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

NCT05599191 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 221850BUS-P3-012024-513460-26-00
• Study Type: interventional
• Target: 825
• Locations: 14 countries
• Sites: 191

Brief Summary

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

Conditions

Cough; Refractory Chronic Cough

Keywords

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Cough; Chronic Cough

Outcome Measures

Primary Outcomes (29)

• 24-Hour Cough Frequency

  Assessed using an ambulatory cough monitor

  Week 12

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

  Up to Week 52

• Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 52

  An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.

  Up to Week 52

• Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 52

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

  Up to Week 52

• Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 52

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

  Up to Week 52

• Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52

  Baseline, Week 52

• Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52

  Baseline, Week 52

• Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52

  Baseline, Week 52

• Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52

  Baseline, Week 52

• Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 52

  Baseline, Week 52

• Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Male Reproductive Hormones: Follicle-Stimulating Hormone [FSH] and Luteinizing Hormone [LH] (international units per liter [IU/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52

  Baseline, Week 52

• Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52

  Baseline, Week 52

• Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 52

  Baseline, Week 52

• Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 52

  Baseline, Week 52

• Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52

  Baseline, Week 52

• Change from Baseline in Hematology Parameters: White Blood Cell (WBC) Count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and Platelet Count (10^9 cells per liter) at Week 52

  Baseline, Week 52

• Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-Glutamyl Transferase (GGT) (units per liter [U/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase (ALP) and Creatine Kinase (CK) (international units per liter [IU/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 52

  Baseline, Week 52

• Change from Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Calcium, Magnesium, Bicarbonate, Glucose, and Blood Urea Nitrogen (BUN) (millimoles per liter [mmol/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 52

  Baseline, Week 52

• Change from Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) (milliliters per minute per 1.73 meters squared [mL/min/1.73 m^2]) at Week 52

  Baseline, Week 52

• Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 52

  Baseline, Week 52

• Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 52

  Baseline, Week 52

• Change from Baseline in ECG Value: PR Interval, QT Interval, RR Interval, QRS Interval, and Corrected QT Interval Using Fridericia's Formula (QTcF) (milliseconds) at Week 52

  Baseline, Week 52

Secondary Outcomes (8)

• Change from Baseline in Cough Severity Visual Analogue Scale at Week 12

  Baseline, Week 12

• Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analogue Scale at Week 12

  Baseline, Week 12

• Awake Cough Frequency at Week 12

  Week 12

• Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 12

  Baseline, Week 12

• Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12

  Baseline, Week 12

Study Arms (3)

BLU-5937 25 mg

EXPERIMENTAL

BLU-5937 oral dose 25 mg twice a day.

Drug: BLU-5937

BLU-5937 50 mg

EXPERIMENTAL

BLU-5937 oral dose 50 mg twice a day.

Drug: BLU-5937

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BLU-5937 DRUG

Oral administration of BLU-5937 Tablets

Also known as: Camlipixant

BLU-5937 25 mg; BLU-5937 50 mg

Placebo DRUG

Oral administration of matching placebo for BLU-5937 Tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (191)

GSK Investigational Site

Litchfield Park, Arizona, 85340, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85248, United States

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GSK Investigational Site

Encinitas, California, 92024, United States

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GSK Investigational Site

Mission Viejo, California, 92691, United States

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GSK Investigational Site

Paramount, California, 90723, United States

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GSK Investigational Site

Roseville, California, 95661, United States

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GSK Investigational Site

Aurora, Colorado, 80012, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80923, United States

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GSK Investigational Site

Clearwater, Florida, 33756, United States

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GSK Investigational Site

Gainesville, Florida, 32608, United States

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GSK Investigational Site

Miami, Florida, 15801, United States

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GSK Investigational Site

Miami, Florida, 33155, United States

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GSK Investigational Site

Miami, Florida, 33173, United States

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GSK Investigational Site

Miami, Florida, 33186, United States

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GSK Investigational Site

Orlando, Florida, 32713, United States

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GSK Investigational Site

Lawrenceville, Georgia, 30046, United States

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GSK Investigational Site

Normal, Illinois, 61761, United States

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GSK Investigational Site

Oak Lawn, Illinois, 60453, United States

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GSK Investigational Site

Ames, Iowa, 50010, United States

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GSK Investigational Site

Iowa City, Iowa, 52242, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66160, United States

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GSK Investigational Site

Topeka, Kansas, 66606, United States

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GSK Investigational Site

Wichita, Kansas, 67214, United States

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GSK Investigational Site

Crowley, Louisiana, 70526, United States

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GSK Investigational Site

Shreveport, Louisiana, 71115, United States

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GSK Investigational Site

Annapolis, Maryland, 21404, United States

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GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

