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

NCT05600777 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 221851BUS-P3-022024-513462-19-00
• Study Type: interventional
• Target: 975
• Locations: 13 countries
• Sites: 252

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 24

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24

  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 24

• Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24

  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 24

• Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24

  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 24

• Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24

  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 24

• Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24

  Baseline, Week 24

• Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24

  Baseline, Week 24

• Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24

  Baseline, Week 24

• Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24

  Baseline, Week 24

• Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24

  Baseline, Week 24

• Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 24

  Baseline, Week 24

• Change from Baseline in Male Reproductive Hormones: Follicle-Stimulating Hormone [FSH] and Luteinizing Hormone [LH] (international units per liter [IU/L]) at Week 24

  Baseline, Week 24

• Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 24

  Baseline, Week 24

• Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 24

  Baseline, Week 24

• Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 24

  Baseline, Week 24

• Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 24

  Baseline, Week 24

• Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 24

  Baseline, Week 24

• Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 24

  Baseline, Week 24

• Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 24

  Baseline, Week 24

• 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 24

  Baseline, Week 24

• 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 24

  Baseline, Week 24

• Change from Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase (ALP) and Creatine Kinase (CK) (international units per liter [IU/L]) at Week 24

  Baseline, Week 24

• Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 24

  Baseline, Week 24

• 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 24

  Baseline, Week 24

• Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 24

  Baseline, Week 24

• 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 24

  Baseline, Week 24

• Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 24

  Baseline, Week 24

• Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 24

  Baseline, Week 24

• 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 24

  Baseline, Week 24

Secondary Outcomes (8)

• Change from Baseline in Cough Severity Visual Analogue Scale at Week 24

  Baseline, Week 24

• Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analog Scale at Week 24

  Baseline, Week 24

• Awake Cough Frequency at Week 24

  Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

Placebo DRUG

Oral administration of matching placebo for BLU-5937 Tablets

Placebo

BLU-5937 DRUG

Oral administration of BLU-5937 Tablets

Also known as: Camlipixant

BLU-5937 25 mg; BLU-5937 50 mg

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 (252)

GSK Investigational Site

Foley, Alabama, 36535, United States

Location

GSK Investigational Site

Litchfield Park, Arizona, 85340, United States

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GSK Investigational Site

Phoenix, Arizona, 85032, United States

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GSK Investigational Site

Los Angeles, California, 90025, United States

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GSK Investigational Site

Los Angeles, California, 90048, United States

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GSK Investigational Site

Paramount, California, 90723, United States

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GSK Investigational Site

Redding, California, 96001, United States

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GSK Investigational Site

Sacramento, California, 95661, United States

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GSK Investigational Site

San Diego, California, 92108, United States

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GSK Investigational Site

San Diego, California, 92120, United States

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GSK Investigational Site

San Jose, California, 95117, 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

Denver, Colorado, 80230, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

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Daytona Beach, Florida, 32117, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33324, United States

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GSK Investigational Site

Jacksonville, Florida, 32224, United States

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GSK Investigational Site

Leesburg, Florida, 34748, United States

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GSK Investigational Site

Orlando, Florida, 32713, United States

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GSK Investigational Site

Santa Rosa Beach, Florida, 32459, United States

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GSK Investigational Site

Sarasota, Florida, 34239, United States

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GSK Investigational Site

Sweetwater, Florida, 33172, United States

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GSK Investigational Site

Cumming, Georgia, 30041, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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GSK Investigational Site

River Forest, Illinois, 60305, United States

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GSK Investigational Site

West Des Moines, Iowa, 50266, United States

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GSK Investigational Site

Lexington, Kentucky, 40509, United States

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GSK Investigational Site

Chevy Chase, Maryland, 20815, United States

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GSK Investigational Site

Methuen, Massachusetts, 03801, United States

Location

GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

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GSK Investigational Site

Ypsilanti, Michigan, 48197, United States

Location

GSK Investigational Site

Edina, Minnesota, 55435, United States

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GSK Investigational Site

Rochester, Minnesota, 55905, United States

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GSK Investigational Site

Woodbury, Minnesota, 55125, 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

Omaha, Nebraska, 68124, United States

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GSK Investigational Site

Charlotte, North Carolina, 28211, United States

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GSK Investigational Site

Gastonia, North Carolina, 28054, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

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GSK Investigational Site

Columbus, Ohio, 43235, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74136, United States

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GSK Investigational Site

Portland, Oregon, 97213, United States

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GSK Investigational Site

Danville, Pennsylvania, 17822, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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GSK Investigational Site

