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

NCT ID: NCT05599191

Last Updated: 2025-06-10

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2026-05-28

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).

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 12 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

No

Sponsors

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Bellus Health Inc. - a GSK company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Litchfield Park, Arizona, United States

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Scottsdale, Arizona, United States

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Encinitas, California, United States

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Mission Viejo, California, United States

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Paramount, California, United States

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Roseville, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Clearwater, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Lawrenceville, Georgia, United States

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Normal, Illinois, United States

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Oak Lawn, Illinois, United States

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Ames, Iowa, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Crowley, Louisiana, United States

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Shreveport, Louisiana, United States

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Annapolis, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Ypsilanti, Michigan, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Jersey City, New Jersey, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Charleston, South Carolina, United States

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Little River, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Rock Hill, South Carolina, United States

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Bristol, Tennessee, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Williamsburg, Virginia, United States

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Bellevue, Washington, United States

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Bellingham, Washington, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Ciudad Autonoma de Buenos Aire, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Santa Fe, , Argentina

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Vicente López, , Argentina

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Brussels, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Mechelen, , Belgium

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Roeselare, , Belgium

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Kelowna, British Columbia, Canada

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Ajax, Ontario, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Victoriaville, Quebec, Canada

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Burlington, , Canada

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Floridablanca, , Colombia

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Medellín, , Colombia

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Dijon, , France

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Lille, , France

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Toulouse, , France

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Balatonfüred, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Ulhasnagar, , India

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Hadera, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Alkmaar, , Netherlands

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Arnhem, , Netherlands

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Breda, , Netherlands

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Eindhoven, , Netherlands

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Uden, , Netherlands

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Zutphen, , Netherlands

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Bloemfontein, , South Africa

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George, , South Africa

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Pretoria, , South Africa

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Somerset West, , South Africa

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Alcobendas, , Spain

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Badalona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Málaga, , Spain

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Pamplona, , Spain

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Pozuelo de Alarcón, , Spain

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Santiago de Compostela, , Spain

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Belfast, , United Kingdom

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Bristol, , United Kingdom

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Corby, , United Kingdom

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Hayle, , United Kingdom

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Hull, , United Kingdom

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London, , United Kingdom

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Northwood, , United Kingdom

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Orpington, , United Kingdom

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Shipley, , United Kingdom

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Wythenshawe, , United Kingdom

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Countries

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United States Argentina Belgium Canada Colombia France Hungary India Israel Netherlands Poland South Africa Spain United Kingdom

References

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Thach T, Dhanabalan K, Nandekar PP, Stauffer S, Heisler I, Alvarado S, Snyder J, Subramanian R. Mechanistic insights into the selective targeting of P2X3 receptor by camlipixant antagonist. J Biol Chem. 2025 Jan;301(1):108109. doi: 10.1016/j.jbc.2024.108109. Epub 2024 Dec 18.

Reference Type DERIVED
PMID: 39706278 (View on PubMed)

Other Identifiers

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BUS-P3-01

Identifier Type: OTHER

Identifier Source: secondary_id

2024-513460-26-00

Identifier Type: OTHER

Identifier Source: secondary_id

221850

Identifier Type: -

Identifier Source: org_study_id

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