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A 24-Week Study of the Effica...

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

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2027-03-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cough Refractory Chronic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BLU-5937 25 mg

BLU-5937 oral dose 25 mg twice a day.

Group Type EXPERIMENTAL

BLU-5937

Intervention Type DRUG

Oral administration of BLU-5937 Tablets

BLU-5937 50 mg

BLU-5937 oral dose 50 mg twice a day.

Group Type EXPERIMENTAL

BLU-5937

Intervention Type DRUG

Oral administration of BLU-5937 Tablets

Placebo

Matching Placebo for BLU-5937 oral dose twice a day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration of matching placebo for BLU-5937 Tablets

Interventions

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BLU-5937

Oral administration of BLU-5937 Tablets

Intervention Type DRUG

Placebo

Oral administration of matching placebo for BLU-5937 Tablets

Intervention Type DRUG

Other Intervention Names

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Camlipixant

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

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US GSK Clinical Trials Call Center

Role: CONTACT

[email protected]

877-379-3718

EU GSK Clinical Trials Call Center

Role: CONTACT

[email protected]

Role: backup

[email protected]

+44 (0) 20 8990 4466

Other Identifiers

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BUS-P3-02

Identifier Type: OTHER

Identifier Source: secondary_id

2024-513462-19-00

Identifier Type: OTHER

Identifier Source: secondary_id

221851

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough

Evaluation of S-600918 in Adults With Refractory Chronic Cough

Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation

Detailed Description

Conditions

Study Design

Study Groups

BLU-5937 25 mg

BLU-5937

BLU-5937 50 mg

BLU-5937

Placebo

Placebo

Interventions

BLU-5937

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Bellus Health Inc. - a GSK company

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

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