Warwick, Rhode Island, 02886, United States

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GSK Investigational Site

Anderson, South Carolina, 29621, United States

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GSK Investigational Site

Charleston, South Carolina, 29406, United States

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GSK Investigational Site

Charleston, South Carolina, 29412, United States

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GSK Investigational Site

Franklin, Tennessee, 37067, United States

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GSK Investigational Site

Dallas, Texas, 75231-4307, United States

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GSK Investigational Site

San Antonio, Texas, 78207, United States

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GSK Investigational Site

San Antonio, Texas, 78258, United States

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GSK Investigational Site

Norfolk, Virginia, 23507, United States

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GSK Investigational Site

Bellingham, Washington, 98225, United States

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GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia

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GSK Investigational Site

Macquarie University, New South Wales, 2109, Australia

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GSK Investigational Site

New Lambton Heights, New South Wales, 2305, Australia

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GSK Investigational Site

St Leonards, New South Wales, 2065, Australia

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GSK Investigational Site

Chermside, Queensland, 4032, Australia

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GSK Investigational Site

Adelaide, South Australia, 5000, Australia

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GSK Investigational Site

St Albans, Victoria, 3021, Australia

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GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

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GSK Investigational Site

Spearwood, Western Australia, 6163, Australia

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GSK Investigational Site

Calgary, Alberta, T2N 1N4, Canada

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GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

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GSK Investigational Site

Hamilton, Ontario, L8L 5G4, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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GSK Investigational Site

Toronto, Ontario, M5T 3A9, Canada

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Windsor, Ontario, N8X 1T3, Canada

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Montreal, Quebec, H1Y3H5, Canada

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Québec, Quebec, G1V 4T3, Canada

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Québec, Quebec, G1V 4W2, Canada

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

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Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Victoriaville, Quebec, G6P 3Z8, Canada

