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ACTIVE_NOT_RECRUITINGPHASE3

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)

NCT05599191•Bellus Health Inc. - a GSK company

View on ClinicalTrials.gov

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 12 weeks.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (191)

GSK Investigational Site

Litchfield Park, Arizona, United States

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Encinitas, California, United States

GSK Investigational Site

Mission Viejo, California, United States

GSK Investigational Site

Paramount, California, United States

GSK Investigational Site

Roseville, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Gainesville, Florida, United States

Key Dates

Start Date

October 25, 2022

Primary Completion Date

December 18, 2025

Completion Date

May 28, 2026

Last Updated

June 10, 2025

Enrollment

825

ESTIMATED participants

Conditions

CoughRefractory Chronic Cough

Interventions

BLU-5937

DRUG

Placebo

DRUG

Laryngeal Cryotherapy for Refractory Neurogenic Cough

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Inclusion Criteria

Exclusion Criteria

Laryngeal Cryotherapy for Refractory Neurogenic Cough

Validation of the C-mo System - Cough Monitoring

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial

Development of a Cough Control Questionnaire (CCQ)

Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents