A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
About the study
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
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How to Apply
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Answer a few questions to get started.Study Details
Contition
Cough,Refractory Chronic Cough
Age
18+
Phase
PHASE3
Participants Needed
975
Est. Completion Date
Mar 23, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Bellus Health Inc. - a GSK company
ClinicalTrials.gov NCT Identifier
NCT05600777
Study Number
BUS-P3-02
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