A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-1)

A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cough; Refractory Chronic Cough
• Intervention / Treatment: Drug: BLU-5937; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 825
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1128AAF
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1027AAP
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aires, Argentina, C1406AGA
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aires, Argentina, C199AAB
    • GSK Investigational Site
  • Cordoba, Argentina, X5003DCE
    • GSK Investigational Site
  • Mar del Plata, Argentina, B7600FYK
    • GSK Investigational Site
  • Mendoza, Argentina, 5500
    • GSK Investigational Site
  • Rosario, Argentina, S2000DBS
    • GSK Investigational Site
  • Rosario, Argentina, S2002OJN
    • GSK Investigational Site
  • Rosario, Argentina, S2000DEJ
    • GSK Investigational Site
  • San Miguel de Tucuman, Argentina, T4000IAI
    • GSK Investigational Site
  • Santa Fe, Argentina, 3000
    • GSK Investigational Site
  • Vicente Lopez, Argentina, 1602
    • GSK Investigational Site
• Belgium
  • Bruxelles, Belgium, 1200
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Kortrijk, Belgium, 8500
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • LiEge, Belgium, 4000
    • GSK Investigational Site
  • Mechelen, Belgium, 2800
    • GSK Investigational Site
  • Roeselare, Belgium, 8800
    • GSK Investigational Site
• Canada
  • Burlington, Canada, ON L7N 3V2
    • GSK Investigational Site
  • Quebec, Canada, G3K 2P8
    • GSK Investigational Site
  • Quebec, Canada, G1V 4G5
    • GSK Investigational Site
  • Quebec, Canada, G1N 4V3
    • GSK Investigational Site
  • Quebec, Canada, G1V 4W2
    • GSK Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • GSK Investigational Site
    • Calgary, Alberta, Canada, T3E 7M8
      • GSK Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y3H5
      • GSK Investigational Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • GSK Investigational Site
    • Hamilton, Ontario, Canada, L8N 3Z5
      • GSK Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5T 3A9
      • GSK Investigational Site
    • Windsor, Ontario, Canada, N8X 1T3
      • GSK Investigational Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H4A 3J1
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H1M 1B1
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • GSK Investigational Site
    • St-Charles-Borromee, Quebec, Canada, J6E 2B4
      • GSK Investigational Site
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • GSK Investigational Site
    • Victoriaville, Quebec, Canada, G6P 6P6
      • GSK Investigational Site
• Colombia
  • Floridablanca, Colombia, 681004
    • GSK Investigational Site
  • Medellin, Colombia, 050034
    • GSK Investigational Site
  • Medellin, Colombia, 00000
    • GSK Investigational Site
  • Medellin, Colombia, 50021
    • GSK Investigational Site
• France
  • Dijon, France, 21079
    • GSK Investigational Site
  • Lille Cedex, France, 59037
    • GSK Investigational Site
  • Marseille, France, 13003
    • GSK Investigational Site
  • Marseille, France, 13015
    • GSK Investigational Site
  • Montpellier cedex 5, France, 34295
    • GSK Investigational Site
  • Paris, France, 75014
    • GSK Investigational Site
  • Strasbourg, France, 67091
    • GSK Investigational Site
  • Toulouse, France, 31000
    • GSK Investigational Site
• Hungary
  • Balatonfured, Hungary, 8230
    • GSK Investigational Site
  • Budapest, Hungary, 1033
    • GSK Investigational Site
  • Budapest, Hungary, 1027
    • GSK Investigational Site
  • Godollo, Hungary, 2100
    • GSK Investigational Site
  • Hajdunanas, Hungary, 4080
    • GSK Investigational Site
  • Mosonmagyarovar, Hungary, 9300
    • GSK Investigational Site
  • Pecs, Hungary, 7635
    • GSK Investigational Site
  • Puspokladany, Hungary, 4150
    • GSK Investigational Site
• India
  • Aurangabad, India, 431003
    • GSK Investigational Site
  • Bengaluru, India, 560068
    • GSK Investigational Site
  • Delhi, India, 110076
    • GSK Investigational Site
  • Jaipur, India, 302023
    • GSK Investigational Site
  • Kolkata, India, 700027
    • GSK Investigational Site
  • Kozhikode, India, 673008
    • GSK Investigational Site
  • Nashik, India, 422007
    • GSK Investigational Site
  • Nashik, India, 422009
    • GSK Investigational Site
  • Pune, India, 411004
    • GSK Investigational Site
  • Rohtak, India, 124514
    • GSK Investigational Site
  • Thane, India, 401107
    • GSK Investigational Site
  • Ulhasnagar, India, 421001
    • GSK Investigational Site
• Israel
  • Hadera, Israel, 169
    • GSK Investigational Site
