This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
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
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
Parallel
BLU-5937
DrugOral administration of BLU-5937 Tablets.
Placebo
DrugOral administration of matching placebo for BLU-5937 Tablets.
24-Hour Cough Frequency
Assessed using an ambulatory cough monitor
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24
An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.
Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
Change from Baseline in Cough Severity Visual Analogue Scale at Week 24
Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity.
Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analog Scale at Week 24
Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity.
Awake Cough Frequency at Week 24
Assessed using an ambulatory cough monitor
Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 24
Assessed using an ambulatory cough monitor
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