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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Cough, Refractory Chronic Cough

In brief

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Key facts

Study ID

NCT05600777

Run by

Bellus Health Inc. - a GSK company

People needed

997

Starts

2022-12-05

Expected to finish

2027-03-17

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Osaka, Japan
• GSK Investigational Site — Osaka, Japan
• GSK Investigational Site — Osaka, Japan
• GSK Investigational Site — Saitama, Japan
• GSK Investigational Site — Shizuoka, Japan
• GSK Investigational Site — Shizuoka, Japan
• GSK Investigational Site — Shizuoka, Japan
• GSK Investigational Site — Shizuoka, Japan
• GSK Investigational Site — Tochigi, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — Tokyo, Japan
• GSK Investigational Site — Toyama, Japan
• GSK Investigational Site — Yokohama, Japan
• GSK Investigational Site — Havelock North, Hawke's Bay Region, New Zealand
• GSK Investigational Site — Ebdentown, Upper Hutt, New Zealand
• GSK Investigational Site — Marburg, Germany
• GSK Investigational Site — München, Germany
• GSK Investigational Site — Neu-Isenburg, Germany
• GSK Investigational Site — Peine, Germany
• GSK Investigational Site — Schleswig, Germany
• GSK Investigational Site — Wallerfing, Germany
• GSK Investigational Site — Osaka, Japan

Full record on ClinicalTrials.gov

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