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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Page 1 of 63 (252 locations)

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

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough | DecenTrialz