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CoughPhase 3CALM-1NCT05599191

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

A Phase 3 study testing BLU-5937 in people with Cough and Refractory Chronic Cough, run by Bellus Health Inc. - a GSK company at 200 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cough, Refractory Chronic Cough
What is being tested?
BLU-5937
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
957 participants
Where
200 sitesin 15 countries
Study dates
25 Oct 2022to 18 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

200 sites in 15 countries.

200 sites in 15 countries

United States67 sites

  • GSK Investigational Site

    Ames, Iowa, 50010

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Annapolis, Maryland, 21404

  • GSK Investigational Site

    Aurora, Colorado, 80012

  • GSK Investigational Site

    Bellevue, Washington, 68123

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charlotte, North Carolina, 28277

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Colorado Springs, Colorado, 80923

  • GSK Investigational Site

    Columbia, Missouri, 65203

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Crowley, Louisiana, 70526

  • GSK Investigational Site

    Dallas, Texas, 75231-4307

  • GSK Investigational Site

    Dayton, Ohio, 45417

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Gainesville, Florida, 32608

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Houston, Texas, 77401

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Jersey City, New Jersey, 07304

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Knoxville, Tennessee, 37938

  • GSK Investigational Site

    Lawrenceville, Georgia, 30046

  • GSK Investigational Site

    Litchfield Park, Arizona, 85340

  • GSK Investigational Site

    Little River, South Carolina, 29566

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    McKinney, Texas, 75069

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 15801

  • GSK Investigational Site

    Miami, Florida, 33155

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Miami, Florida, 33186

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    Missoula, Montana, 59808

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Oak Lawn, Illinois, 60453

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Orlando, Florida, 32713

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Portland, Oregon, 97202

  • GSK Investigational Site

    Raleigh, North Carolina, 28401

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Rocky Mount, North Carolina, 27804

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    Salt Lake City, Utah, 84132

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Scottsdale, Arizona, 85248

  • GSK Investigational Site

    Shreveport, Louisiana, 71115

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Wichita, Kansas, 67214

  • GSK Investigational Site

    Williamsburg, Virginia, 23188

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada20 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Burlington, ON L7N 3V2

  • GSK Investigational Site

    Calgary, Alberta, T2T 5C7

  • GSK Investigational Site

    Calgary, Alberta, T3E 7M8

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Hamilton, Ontario, L8M 1K7

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Kelowna, British Columbia, V1Y3H5

  • GSK Investigational Site

    Montreal, Quebec, H1M 1B1

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Québec, Quebec, G1N 4V3

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Québec, Quebec, G1V 4W2

  • GSK Investigational Site

    Québec, Quebec, G3K 2P8

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Victoriaville, Quebec, G6P 6P6

