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Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

CompletedPhase 2

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Refractory Chronic Cough

Interventions: BLU-5937, Placebo

Countries: United States, Canada, Czechia, Germany, Hungary, Poland, United Kingdom

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding 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 (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

Locations (116)

Peoria, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Northridge, California, United States
San Diego, California, United States
San Jose, California, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Largo, Florida, United States
Leesburg, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Sweetwater, Florida, United States
Columbus, Georgia, United States
Lawrenceville, Georgia, United States
Rincon, Georgia, United States
Normal, Illinois, United States
Evansville, Indiana, United States
Fort Mitchell, Kentucky, United States
North Dartmouth, Massachusetts, United States
Edina, Minnesota, United States
Rochester, Minnesota, United States
Woodbury, Minnesota, United States
Chesterfield, Missouri, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
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