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CoughPhase 3CALM-2NCT05600777

A 24-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 242 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

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
997 participants
Where
242 sitesin 13 countries
Study dates
5 Dec 2022to 17 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

242 sites in 13 countries.

242 sites in 13 countries

United States57 sites

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Aurora, Colorado, 80012

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charleston, South Carolina, 29412

  • GSK Investigational Site

    Charlotte, North Carolina, 28211

  • GSK Investigational Site

    Chevy Chase, Maryland, 20815

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Colorado Springs, Colorado, 80923

  • GSK Investigational Site

    Columbus, Ohio, 43235

  • GSK Investigational Site

    Cumming, Georgia, 30041

  • GSK Investigational Site

    Dallas, Texas, 75231-4307

  • GSK Investigational Site

    Danville, Pennsylvania, 17822

  • GSK Investigational Site

    Daytona Beach, Florida, 32117

  • GSK Investigational Site

    Denver, Colorado, 80230

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    Foley, Alabama, 36535

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33324

  • GSK Investigational Site

    Franklin, Tennessee, 37067

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Jacksonville, Florida, 32224

  • GSK Investigational Site

    Leesburg, Florida, 34748

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Litchfield Park, Arizona, 85340

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Methuen, Massachusetts, 01844

  • GSK Investigational Site

    Missoula, Montana, 59808

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Omaha, Nebraska, 68124

  • GSK Investigational Site

    Orlando, Florida, 32713

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    River Forest, Illinois, 60305

  • GSK Investigational Site

    Round Rock, Texas, 78681

  • GSK Investigational Site

    Sacramento, California, 95661

  • GSK Investigational Site

    San Antonio, Texas, 78207

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Diego, California, 92108

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Jose, California, 95117

  • GSK Investigational Site

    Santa Rosa Beach, Florida, 32459

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    St Louis, Missouri, 55905

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Sweetwater, Florida, 33172

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    West Des Moines, Iowa, 50266