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GSK Investigational Site

Ypsilanti, Michigan, 48197, United States

Location

GSK Investigational Site

Columbia, Missouri, 65203, United States

Location

GSK Investigational Site

St Louis, Missouri, 63110, United States

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GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

Missoula, Montana, 59808, United States

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GSK Investigational Site

Jersey City, New Jersey, 07304, United States

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GSK Investigational Site

The Bronx, New York, 10461, United States

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GSK Investigational Site

Charlotte, North Carolina, 28277, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 28401, United States

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GSK Investigational Site

Rocky Mount, North Carolina, 27804, United States

Location

GSK Investigational Site

Salisbury, North Carolina, 28144, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Columbus, Ohio, 43215, United States

Location

GSK Investigational Site

Dayton, Ohio, 45417, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Portland, Oregon, 97202, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

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GSK Investigational Site

Warwick, Rhode Island, 02886, United States

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GSK Investigational Site

Charleston, South Carolina, 29406, United States

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GSK Investigational Site

Little River, South Carolina, 29566, United States

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GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

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GSK Investigational Site

Rock Hill, South Carolina, 29732, United States

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GSK Investigational Site

Bristol, Tennessee, 37620, United States

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GSK Investigational Site

Knoxville, Tennessee, 37938, United States

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GSK Investigational Site

Dallas, Texas, 75231-4307, United States

Location

GSK Investigational Site

Houston, Texas, 77074, United States

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GSK Investigational Site

Houston, Texas, 77401, United States

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GSK Investigational Site

McKinney, Texas, 75069, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Waco, Texas, 76712, United States

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GSK Investigational Site

Salt Lake City, Utah, 84132, United States

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GSK Investigational Site

Norfolk, Virginia, 23507, United States

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GSK Investigational Site

Williamsburg, Virginia, 23188, United States

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GSK Investigational Site

Bellevue, Washington, 68123, United States

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GSK Investigational Site

Bellingham, Washington, 98225, United States

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GSK Investigational Site

Buenos Aires, C1406AGA, Argentina

Location

GSK Investigational Site

Buenos Aires, C199AAB, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1128AAF, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1027AAP, Argentina

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GSK Investigational Site

Córdoba, X5003DCE, Argentina

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GSK Investigational Site

Mar del Plata, B7600FYK, Argentina

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GSK Investigational Site

Mendoza, 5500, Argentina

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GSK Investigational Site

Rosario, S2000DBS, Argentina

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GSK Investigational Site

Rosario, S2000DEJ, Argentina

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GSK Investigational Site

Rosario, S2002OJN, Argentina

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GSK Investigational Site

San Miguel de Tucumán, T4000IAI, Argentina

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GSK Investigational Site

Santa Fe, 3000, Argentina

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GSK Investigational Site

Vicente López, 1602, Argentina

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Kortrijk, 8500, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Liège, 4000, Belgium

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GSK Investigational Site

Mechelen, 2800, Belgium

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GSK Investigational Site

Roeselare, 8800, Belgium

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GSK Investigational Site

Calgary, Alberta, T2T 5C7, Canada

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GSK Investigational Site

Calgary, Alberta, T3E 7M8, Canada

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GSK Investigational Site

Kelowna, British Columbia, V1Y3H5, Canada

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GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

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GSK Investigational Site

Hamilton, Ontario, L8M 1K7, Canada

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GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

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GSK Investigational Site

Toronto, Ontario, M5T 3A9, Canada

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GSK Investigational Site

Windsor, Ontario, N8X 1T3, Canada

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GSK Investigational Site

Greenfield Park, Quebec, J4V 2H1, Canada

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GSK Investigational Site

Montreal, Quebec, H1M 1B1, Canada

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GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

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GSK Investigational Site

Québec, Quebec, G1N 4V3, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4G5, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4W2, Canada

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GSK Investigational Site

Québec, Quebec, G3K 2P8, Canada

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GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Victoriaville, Quebec, G6P 6P6, Canada

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GSK Investigational Site

Burlington, ON L7N 3V2, Canada

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GSK Investigational Site

Floridablanca, 681004, Colombia

Location

GSK Investigational Site

Medellín, 00000, Colombia

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GSK Investigational Site

Medellín, 050034, Colombia

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GSK Investigational Site

Medellín, 50021, Colombia

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GSK Investigational Site

Dijon, 21079, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Marseille, 13003, France