  • Haifa, Israel, 3436212
    • GSK Investigational Site
  • Jerusalem, Israel, 9112001
    • GSK Investigational Site
  • Petach Tikva, Israel, 4941492
    • GSK Investigational Site
  • Ramat Gan, Israel, 52621
    • GSK Investigational Site
  • Tel Aviv, Israel, 64239
    • GSK Investigational Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • GSK Investigational Site
  • Arnhem, Netherlands, 6815 AD
    • GSK Investigational Site
  • Breda, Netherlands, 4818 CK
    • GSK Investigational Site
  • Eindhoven, Netherlands, 5623 EJ
    • GSK Investigational Site
  • Uden, Netherlands, 5406 PT
    • GSK Investigational Site
  • Zutphen, Netherlands, 7207 AE
    • GSK Investigational Site
  • Zwolle, Netherlands, 8025 AB
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-010
    • GSK Investigational Site
  • Bydgoszcz, Poland, 85-796
    • GSK Investigational Site
  • Bydgoszcz, Poland, 85-079
    • GSK Investigational Site
  • Lodz, Poland, 90-153
    • GSK Investigational Site
  • Lodz, Poland, 90-141
    • GSK Investigational Site
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • GSK Investigational Site
  • Piaseczno, Poland, 05-500
    • GSK Investigational Site
  • Rzeszow, Poland, 35-051
    • GSK Investigational Site
  • Tarnow, Poland, 33-100
    • GSK Investigational Site
  • Zawadzkie, Poland, 47-120
    • GSK Investigational Site
• South Africa
  • Bloemfontein, South Africa, 9301
    • GSK Investigational Site
  • Durban, South Africa, 4001
    • GSK Investigational Site
  • Durban, South Africa, 4093
    • GSK Investigational Site
  • George, South Africa, 6529
    • GSK Investigational Site
  • Johannesburg, South Africa, 1501
    • GSK Investigational Site
  • Johannesburg, South Africa, 2060
    • GSK Investigational Site
  • Pretoria, South Africa, 0122
    • GSK Investigational Site
  • Somerset West, South Africa, 7130
    • GSK Investigational Site
• Spain
  • Alcobendas, Spain, 28100
    • GSK Investigational Site
  • Badalona, Spain, 08916
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08017
    • GSK Investigational Site
  • Granada, Spain, 18014
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Madrid, Spain, 28007
    • GSK Investigational Site
  • Malaga, Spain, 29010
    • GSK Investigational Site
  • Malaga, Spain, 29004
    • GSK Investigational Site
  • Pamplona, Spain, 31008
    • GSK Investigational Site
  • Pozuelo de Alarcon, Spain, 28223
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • GSK Investigational Site
  • Bristol, United Kingdom, BS374AX
    • GSK Investigational Site
  • Corby, United Kingdom, NN17 2UR
    • GSK Investigational Site
  • Hayle, United Kingdom, TR27 5DT
    • GSK Investigational Site
  • Hull, United Kingdom, HU12 8JD
    • GSK Investigational Site
  • London, United Kingdom, SW3 6HP
    • GSK Investigational Site
  • Northwood, United Kingdom, HA6 2RN
    • GSK Investigational Site
  • Orpington, United Kingdom, BR5 3QG
    • GSK Investigational Site
  • Shipley, United Kingdom, BD18 3SA
    • GSK Investigational Site
  • Wythenshawe, United Kingdom, M23 9LT
    • GSK Investigational Site
• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • GSK Investigational Site
    • Scottsdale, Arizona, United States, 85248
      • GSK Investigational Site
  • California
    • Encinitas, California, United States, 92024
      • GSK Investigational Site
    • Mission Viejo, California, United States, 92691
      • GSK Investigational Site
    • Paramount, California, United States, 90723
      • GSK Investigational Site
    • Roseville, California, United States, 95661
      • GSK Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • GSK Investigational Site
    • Colorado Springs, Colorado, United States, 80923
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • GSK Investigational Site
    • Gainesville, Florida, United States, 32608
      • GSK Investigational Site
    • Miami, Florida, United States, 33173
      • GSK Investigational Site
    • Miami, Florida, United States, 33186
      • GSK Investigational Site
    • Miami, Florida, United States, 33155
      • GSK Investigational Site
    • Miami, Florida, United States, 15801
      • GSK Investigational Site
    • Orlando, Florida, United States, 32713
      • GSK Investigational Site
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • GSK Investigational Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • GSK Investigational Site
    • Oak Lawn, Illinois, United States, 60453
      • GSK Investigational Site
  • Iowa
    • Ames, Iowa, United States, 50010
      • GSK Investigational Site
    • Iowa City, Iowa, United States, 52242
      • GSK Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • GSK Investigational Site
    • Topeka, Kansas, United States, 66606
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67214
      • GSK Investigational Site
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • GSK Investigational Site
    • Shreveport, Louisiana, United States, 71115
      • GSK Investigational Site
  • Maryland
    • Annapolis, Maryland, United States, 21404
      • GSK Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • GSK Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • GSK Investigational Site
    • Ypsilanti, Michigan, United States, 48197
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63110
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63141
      • GSK Investigational Site
  • Montana
    • Missoula, Montana, United States, 59808
      • GSK Investigational Site
  • New Jersey
    • Jersey City, New Jersey, United States, 07304
      • GSK Investigational Site
  • New York
    • Bronx, New York, United States, 10461
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 28401
      • GSK Investigational Site
    • Rocky Mount, North Carolina, United States, 27804
      • GSK Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43215
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45417
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
    • Tulsa, Oklahoma, United States, 74136
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
    • Portland, Oregon, United States, 97202
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • GSK Investigational Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • GSK Investigational Site
    • Little River, South Carolina, United States, 29566
      • GSK Investigational Site
    • Mount Pleasant, South Carolina, United States, 29464
      • GSK Investigational Site
    • Rock Hill, South Carolina, United States, 29732
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
    • Knoxville, Tennessee, United States, 37938
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75231-4307
      • GSK Investigational Site
    • Houston, Texas, United States, 77074
      • GSK Investigational Site
    • Houston, Texas, United States, 77401
      • GSK Investigational Site
    • McKinney, Texas, United States, 75069
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • Waco, Texas, United States, 76712
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • GSK Investigational Site
    • Williamsburg, Virginia, United States, 23188
      • GSK Investigational Site
  • Washington
    • Bellevue, Washington, United States, 68123
      • GSK Investigational Site
    • Bellingham, Washington, United States, 98225
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLU-5937 25 mg; BLU-5937 oral dose 25 mg twice a day.	Drug: BLU-5937; Oral administration of BLU-5937 Tablets; Other Names: Camlipixant
Experimental: BLU-5937 50 mg; BLU-5937 oral dose 50 mg twice a day.	Drug: BLU-5937; Oral administration of BLU-5937 Tablets; Other Names: Camlipixant
Placebo Comparator: Placebo; Matching Placebo for BLU-5937 oral dose twice a day.	Drug: Placebo; Oral administration of matching placebo for BLU-5937 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12	The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.	Baseline, Week 12
Change from Baseline in Cough Severity Visual Analogue Scale at Week 12	Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity.	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	Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity.	Baseline, Week 12
Awake Cough Frequency at Week 12	Assessed using an ambulatory cough monitor	Week 12
Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 12	Assessed using an ambulatory cough monitor	Baseline, Week 12
Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12	The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.	Baseline, Week 12
Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 12	The CCD is a participant-completed daily diary used to assess chronic cough. The CCD score ranges from 0 to 16, with a higher score indicating worse symptoms.	Baseline, Week 12
Percentage of Participants with CCD Response at Week 12	Percentage of participants with CCD response will be summarized.	Week 12

Collaborators and Investigators

• Sponsor: Bellus Health Inc. - a GSK company
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): December 18, 2025
• Study Completion (Estimated): May 28, 2026

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Cough; Respiration Disorders; Chronic Cough; Signs and Symptoms, Respiratory
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Chronic Cough; Cough
• Other Study ID Numbers: 221850; BUS-P3-01 (Other Identifier: Bellus Health Inc); 2024-513460-26-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No