Status:
ACTIVE_NOT_RECRUITING
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Lead Sponsor:
Bellus Health Inc. - a GSK company
Conditions:
Cough
Refractory Chronic Cough
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Detailed Description
The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 24 weeks.
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
Key Trial Info
Start Date :
December 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2027
Estimated Enrollment :
975 Patients enrolled
Trial Details
Trial ID
NCT05600777
Start Date
December 5 2022
End Date
March 17 2027
Last Update
April 15 2026
Active Locations (252)
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1
GSK Investigational Site
Foley, Alabama, United States, 36535
2
GSK Investigational Site
Litchfield Park, Arizona, United States, 85340
3
GSK Investigational Site
Phoenix, Arizona, United States, 85032
4
GSK Investigational Site
Los Angeles, California, United States, 90025