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GSK Investigational Site

Marseille, 13015, France

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GSK Investigational Site

Montpellier, 34295, France

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GSK Investigational Site

Paris, 75014, France

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GSK Investigational Site

Strasbourg, 67091, France

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GSK Investigational Site

Toulouse, 31000, France

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GSK Investigational Site

Balatonfüred, 8230, Hungary

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GSK Investigational Site

Budapest, 1027, Hungary

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GSK Investigational Site

Budapest, 1033, Hungary

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GSK Investigational Site

Gödöllő, 2100, Hungary

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GSK Investigational Site

Hajdúnánás, 4080, Hungary

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GSK Investigational Site

Mosonmagyaróvár, 9300, Hungary

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GSK Investigational Site

Pécs, 7635, Hungary

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GSK Investigational Site

Püspökladány, 4150, Hungary

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GSK Investigational Site

Aurangabad, 431003, India

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GSK Investigational Site

Bengaluru, 560068, India

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GSK Investigational Site

Delhi, 110076, India

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GSK Investigational Site

Jaipur, 302023, India

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GSK Investigational Site

Kolkata, 700027, India

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GSK Investigational Site

Kozhikode, 673008, India

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GSK Investigational Site

Nashik, 422007, India

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GSK Investigational Site

Nashik, 422009, India

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GSK Investigational Site

Pune, 411004, India

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GSK Investigational Site

Rohtak, 124514, India

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GSK Investigational Site

Thane, 401107, India

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GSK Investigational Site

Ulhasnagar, 421001, India

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GSK Investigational Site

Hadera, 169, Israel

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GSK Investigational Site

Haifa, 3436212, Israel

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GSK Investigational Site

Jerusalem, 9112001, Israel

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GSK Investigational Site

Petah Tikva, 4941492, Israel

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GSK Investigational Site

Ramat Gan, 52621, Israel

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GSK Investigational Site

Tel Aviv, 64239, Israel

Location

GSK Investigational Site

Alkmaar, 1815 JD, Netherlands

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GSK Investigational Site

Arnhem, 6815 AD, Netherlands

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GSK Investigational Site

Breda, 4818 CK, Netherlands

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GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

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GSK Investigational Site

Uden, 5406 PT, Netherlands

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GSK Investigational Site

Zutphen, 7207 AE, Netherlands

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GSK Investigational Site

Zwolle, 8025 AB, Netherlands

Location

GSK Investigational Site

Bialystok, 15-010, Poland

Location

GSK Investigational Site

Bydgoszcz, 85-079, Poland

Location

GSK Investigational Site

Bydgoszcz, 85-796, Poland

Location

GSK Investigational Site

Lodz, 90-141, Poland

Location

GSK Investigational Site

Lodz, 90-153, Poland

Location

GSK Investigational Site

Ostrowiec Świętokrzyski, 27-400, Poland

Location

GSK Investigational Site

Piaseczno, 05-500, Poland

Location

GSK Investigational Site

Rzeszów, 35-051, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Zawadzkie, 47-120, Poland

Location

GSK Investigational Site

Bloemfontein, 9301, South Africa

Location

GSK Investigational Site

Durban, 4001, South Africa

Location

GSK Investigational Site

Durban, 4093, South Africa

Location

GSK Investigational Site

George, 6529, South Africa

Location

GSK Investigational Site

Johannesburg, 1501, South Africa

Location

GSK Investigational Site

Johannesburg, 2060, South Africa

Location

GSK Investigational Site

Pretoria, 0122, South Africa

Location

GSK Investigational Site

Somerset West, 7130, South Africa

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GSK Investigational Site

Alcobendas, 28100, Spain

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GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08017, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Granada, 18014, Spain

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GSK Investigational Site

Madrid, 28006, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Málaga, 29004, Spain

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GSK Investigational Site

Málaga, 29010, Spain

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GSK Investigational Site

Pamplona, 31008, Spain

Location

GSK Investigational Site

Pozuelo de Alarcón, 28223, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Belfast, BT9 7AB, United Kingdom

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GSK Investigational Site

Bristol, BS374AX, United Kingdom

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GSK Investigational Site

Corby, NN17 2UR, United Kingdom

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GSK Investigational Site

Hayle, TR27 5DT, United Kingdom

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GSK Investigational Site

Hull, HU12 8JD, United Kingdom

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GSK Investigational Site

London, SW3 6HP, United Kingdom

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GSK Investigational Site

Northwood, HA6 2RN, United Kingdom

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GSK Investigational Site

Orpington, BR5 3QG, United Kingdom

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GSK Investigational Site

Shipley, BD18 3SA, United Kingdom

Location

GSK Investigational Site

Wythenshawe, M23 9LT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39706278 DERIVED

MeSH Terms

Conditions

Cough; Chronic Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Interventions

BLU-5937

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 31, 2022
• Study Start: October 25, 2022
• Primary Completion: December 18, 2025
• Study Completion (Estimated): May 28, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8); IL (6); IN (12); PL (10); NL (7); AR (13); US (65); CA (20); HU (8); ZA (8); BE (7); GB (10); ES (13); CO (4)