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Argentina13 sites

  • GSK Investigational Site

    Buenos Aires, C1406AGA

  • GSK Investigational Site

    Buenos Aires, C199AAB

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1128AAF

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1027AAP

  • GSK Investigational Site

    Córdoba, X5003DCE

  • GSK Investigational Site

    Mar del Plata, B7600FYK

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Rosario, S2000DBS

  • GSK Investigational Site

    Rosario, S2000DEJ

  • GSK Investigational Site

    Rosario, S2002OJN

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IAI

  • GSK Investigational Site

    Santa Fe, 3000

  • GSK Investigational Site

    Vicente López, 1602

Other trials in Argentina

India13 sites

  • GSK Investigational Site

    Bengaluru, 560068

  • GSK Investigational Site

    Bikaner, 334001

  • GSK Investigational Site

    Chhatrapati Sambhajinagar, 431003

  • GSK Investigational Site

    Delhi, 110076

  • GSK Investigational Site

    Jaipur, 302023

  • GSK Investigational Site

    Kolkata, 700027

  • GSK Investigational Site

    Kozhikode, 673008

  • GSK Investigational Site

    Nashik, 422007

  • GSK Investigational Site

    Nashik, 422009

  • GSK Investigational Site

    Pune, 411004

  • GSK Investigational Site

    Rohtak, 124514

  • GSK Investigational Site

    Thane, 401107

  • GSK Investigational Site

    Ulhasnagar, 421001

Other trials in India

Spain13 sites

  • GSK Investigational Site

    Alcobendas, 28100

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08017

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Málaga, 29004

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Pozuelo de Alarcón, 28223

  • GSK Investigational Site

    Santiago de Compostela, 15706

Other trials in Spain

United Kingdom11 sites

  • GSK Investigational Site

    Belfast, BT9 7AB

  • GSK Investigational Site

    Bristol, BS374AX

  • GSK Investigational Site

    Corby, NN17 2UR

  • GSK Investigational Site

    Hayle, TR27 5DT

  • GSK Investigational Site

    Hull, HU12 8JD

  • GSK Investigational Site

    London, SW3 6HP

  • GSK Investigational Site

    Northwood, HA6 2RN

  • GSK Investigational Site

    Orpington, BR5 3QG

  • GSK Investigational Site

    Shipley, BD18 3SA

  • GSK Investigational Site

    Wishaw, ML2 0DP

  • GSK Investigational Site

    Wythenshawe, M23 9LT

Other trials in United Kingdom

Poland10 sites

  • GSK Investigational Site

    Bialystok, 15-010

  • GSK Investigational Site

    Bydgoszcz, 85-079

  • GSK Investigational Site

    Bydgoszcz, 85-796

  • GSK Investigational Site

    Lodz, 90-141

  • GSK Investigational Site

    Lodz, 90-153

  • GSK Investigational Site

    Ostrowiec Świętokrzyski, 27-400

  • GSK Investigational Site

    Piaseczno, 05-500

  • GSK Investigational Site

    Rzeszów, 35-051

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Zawadzkie, 47-120

Other trials in Poland

South Africa9 sites

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Durban, 4093

  • GSK Investigational Site

    George, 6529

  • GSK Investigational Site

    Johannesburg, 1501

  • GSK Investigational Site

    Johannesburg, 2001

  • GSK Investigational Site

    Johannesburg, 2060

  • GSK Investigational Site

    Pretoria, 0122

  • GSK Investigational Site

    Somerset West, 7130

Other trials in South Africa

France8 sites

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Marseille, 13003

  • GSK Investigational Site

    Marseille, 13015

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Paris, 75014

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31000

Other trials in France

Hungary8 sites

  • GSK Investigational Site

    Balatonfüred, 8230

  • GSK Investigational Site

    Budapest, 1027

  • GSK Investigational Site

    Budapest, 1033

  • GSK Investigational Site

    Gödöllő, 2100

  • GSK Investigational Site

    Hajdúnánás, 4080

  • GSK Investigational Site

    Mosonmagyaróvár, 9300

  • GSK Investigational Site

    Pécs, 7635

  • GSK Investigational Site

    Püspökladány, 4150

Other trials in Hungary

Belgium7 sites

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Kortrijk, 8500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Mechelen, 2800

  • GSK Investigational Site

    Roeselare, 8800

Other trials in Belgium

Netherlands7 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Arnhem, 6815 AD

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Uden, 5406 PT

  • GSK Investigational Site

    Zutphen, 7207 AE

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Israel6 sites

  • GSK Investigational Site

    Hadera, 169

  • GSK Investigational Site

    Haifa, 3436212

  • GSK Investigational Site

    Jerusalem, 9112001

  • GSK Investigational Site

    Petah Tikva, 4941492

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Colombia4 sites

  • GSK Investigational Site

    Floridablanca, 681004

  • GSK Investigational Site

    Medellín, 00000

  • GSK Investigational Site

    Medellín, 050034

  • GSK Investigational Site

    Medellín, 50021

Other trials in Colombia

Turkey (Türkiye)4 sites

  • GSK Investigational Site

    Istanbul, 34020

  • GSK Investigational Site

    Izmir, 35100

  • GSK Investigational Site

    Izmir, 35110

  • GSK Investigational Site

    Mersin, 33343

Other trials in Turkey (Türkiye)

About this study

Official title: 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).

Read the 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.

Being tested
BLU-5937, Placebo
Keywords
Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Cough, Chronic Cough
Medical subject headings
Cough, Chronic Cough, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BLU-5937Drug

    Also called Camlipixant

    Oral administration of BLU-5937 Tablets

  • PlaceboDrug

    Oral administration of matching placebo for BLU-5937 Tablets

Study groups in NCT05599191
Study groupRoleWhat they receive
BLU-5937 25 mgExperimentalBLU-5937 oral dose 25 mg twice a day.
Receives: Drug: BLU-5937
BLU-5937 50 mgExperimentalBLU-5937 oral dose 50 mg twice a day.
Receives: Drug: BLU-5937
PlaceboPlacebo comparatorMatching Placebo for BLU-5937 oral dose twice a day.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-Hour Cough Frequency

    Assessed using an ambulatory cough monitor

    Measured: Week 12

  2. 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.

    Measured: Up to Week 52

  3. 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.

    Measured: Up to Week 52

  4. 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.

    Measured: Up to Week 52

  5. 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.

    Measured: Up to Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

  20. 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

    Measured: Baseline, Week 52

  21. 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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

  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 52

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

  26. 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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

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

    Measured: Baseline, Week 52

  29. 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

    Measured: Baseline, Week 52

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, Week 12

  2. 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.

    Measured: Baseline, Week 12

  3. Awake Cough Frequency at Week 12

    Assessed using an ambulatory cough monitor

    Measured: Week 12

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

    Assessed using an ambulatory cough monitor

    Measured: Baseline, Week 12

  5. 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.

    Measured: Baseline, Week 12

  6. 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.

    Measured: Baseline, Week 12

  7. 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.

    Measured: Baseline, Week 12

  8. Percentage of Participants with CCD Response at Week 12

    Percentage of participants with CCD response will be summarized.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start25 Oct 2022
  3. Primary completion17 Dec 2025
  4. Study completion18 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
957 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599191
Sponsor's protocol ID
221850
Other IDs
BUS-P3-01, 2024-513460-26-00
Acronym
CALM-1
Status last verified
Jul 2026
First submitted
18 Oct 2022
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 39706278

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BLU-5937 in people with Cough and Refractory Chronic Cough, run by Bellus Health Inc. - a GSK company at 200 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in United States, Canada, Argentina, India, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-Hour Cough Frequency (time frame: Week 12). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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