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BLU-5937 for Chronic Cough (CALM-1 Trial)

Phase 3
Recruiting
Research Sponsored by Bellus Health Inc. - a GSK company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Refractory chronic cough (including unexplained chronic cough) for at least one year
Be older than 18 years old
Must not have
History of malignancy in the last 5 years
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

This trial will study a new drug for chronic, uncontrollable coughing.

Who is the study for?
Adults with a persistent cough lasting over a year that hasn't improved with treatment can join. They must be able to consent and, if they can have children, use effective birth control during the study and for two weeks after. People who've abused substances recently, participated in BLU-5937 trials before, had certain infections or cancers, smoke currently or quit recently, or have specific lung diseases cannot participate.Check my eligibility
What is being tested?
The trial is testing BLU-5937's effectiveness and safety against a placebo over one year in adults with refractory chronic cough. Participants will randomly receive either the actual drug or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
While specific side effects of BLU-5937 are not listed here, common side effects from medications like this may include headache, nausea, dizziness or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a chronic cough for at least one year that hasn't improved with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had any other cancers in the last 5 years.
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I currently smoke or vape, quit within the last 6 months, or have a history of heavy smoking.
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I have been diagnosed with COPD, bronchiectasis, idiopathic pulmonary fibrosis, or uncontrolled asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Coughing
Secondary outcome measures
Change from Baseline in Cough Severity Visual Analogue Scale at Week 12
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BLU-5937 50 mgExperimental Treatment1 Intervention
BLU-5937 oral dose 50 mg twice a day.
Group II: BLU-5937 25 mgExperimental Treatment1 Intervention
BLU-5937 oral dose 25 mg twice a day.
Group III: PlaceboPlacebo Group1 Intervention
Matching Placebo for BLU-5937 oral dose twice a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BLU-5937
2021
Completed Phase 2
~580

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for chronic cough work by targeting different aspects of the cough reflex and mucus clearance. BLU-5937, a P2X3 receptor antagonist, blocks the P2X3 receptors that are hypersensitive in chronic cough conditions, thereby reducing the cough reflex. This is crucial for chronic cough patients as it directly addresses the underlying hypersensitivity causing persistent coughing. Other treatments include antitussives, which suppress the cough reflex, and expectorants, which aid in clearing mucus from the airways. These mechanisms are essential for effectively managing symptoms and improving the quality of life for chronic cough patients.
Dilemmas, Confusion, and Misconceptions Related to Small Airways Directed Therapy.

Find a Location

Who is running the clinical trial?

Bellus Health Inc. - a GSK companyLead Sponsor
17 Previous Clinical Trials
4,513 Total Patients Enrolled
3 Trials studying Chronic Cough
1,203 Patients Enrolled for Chronic Cough
Bellus Health IncLead Sponsor
15 Previous Clinical Trials
4,447 Total Patients Enrolled
3 Trials studying Chronic Cough
1,203 Patients Enrolled for Chronic Cough

Media Library

BLU-5937 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05599191 — Phase 3
Chronic Cough Research Study Groups: BLU-5937 25 mg, BLU-5937 50 mg, Placebo
Chronic Cough Clinical Trial 2023: BLU-5937 Highlights & Side Effects. Trial Name: NCT05599191 — Phase 3
BLU-5937 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05599191 — Phase 3
Chronic Cough Patient Testimony for trial: Trial Name: NCT05599191 — Phase 3
~315 spots leftby Sep 2025