What side effects are associated with this type of intervention?

Common treatments for chronic cough, including P2X3 receptor antagonists like BLU-5937, often have side effects such as taste disturbances (dysgeusia), which is the most frequently reported adverse effect. Other potential side effects may include gastrointestinal issues, such as nausea and diarrhea, and respiratory symptoms like throat irritation. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved P2X3 receptor antagonists specifically for the treatment of chronic cough. BLU-5937 is currently being studied in a Phase 3 trial for its efficacy and safety in treating refractory chronic cough. Other treatments for chronic cough typically include antitussives like dextromethorphan and codeine, which act on different mechanisms compared to P2X3 receptor antagonists.

What other types of research exist?

Promising novel alternatives to BLU-5937 for chronic cough patients include gefapixant (a P2X3 receptor antagonist currently in late-stage clinical trials) and eliapixant (another P2X3 receptor antagonist under investigation). These alternatives are being studied for their efficacy and safety in treating refractory chronic cough.

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BLU-5937 for Chronic Cough

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

Respiratory tract infection within 4 weeks before screening

History of malignancy in the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called BLU-5937 to see if it can help reduce coughing in adults who have a persistent cough that doesn't get better with usual treatments. The study will measure how often participants cough over a period of several months after taking the medication.

Who is the study for?

Adults with a persistent cough lasting over a year, not explained by other lung conditions like COPD or asthma, can join this study. They must be non-smokers for at least six months and have no recent infections or history of serious illness like cancer within the past five years.

What is being tested?

The trial is testing BLU-5937, a potential new medication for chronic cough that hasn't responded to other treatments. Participants will either receive BLU-5937 or a placebo (a substance with no active drug) over 24 weeks to compare effectiveness and safety.

What are the potential side effects?

Specific side effects of BLU-5937 are not listed here, but common side effects in trials may include nausea, headache, dizziness, and fatigue. Placebo groups typically experience fewer side effects since they do not contain an active drug.

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 a respiratory infection in the last 4 weeks.

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I have had cancer in the past 5 years.

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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 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 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 24

Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24

Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24

+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

Chronic Cough treatments often target the underlying mechanisms that trigger cough reflexes. One such treatment is the P2X3 receptor antagonist, like BLU-5937, which works by blocking the P2X3 receptors involved in the cough reflex pathway, thereby reducing the frequency and severity of coughing. This is particularly important for Chronic Cough patients as it directly addresses the hypersensitivity of sensory nerves in the airways, providing relief from persistent coughing. Other common treatments include inhaled corticosteroids and beta agonists, which reduce inflammation and relax airway muscles, respectively, helping to alleviate cough symptoms. Understanding these mechanisms allows for targeted therapy, improving patient outcomes and quality of life.

Dilemmas, Confusion, and Misconceptions Related to Small Airways Directed Therapy.