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GSK Investigational Site

Burlington, ON L7N 3V2, Canada

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GSK Investigational Site

Leshan, Sichuan, 614003, China

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GSK Investigational Site

Beijing, 100730, China

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GSK Investigational Site

Changsha, 410008, China

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GSK Investigational Site

Chengdu, 610021, China

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GSK Investigational Site

Chengdu, 610041, China

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GSK Investigational Site

Chongqing, 408099, China

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GSK Investigational Site

Dongguan, 523326, China

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GSK Investigational Site

Ganzhou, 341000, China

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GSK Investigational Site

Guangzhou, 510000, China

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GSK Investigational Site

Guangzhou, 510260, China

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GSK Investigational Site

Guilin, 541002, China

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GSK Investigational Site

Hangzhou, 310003, China

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GSK Investigational Site

Hefei, 230001, China

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GSK Investigational Site

Hefei, 230022, China

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GSK Investigational Site

Hohhot, 010017, China

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GSK Investigational Site

Huizhou, 516000, China

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GSK Investigational Site

Huizhou, 516001, China

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GSK Investigational Site

Jiangsu, 221004, China

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GSK Investigational Site

Jinan, 250021, China

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GSK Investigational Site

Kunming, 650032, China

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GSK Investigational Site

Liuchow, China

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GSK Investigational Site

Meizhou, 514700, China

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GSK Investigational Site

Nanchang, 330038, China

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GSK Investigational Site

Pingxiang, 337055, China

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GSK Investigational Site

Shanghai, 200032, China

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GSK Investigational Site

Shanghai, 200065, China

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GSK Investigational Site

Shanghai, 200080, China

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GSK Investigational Site

Shenyang, 110004, China

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GSK Investigational Site

Shenzhen, 518053, China

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GSK Investigational Site

Taizhou, 317000, China

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GSK Investigational Site

Ürümqi, 830001, China

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GSK Investigational Site

Weifang, China

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GSK Investigational Site

Wuxi, 214023, China

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GSK Investigational Site

Xiamen, 361004, China

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GSK Investigational Site

Yangzhou, 225001, China

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GSK Investigational Site

Yinchuan, China

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GSK Investigational Site

Zhanjiang, 524045, China

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GSK Investigational Site

Zhengzhou, 450052, China

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GSK Investigational Site

Brandýs nad Labem, 25001, Czechia

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GSK Investigational Site

Brno, 62500, Czechia

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GSK Investigational Site

Kralupy nad Vltavou, 278 01, Czechia

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GSK Investigational Site

Miroslav, 671 72, Czechia

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GSK Investigational Site

Olomouc, 77900, Czechia

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GSK Investigational Site

Prague, 14800, Czechia

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GSK Investigational Site

Strakonice, 38601, Czechia

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GSK Investigational Site

Berlin, 10117, Germany

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GSK Investigational Site

Berlin, 10969, Germany

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GSK Investigational Site

Bochum, 44787, Germany

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GSK Investigational Site

Darmstadt, 64283, Germany

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GSK Investigational Site

Dresden, 01069, Germany

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GSK Investigational Site

Essen, 45355, Germany

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GSK Investigational Site

Frankfurt, 60590, Germany

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GSK Investigational Site

Frankfurt, 60596, Germany

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GSK Investigational Site

Frankfurt am Main, 60315, Germany

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GSK Investigational Site

Geesthacht, 21502, Germany

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GSK Investigational Site

Halle, 6108, Germany

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Hamburg, 20253, Germany

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GSK Investigational Site

Hanover, 30159, Germany

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Hanover, 30173, Germany

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Heidelberg, 69126, Germany

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GSK Investigational Site

Karlsruhe, 76137, Germany

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GSK Investigational Site

Lübeck, 23552, Germany

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GSK Investigational Site

Marburg, 35037, Germany

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München, 81241, Germany

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GSK Investigational Site

Neu-Isenburg, 63263, Germany

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GSK Investigational Site

Peine, 31224, Germany

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GSK Investigational Site

Schleswig, 24837, Germany

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GSK Investigational Site

Wallerfing, 94574, Germany

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GSK Investigational Site

Belagavi, 590010, India

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GSK Investigational Site

Faridabad, 121006, India

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GSK Investigational Site

Nagpur, 44009, India

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GSK Investigational Site

Nashik, 422001, India

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GSK Investigational Site

Visakhapatnam, 530017, India

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GSK Investigational Site

Aichi, 460-0001, Japan

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GSK Investigational Site

Aichi, 467-8602, Japan

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GSK Investigational Site

Akita, 010-8543, Japan

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GSK Investigational Site

Chiba, 260-8677, Japan

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GSK Investigational Site

Fukui, 910-1193, Japan

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GSK Investigational Site

Fukuoka, 807-8556, Japan

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GSK Investigational Site

Fukuoka, 812-8582, Japan

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GSK Investigational Site

Fukuoka, 819-8555, Japan

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GSK Investigational Site

Fukushima, 960-1295, Japan

Location

GSK Investigational Site

Gifu, 153-8515, Japan

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GSK Investigational Site

Gifu, 501-6062, Japan

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GSK Investigational Site

Gifu, 509-6134, Japan

