A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)
- Conditions
- refractory chronic cough
- Registration Number
- JPRN-jRCT2031230611
- Lead Sponsor
- Kawamoto Mika
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 825
Capable of giving signed informed consent
-Refractory chronic cough (including unexplained chronic cough) for at least one year
-Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose
-Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
-Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
-Respiratory tract infection within 4 weeks before screening
-Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
-History of malignancy in the last 5 years
-History of alcohol or drug abuse within the last 3 years
-Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
-Previous participation in a BLU-5937 trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method