A study to test how well BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis (ClairaflyTM)
- Conditions
- cystic fibrosis bronchiectasisMedDRA version: 21.0Level: PTClassification code: 10006445Term: Bronchiectasis Class: 100000004855MedDRA version: 20.0Level: PTClassification code: 10011762Term: Cystic fibrosis Class: 100000004850Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2022-502835-21-00
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Age of patients when signing the informed consent =18 years., Historical clinical diagnosis of CF (symptoms of CF and sweat chloride = 60 mmol/L and/or 2 CF-causing CFTR mutations)., Investigator-confirmed diagnosis of BE by CT scan and clinical history consistent with BE (e.g., cough, chronic sputum production, recurrent respiratory infections). Subjects whose past chest CT records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years., History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: a. at least 2 exacerbations, or b. at least 1 exacerbation and an SGRQ Symptoms score of >40 at screening visit 1 For patients on stable oral or inhaled antibiotics as chronic treatment for BE, at least one exacerbation must have occurred while on stable antibiotics., Patients must be able to provide spontaneous or induced sputum samples., Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial., Male or female patients: Women of childbearing potential (WOCBP) 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 1% 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 patient information. Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.
Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or AST and/or ALT > 3.0x ULN at Visit 1., Estimated glomerular filtration rate (eGFR) according to CKD-EPI formula < 30 mL/min at Visit 1., Absolute blood neutrophil count < 1,000/mm3 (equivalent to < 1000 cells/µL or < 109 cells/L) at Visit 1., Any findings in the medical examination (including BP, PR, or ECG) and/or laboratory value assessed at Visit 1 or during screening period that in the opinion of the investigator may put the patient 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 patient remains in the trial. The justification for decision needs to be documented]., Positive serological tests for hepatitis B, hepatitis C (also confirmed with HCV RNA), or human immunodeficiency virus (HIV) infection, or known infection status., Further criteria apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method