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GSK Investigational Site

Hiroshima, 730-0853, Japan

Location

GSK Investigational Site

Hiroshima, 735-8585, Japan

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GSK Investigational Site

Hokkaido, 064-0804, Japan

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GSK Investigational Site

Hyōgo, 663-8501, Japan

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GSK Investigational Site

Hyōgo, 670-8520, Japan

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GSK Investigational Site

Hyōgo, 672-8064, Japan

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GSK Investigational Site

Hyōgo, 674-0063, Japan

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GSK Investigational Site

Ibaraki, 319-1113, Japan

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GSK Investigational Site

Kagawa, 761-8073, Japan

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GSK Investigational Site

Kagoshima, 890-8520, Japan

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Kanagawa, 231-8682, Japan

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GSK Investigational Site

Kanagawa, 232-0024, Japan

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GSK Investigational Site

Kanagawa, 234-8503, Japan

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GSK Investigational Site

Kyoto, 606-8507, Japan

Location

GSK Investigational Site

Kyoto, 612-8555, Japan

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GSK Investigational Site

Mie, 515-8544, Japan

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GSK Investigational Site

Miyazaki, 889-4304, Japan

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GSK Investigational Site

Nagasaki, 852-8501, Japan

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GSK Investigational Site

Nankoku-shi, 783-8509, Japan

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GSK Investigational Site

Niigata, 950-1197, Japan

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GSK Investigational Site

Osaka, 545-8586, Japan

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GSK Investigational Site

Osaka, 577-0843, Japan

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GSK Investigational Site

Osaka, 589-8511, Japan

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GSK Investigational Site

Osaka, 591-8555, Japan

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GSK Investigational Site

Saitama, 350-0495, Japan

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GSK Investigational Site

Shizuoka, 420-8527, Japan

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GSK Investigational Site

Shizuoka, 426-8677, Japan

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GSK Investigational Site

Shizuoka, 432-8002, Japan

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GSK Investigational Site

Shizuoka, 433-8558, Japan

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Tochigi, 321-0293, Japan

Location

GSK Investigational Site

Tokyo, 104-0031, Japan

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GSK Investigational Site

Tokyo, 140-8522, Japan

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GSK Investigational Site

Tokyo, 150-8935, Japan

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GSK Investigational Site

Tokyo, 173-8606, Japan

Location

GSK Investigational Site

Tokyo, 204-8522, Japan

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GSK Investigational Site

Toyama, 930-8550, Japan

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GSK Investigational Site

Yokohama, 236-0004, Japan

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GSK Investigational Site

Havelock North, Hawke's Bay Region, 3410, New Zealand

Location

GSK Investigational Site

Auckland, 0626, New Zealand

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GSK Investigational Site

Christchurch, 8011, New Zealand

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GSK Investigational Site

Christchurch, 8013, New Zealand

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GSK Investigational Site

Dunedin, 9016, New Zealand

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GSK Investigational Site

Ebdentown, 5018, New Zealand

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GSK Investigational Site

Hamilton, 3200, New Zealand

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GSK Investigational Site

Kapiti, 5036, New Zealand

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GSK Investigational Site

Nelson, 7011, New Zealand

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GSK Investigational Site

Rotorua, 3010, New Zealand

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GSK Investigational Site

Bardejov, 08501, Slovakia

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GSK Investigational Site

Bardejov, 8501, Slovakia

Location

GSK Investigational Site

Humenné, 06601, Slovakia

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GSK Investigational Site

Kežmarok, 060 01, Slovakia

Location

GSK Investigational Site

Košice, 040 01, Slovakia

Location

GSK Investigational Site

Prievidza, 97101, Slovakia

Location

GSK Investigational Site

Spišská Nová Ves, 052 01, Slovakia

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GSK Investigational Site

Busan, 49241, South Korea

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GSK Investigational Site

Incheon, 21431, South Korea

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GSK Investigational Site

Jeonju, 54907, South Korea

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GSK Investigational Site

Seongnam, 13620, South Korea

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GSK Investigational Site

Seoul, 03080, South Korea

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GSK Investigational Site

Seoul, 03312, South Korea

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GSK Investigational Site

Seoul, 03722, South Korea

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GSK Investigational Site

Seoul, 06591, South Korea

Location

GSK Investigational Site

Seoul, 08308, South Korea

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GSK Investigational Site

Seoul, 133-792, South Korea

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GSK Investigational Site

Seoul, 5030, South Korea

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GSK Investigational Site

Seoul, 5505, South Korea

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GSK Investigational Site

Seoul, 6351, South Korea

Location

GSK Investigational Site

Wŏnju, 26426, South Korea

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GSK Investigational Site

Changhua, 50006, Taiwan

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GSK Investigational Site

Kaohsiung City, 807, Taiwan

Location

GSK Investigational Site

Kaohsiung City, 82445, Taiwan

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GSK Investigational Site

Taoyuan, 333, Taiwan

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GSK Investigational Site

Belfast, BT7 2EB, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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GSK Investigational Site

Bristol, BS374AX, United Kingdom

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GSK Investigational Site

Chelmsford, CM1 7ET, United Kingdom

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GSK Investigational Site

Corby, NN17 2UR, United Kingdom

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GSK Investigational Site

Corby, NN18 9EZ, United Kingdom

Location

GSK Investigational Site

Coventry, CV3 4FJ, United Kingdom

Location

GSK Investigational Site

Hayle, TR27 5DT, United Kingdom

Location

GSK Investigational Site

Hull, HU16 5JQ, United Kingdom

Location

GSK Investigational Site

London, SE5 9RS, United Kingdom

Location

GSK Investigational Site

Northwood, HA6 2RN, United Kingdom

Location

GSK Investigational Site

Orpington, BR5 3QG, United Kingdom

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GSK Investigational Site

Peterborough, PE3 9GZ, United Kingdom

Location

GSK Investigational Site

Preston, PR2 9HT, United Kingdom

Location

GSK Investigational Site

Shipley, BD18 3SA, United Kingdom

Location

GSK Investigational Site

Tyne and Wear, NE29 8NH, United Kingdom

Location

GSK Investigational Site

Wishaw, ML2 0DP, United Kingdom

Location

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: December 5, 2022
• Primary Completion (Estimated): June 11, 2026
• Study Completion (Estimated): March 17, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13); CN (38); TW (4); GB (17); IN (5); CZ (7); DE (23); JP (49); SL (7); US (56); AU (9); NZ (10); KR (14)