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A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

CompletedPhase 3

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Cough, Refractory Chronic Cough

Interventions: BLU-5937, Placebo

Countries: United States, Argentina, Belgium, Canada, Colombia, France, Hungary, India

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 (200)

Jasper, Alabama, United States
Litchfield Park, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Encinitas, California, United States
Mission Viejo, California, United States
Paramount, California, United States
Roseville, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Lawrenceville, Georgia, United States
Normal, Illinois, United States
Oak Lawn, Illinois, United States
Ames, Iowa, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Crowley, Louisiana, United States
Shreveport, Louisiana, United States
Annapolis, Maryland, United States
North Dartmouth, Massachusetts, United States
Ann Arbor, Michigan, United States
+ 170 more on CT.gov