What side effects are associated with this type of intervention?

P2X3 receptor antagonists, such as BLU-5937, commonly cause taste disturbances (dysgeusia). Other potential side effects include gastrointestinal issues like nausea and general symptoms such as fatigue. Broader treatments for chronic cough, like extended-release guaifenesin, may also lead to gastrointestinal disturbances, nervous system effects, and respiratory issues.

What prior FDA approvals exist?

Currently, there are no FDA-approved P2X3 receptor antagonists specifically for the treatment of chronic cough. BLU-5937 is being studied as a potential treatment for refractory chronic cough, which indicates a novel approach in this therapeutic area. Traditional treatments for chronic cough often include addressing underlying conditions such as asthma, GERD, or postnasal drip, and may involve the use of antitussives, antihistamines, or inhaled corticosteroids.

What other types of research exist?

Promising novel alternatives to BLU-5937 for Chronic Cough patients include gefapixant, another P2X3 receptor antagonist, which has shown efficacy in reducing cough frequency in clinical trials. Additionally, other potential treatments being explored include speech therapy and neuromodulators, which target different pathways involved in chronic cough.

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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

Pivotal Trial

Summary

This trial is testing BLU-5937, a medication aimed at reducing cough frequency in adults with persistent coughs that don't improve with other treatments. It works by affecting pathways that trigger the cough reflex.

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Coughing

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 4Eligibility criteria met

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.