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A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Active Not RecruitingPhase 3

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Cough, Refractory Chronic Cough

Interventions: BLU-5937, Placebo

Countries: United States, Australia, Canada, China, Czechia, Germany, India, Japan

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment
* 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

Locations (242)

Foley, Alabama, United States
Litchfield Park, Arizona, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Paramount, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Jose, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Wheat Ridge, Colorado, United States
Washington D.C., District of Columbia, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Orlando, Florida, United States
Santa Rosa Beach, Florida, United States
Sarasota, Florida, United States
Sweetwater, Florida, United States
Cumming, Georgia, United States
Chicago, Illinois, United States
River Forest, Illinois, United States
West Des Moines, Iowa, United States
Lexington, Kentucky, United States
Chevy Chase, Maryland, United States
Methuen, Massachusetts, United States
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