A Phase 3, 24-Week, Randomized, Efficacy and Safety Study with Openlabel Extension of BLU-5937 in Adult Participants with Refractory or Unexplained Chronic Cough (CALM-2)
- Conditions
- Refractory Chronic Cough, Including Unexplained Chronic CoughMedDRA version: 21.0Level: LLTClassification code: 10080782Term: Refractory chronic cough Class: 10038738MedDRA version: 21.1Level: LLTClassification code: 10066656Term: Chronic cough Class: 10038738Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2024-513462-19-00
- Lead Sponsor
- Bellus Health Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 771
1. Between 18 and 80 years of age inclusive 2. Capable of understanding the written informed consent 3. Diagnosis of Refractory chronic cough (including unexplained chronic cough) for = 1 year prior to Screening 4. Participants must meet the cough frequency criteria 5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to the contraceptive guidance
1. Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vapors or Individuals who have given up smoking or vaping within the past 6 months, or those with > 20 pack-year smoking history 2. Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, or uncontrolled asthma 3. History of upper and/or lower respiratory tract infection or significant change in pulmonary status within 28 days of Screening 4. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at Screening 5. Medical history of malignancy and treatment completed = 5 years prior to Screening 6. History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years 7. Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at Screening 8. Previous participation in an investigational study of BLU-5937
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