A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses of BLU-5937 in Adult Participants With Refractory Chronic Cough
Overview
- Phase
- Phase 2
- Intervention
- BLU-5937
- Conditions
- Refractory Chronic Cough
- Sponsor
- Bellus Health Inc. - a GSK company
- Enrollment
- 310
- Locations
- 115
- Primary Endpoint
- Change from baseline in the 24-hour cough frequency
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Detailed Description
The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.
Investigators
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
Arms & Interventions
BLU-5937 Dose A
BLU-5937 oral dose A twice a day.
Intervention: BLU-5937
BLU-5937 Dose B
BLU-5937 oral dose B twice a day.
Intervention: BLU-5937
BLU-5937 Dose C
BLU-5937 oral dose C twice a day.
Intervention: BLU-5937
Placebo
Matching Placebo for BLU-5937 oral dose twice a day.
Intervention: Placebo
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)
BLU-5937 oral dose A twice a day.
Intervention: BLU-5937
Placebo (Population with baseline cough < 25 coughs/hour)
Matching Placebo for BLU-5937 oral dose twice a day.
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in the 24-hour cough frequency
Time Frame: Week 4
Assessed using an ambulatory cough monitor
Secondary Outcomes
- Change from Baseline in Leicester Cough Questionnaire (LCQ)(Week 4)
- Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)(2 Weeks after the last study medication intake)
- Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%(Week 4)
- Change from baseline in cough severity(Week 4)
- Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)(2 Weeks after the last study medication intake)