  • GSK Investigational Site

    Wheat Ridge, Colorado, 96001

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Woodbury, Minnesota, 55125

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan48 sites

  • GSK Investigational Site

    Aichi, 460-0001

  • GSK Investigational Site

    Aichi, 467-8602

  • GSK Investigational Site

    Akita, 010-8543

  • GSK Investigational Site

    Chiba, 260-8677

  • GSK Investigational Site

    Fukui, 910-1193

  • GSK Investigational Site

    Fukuoka, 807-8556

  • GSK Investigational Site

    Fukuoka, 812-8582

  • GSK Investigational Site

    Fukuoka, 819-8555

  • GSK Investigational Site

    Fukushima, 960-1295

  • GSK Investigational Site

    Gifu, 153-8515

  • GSK Investigational Site

    Gifu, 501-6062

  • GSK Investigational Site

    Gifu, 509-6134

  • GSK Investigational Site

    Hiroshima, 730-0853

  • GSK Investigational Site

    Hiroshima, 735-8585

  • GSK Investigational Site

    Hokkaido, 064-0804

  • GSK Investigational Site

    Hyōgo, 663-8501

  • GSK Investigational Site

    Hyōgo, 670-8520

  • GSK Investigational Site

    Hyōgo, 672-8064

  • GSK Investigational Site

    Hyōgo, 674-0063

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Kagoshima, 890-8520

  • GSK Investigational Site

    Kanagawa, 231-8682

  • GSK Investigational Site

    Kanagawa, 232-0024

  • GSK Investigational Site

    Kanagawa, 234-8503

  • GSK Investigational Site

    Kyoto, 606-8507

  • GSK Investigational Site

    Kyoto, 612-8555

  • GSK Investigational Site

    Mie, 515-8544

  • GSK Investigational Site

    Miyazaki, 889-4304

  • GSK Investigational Site

    Nagasaki, 852-8501

  • GSK Investigational Site

    Nankoku-shi, 783-8509

  • GSK Investigational Site

    Niigata, 950-1197

  • GSK Investigational Site

    Osaka, 545-8586

  • GSK Investigational Site

    Osaka, 577-0843

  • GSK Investigational Site

    Osaka, 589-8511

  • GSK Investigational Site

    Osaka, 591-8555

  • GSK Investigational Site

    Saitama, 350-0495

  • GSK Investigational Site

    Shizuoka, 420-8527

  • GSK Investigational Site

    Shizuoka, 426-8677

  • GSK Investigational Site

    Shizuoka, 432-8002

  • GSK Investigational Site

    Shizuoka, 433-8558

  • GSK Investigational Site

    Tochigi, 321-0293

  • GSK Investigational Site

    Tokyo, 104-0031

  • GSK Investigational Site

    Tokyo, 140-8522

  • GSK Investigational Site

    Tokyo, 150-8935

  • GSK Investigational Site

    Tokyo, 173-8606

  • GSK Investigational Site

    Tokyo, 204-8522

  • GSK Investigational Site

    Toyama, 930-8550

  • GSK Investigational Site

    Yokohama, 236-0004

Other trials in Japan

China41 sites

  • GSK Investigational Site

    Beijing, 100730

  • GSK Investigational Site

    Changsha, 410008

  • GSK Investigational Site

    Chengdu, 610021

  • GSK Investigational Site

    Chengdu, 610041

  • GSK Investigational Site

    Chongqing, 408099

  • GSK Investigational Site

    Dongguan, 523326

  • GSK Investigational Site

    Ganzhou, 341000

  • GSK Investigational Site

    Guangzhou, 510000

  • GSK Investigational Site

    Guangzhou, 510260

  • GSK Investigational Site

    Guilin, 541002

  • GSK Investigational Site

    Hangzhou, 310003

  • GSK Investigational Site

    Hefei, 230001

  • GSK Investigational Site

    Hefei, 230022

  • GSK Investigational Site

    Hohhot, 010017

  • GSK Investigational Site

    Huizhou, 516000

  • GSK Investigational Site

    Huizhou, 516001

  • GSK Investigational Site

    Jiangsu, 221004

  • GSK Investigational Site

    Jinan, 250021

  • GSK Investigational Site

    Jingzhou, 434020

  • GSK Investigational Site

    Kunming, 650032

  • GSK Investigational Site

    Kunshan, Jiangsu

  • GSK Investigational Site

    Leshan, Sichuan, 614003

  • GSK Investigational Site

    Liuzhou

  • GSK Investigational Site

    Meizhou, 514700

  • GSK Investigational Site

    Nanchang, 330038

  • GSK Investigational Site

    Pingxiang, 337055

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanghai, 200065

  • GSK Investigational Site

    Shanghai, 200080

  • GSK Investigational Site

    Shenyang, 110004

  • GSK Investigational Site

    Shenzhen, 518053

  • GSK Investigational Site

    Taizhou, 317000

  • GSK Investigational Site

    Ürümqi, Xinjiang, 830001

  • GSK Investigational Site

    Weifang

  • GSK Investigational Site

    Wenzhou, 325000

  • GSK Investigational Site

    Wuxi, 214023

  • GSK Investigational Site

    Xiamen, 361004

  • GSK Investigational Site

    Yangzhou, 225001

  • GSK Investigational Site

    Yinchuan

  • GSK Investigational Site

    Zhanjiang, 524045

  • GSK Investigational Site

    Zhengzhou, 450052

Other trials in China

Germany24 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10969

  • GSK Investigational Site

    Bochum, 44787

  • GSK Investigational Site

    Darmstadt, 64283

  • GSK Investigational Site

    Dresden, 01069

  • GSK Investigational Site

    Essen, 45355

  • GSK Investigational Site

    Frankfurt, 60590

  • GSK Investigational Site

    Frankfurt, 60596

  • GSK Investigational Site

    Frankfurt am Main, 60315

  • GSK Investigational Site

    Geesthacht, 21502

  • GSK Investigational Site

    Halle, 6108

  • GSK Investigational Site

    Hamburg, 20253

  • GSK Investigational Site

    Hanover, 30159

  • GSK Investigational Site

    Hanover, 30173

  • GSK Investigational Site

    Heidelberg, 69126

  • GSK Investigational Site

    Karlsruhe, 76137

  • GSK Investigational Site

    Lübeck, 23552

  • GSK Investigational Site

    Marburg, 35037

  • GSK Investigational Site

    München, 81241

  • GSK Investigational Site

    Neu-Isenburg, 63263

  • GSK Investigational Site

    Peine, 31224

  • GSK Investigational Site

    Schleswig, 24837

  • GSK Investigational Site

    Wallerfing, 94574

  • GSK Investigational Site

    Wiesbaden, 65205

Other trials in Germany

United Kingdom17 sites

  • GSK Investigational Site

    Belfast, BT7 2EB

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Bristol, BS374AX

  • GSK Investigational Site

    Chelmsford, CM1 7ET

  • GSK Investigational Site

    Corby, NN17 2UR

  • GSK Investigational Site

    Corby, NN18 9EZ

  • GSK Investigational Site

    Coventry, CV3 4FJ

  • GSK Investigational Site

    Hayle, TR27 5DT

  • GSK Investigational Site

    Hull, HU16 5JQ

  • GSK Investigational Site

    London, SE5 9RS

  • GSK Investigational Site

    Northwood, HA6 2RN

  • GSK Investigational Site

    Orpington, BR5 3QG

  • GSK Investigational Site

    Peterborough, PE3 9GZ

  • GSK Investigational Site

    Preston, PR2 9HT

