Health Condition 1: J47- Bronchiectasis
Conditions
Interventions
Intervention1: BI 1291583
: Dose: 2.5 mg
Route: oral
Frequency: 1 tablet daily
Control Intervention1: Placebo to BI 1291583 film-coated tablets
: Dose: matching placebo
Route: oral
Frequency: 1 table
Sponsors
Boehringer Ingelheim International GmbH
IQVIA RDS India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants WOCBP1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1percent per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information. 2. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation. 3. Age of participants when signing the informed consent more than equals to 18 (at least the legal age of consent in countries where it is greater than 18 years) years. 4. Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan. Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years. 5. Participants should be able to produce sputum for screening (see the SOA). 6. History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either: a. at least 2 exacerbations, or b. at least 1 exacerbation and an SGRQ Symptoms score of more than 40 at screening Visit 1 For participants on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on CFTR-MT, at least one exacerbation must have occurred since initiation of stable antibiotics or CFTR-MT.
Exclusion criteria
Exclusion criteria: 1. Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment). 2. An absolute blood neutrophil count more than 1,000/mm3 (equivalent to more than 1,000 cells/micro L or more than 109 Cells per L) at Visit 1. 3. eGFR according to CKD-EPI formula more than 30 mL per min at Visit 1. 4. Total IgG levels more than 5g per l at Visit 1. 5. Any findings in the medical examination and or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial. (Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomisation. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the participant remains in the trial. The justification for decision needs to be documented). 6. Relevant chronic or acute infections including but not limited to HIV and viral hepatitis. The corresponding laboratory tests will be performed during screening. Criteria for assessment of exclusionary lab tests for HIV and viral hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate superiority of BI 1291583 2.5 mg compared to placebo on the primary endpoint, the annualized rate of adjudicated pulmonary exacerbations in participants with bronchiectasisTimepoint: Week 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate a reduction in lung function decline as measured by the change from baseline in FEV1 %pred and FVC %pred, an improvement in the respiratory symptoms as measured by the absolute change from baseline in QOL-B respiratory symptoms score, a risk reduction in pulmonary exacerbations and a reduction in the annualized rate of severe pulmonary exacerbations for BI 1291583 2.5 mg when compared to placeboTimepoint: Week 76 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Republic of Korea, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed