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

July 12, 2026 updated by: Bellus Health Inc. - a GSK company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
957

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1406AGA
        • GSK Investigational Site
      • Buenos Aires, Argentina, C199AAB
        • GSK Investigational Site
      • Ciudad Autonoma Buenos Aires, Argentina, C1128AAF
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1027AAP
        • GSK Investigational Site
      • Córdoba, 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 Tucumán, Argentina, T4000IAI
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
      • Vicente López, Argentina, 1602
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1200
        • GSK Investigational Site
      • Ghent, Belgium, 9000
        • GSK Investigational Site
      • Kortrijk, Belgium, 8500
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liège, 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
    • 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
      • Québec, Quebec, Canada, G1V 4G5
        • GSK Investigational Site
      • Québec, Quebec, Canada, G1N 4V3
        • GSK Investigational Site
      • Québec, Quebec, Canada, G1V 4W2
        • GSK Investigational Site
      • Québec, Quebec, Canada, G3K 2P8
        • GSK Investigational Site
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • GSK Investigational Site
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
      • Victoriaville, Quebec, Canada, G6P 6P6
        • GSK Investigational Site
  • Colombia
      • Floridablanca, Colombia, 681004
        • GSK Investigational Site
      • Medellín, Colombia, 050034
        • GSK Investigational Site
      • Medellín, Colombia, 00000
        • GSK Investigational Site
      • Medellín, Colombia, 50021
        • GSK Investigational Site
  • France
      • Dijon, France, 21079
        • GSK Investigational Site
      • Lille, France, 59037
        • GSK Investigational Site
      • Marseille, France, 13003
        • GSK Investigational Site
      • Marseille, France, 13015
        • GSK Investigational Site
      • Montpellier, France, 34295
        • GSK Investigational Site
      • Paris, France, 75014
        • GSK Investigational Site
      • Strasbourg, France, 67091
        • GSK Investigational Site
      • Toulouse, France, 31000
        • GSK Investigational Site
  • Hungary
      • Balatonfüred, Hungary, 8230
        • GSK Investigational Site
      • Budapest, Hungary, 1033
        • GSK Investigational Site
      • Budapest, Hungary, 1027
        • GSK Investigational Site
      • Gödöllő, Hungary, 2100
        • GSK Investigational Site
      • Hajdúnánás, Hungary, 4080
        • GSK Investigational Site
      • Mosonmagyaróvár, Hungary, 9300
        • GSK Investigational Site
      • Pécs, Hungary, 7635
        • GSK Investigational Site
      • Püspökladány, Hungary, 4150
        • GSK Investigational Site
  • India
      • Aurangabad, India, 431003
        • GSK Investigational Site
      • Bengaluru, India, 560068
        • GSK Investigational Site
      • Bikaner, India, 334001
        • 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
      • Petah 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 Świętokrzyski, Poland, 27-400
        • GSK Investigational Site
      • Piaseczno, Poland, 05-500
        • GSK Investigational Site
      • Rzeszów, Poland, 35-051
        • GSK Investigational Site
      • Tarnów, 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, 2001
        • 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
      • Málaga, Spain, 29010
        • GSK Investigational Site
      • Málaga, Spain, 29004
        • GSK Investigational Site
      • Pamplona, Spain, 31008
        • GSK Investigational Site
      • Pozuelo de Alarcón, Spain, 28223
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34020
        • GSK Investigational Site
      • Izmir, Turkey (Türkiye), 35100
        • GSK Investigational Site
      • Izmir, Turkey (Türkiye), 35110
        • GSK Investigational Site
      • Mersin, Turkey (Türkiye), 33343
        • 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
      • Wishaw, United Kingdom, ML2 0DP
        • GSK Investigational Site
      • Wythenshawe, United Kingdom, M23 9LT
        • GSK Investigational Site
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85248
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • 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
      • St Louis, Missouri, United States, 63110
        • GSK Investigational Site
      • St 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
      • The 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
      • Mt. 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-Hour Cough Frequency
Time Frame: Week 12
Assessed using an ambulatory cough monitor
Week 12
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 52
Time Frame: Baseline, 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
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52
Time Frame: Baseline, 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
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 52
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 52
Time Frame: Baseline, 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
Time Frame: Baseline, Week 52
Baseline, Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Week 12
Percentage of participants with CCD response will be summarized.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bellus Health Inc. - a GSK company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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