  • GSK Investigational Site

    Shipley, BD18 3SA

  • GSK Investigational Site

    Tyne and Wear, NE29 8NH

  • GSK Investigational Site

    Wishaw, ML2 0DP

Other trials in United Kingdom

South Korea14 sites

  • GSK Investigational Site

    Busan, 49241

  • GSK Investigational Site

    Incheon, 21431

  • GSK Investigational Site

    Jeonju, 54907

  • GSK Investigational Site

    Seongnam, 13620

  • GSK Investigational Site

    Seoul, 03080

  • GSK Investigational Site

    Seoul, 03312

  • GSK Investigational Site

    Seoul, 03722

  • GSK Investigational Site

    Seoul, 06591

  • GSK Investigational Site

    Seoul, 08308

  • GSK Investigational Site

    Seoul, 133-792

  • GSK Investigational Site

    Seoul, 5030

  • GSK Investigational Site

    Seoul, 5505

  • GSK Investigational Site

    Seoul, 6351

  • GSK Investigational Site

    Wŏnju, 26426

Other trials in South Korea

Canada13 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Burlington, ON L7N 3V2

  • GSK Investigational Site

    Calgary, Alberta, T2N 1N4

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G4

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Montreal, Quebec, H1Y3H5

  • GSK Investigational Site

    Québec, Quebec, G1V 4T3

  • GSK Investigational Site

    Québec, Quebec, G1V 4W2

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Victoriaville, Quebec, G6P 3Z8

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Australia9 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Chermside, Queensland, 4032

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Macquarie University, New South Wales, 2109

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    New Lambton Heights, New South Wales, 2305

  • GSK Investigational Site

    Spearwood, Western Australia, 6163

  • GSK Investigational Site

    St Albans, Victoria, 3021

  • GSK Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

New Zealand7 sites

  • GSK Investigational Site

    Christchurch, 8011

  • GSK Investigational Site

    Ebdentown, Upper Hutt, 5018

  • GSK Investigational Site

    Havelock North, Hawke's Bay Region, 3410

  • GSK Investigational Site

    Kapiti, 5036

  • GSK Investigational Site

    Nelson, 7011

  • GSK Investigational Site

    Rotorua, 3010

  • GSK Investigational Site

    Tauranga, 3110

Other trials in New Zealand

India5 sites

  • GSK Investigational Site

    Belagavi, 590010

  • GSK Investigational Site

    Faridabad, 121006

  • GSK Investigational Site

    Nagpur, 44009

  • GSK Investigational Site

    Nashik, 422001

  • GSK Investigational Site

    Visakhapatnam, 530017

Other trials in India

Taiwan4 sites

  • GSK Investigational Site

    Changhua, 50006

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Kaohsiung City, 82445

  • GSK Investigational Site

    Taoyuan County, 333

Other trials in Taiwan

Czechia2 sites

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Strakonice, 38601

Other trials in Czechia

Slovakia1 site

  • GSK Investigational Site

    Bardejov, 8501

Other trials in Slovakia

About this study

Official title: A Phase 3, 24-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-2)

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 24 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 NCT05600777
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 24

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

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

    Measured: Up to Week 24

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

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

    Measured: Up to Week 24

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

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

    Measured: Up to Week 24

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

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

    Measured: Up to Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

  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 24

    Measured: Baseline, Week 24

  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 24

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

  24. Change from Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Calcium, Magnesium, Bicarbonate, Glucose, and Blood Urea Nitrogen (BUN) (millimoles per liter [mmol/L]) at Week 24

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

  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 24

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

  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 24

    Measured: Baseline, Week 24

Secondary outcomes (8)

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

    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 24

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

    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 24

  3. Awake Cough Frequency at Week 24

    Assessed using an ambulatory cough monitor

    Measured: Week 24

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

    Assessed using an ambulatory cough monitor

    Measured: Baseline, Week 24

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

    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 24

  6. Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24

    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 24

  7. Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 24

    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 24

  8. Percentage of Participants with CCD Response at Week 24

    Percentage of participants with CCD response will be summarized.

    Measured: Week 24

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 start5 Dec 2022
  3. Primary completion10 Jun 2026
  4. Study completion17 Mar 2027 (estimated)

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
997 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05600777
Sponsor's protocol ID
221851
Other IDs
BUS-P3-02, 2024-513462-19-00
Acronym
CALM-2
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

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 242 sites in 13 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: under way, not looking for participants, 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 242 sites in United States, Japan, China, Germany, United Kingdom and 8 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?

This study is still under way. Results are not available in the source record yet.

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 24). 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 NCT05600777.

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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