablets at home every day and will be taken for up to about 48 weeks. This study will involve study procedures such as, physical exams, electrocardiograms (ECGs), urine tests, blood tests including infectious disease testing, fasting (no food or drinks but water) in the morning before certain study visits, breathing tests, sputum samples, 24-hour sputum collection, a computed tomography (CT) scan, dental exams, dental panoramic X-ray, and completing questionnaires.

Inclusion/Exclusion Criteria

Inclusion criteria: 1. Clinical history consistent with bronchiectasis and investigator confirmed diagnosis by computed tomography (CT) scan 2. History of 2 pulmonary exacerbations requiring antibiotic treatment in the last 12 months, or 1 exacerbation if SGRQ Symptoms score is >40 Exclusion criteria: 1. Cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency, a1-antitrypsin deficiency treated with augmentation therapy, current allergic bronchopulmonary aspergillosis 2. Acute infections 3. Unstable dose regimen of maintenance bronchiectasis treatment