A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Launched by BELLUS HEALTH INC. - A GSK COMPANY · Oct 25, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called CALM-2, is studying a new treatment called BLU-5937 for adults who have refractory chronic cough (RCC). RCC is a persistent cough that lasts for more than a year and is not explained by other medical conditions. The trial aims to find out if BLU-5937 is effective and safe for people suffering from this condition. It is a Phase 3 study, meaning it's one of the final stages before the treatment can potentially be approved for general use. The study is currently recruiting participants aged 18 to 80, and both men and women are welcome to join.
To be eligible, participants need to have had a chronic cough for at least a year and must be able to give informed consent. Women who can become pregnant will need to use effective contraception during the study and for two weeks after the last dose. Certain individuals, such as current smokers or those with specific lung diseases, cannot participate. If chosen to join, participants will receive either the treatment or a placebo (a dummy pill) for 24 weeks, and they will be monitored to see how well the treatment works and if there are any side effects. This study can offer hope for those struggling with a bothersome cough that has not improved with other treatments.
Gender
ALL
Eligibility criteria
- 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
About Bellus Health Inc. A Gsk Company
Bellus Health Inc., a subsidiary of GSK, is a biopharmaceutical company dedicated to the development of innovative therapies for patients with chronic cough and other hypersensitivity-related conditions. Leveraging advanced scientific expertise and a robust pipeline, Bellus Health focuses on addressing unmet medical needs through cutting-edge research and clinical development. With a commitment to improving patient outcomes, the company integrates rigorous clinical trial methodologies and regulatory standards, ensuring the delivery of safe and effective therapeutic options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Adelaide, South Australia, Australia
Danville, Pennsylvania, United States
Cleveland, Ohio, United States
Saint Louis, Missouri, United States
Norfolk, Virginia, United States
London, , United Kingdom
Washington, District Of Columbia, United States
Adelaide, South Australia, Australia
Philadelphia, Pennsylvania, United States
San Diego, California, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Edina, Minnesota, United States
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Berlin, , Germany
Nagasaki, , Japan
Wheat Ridge, Colorado, United States
Omaha, Nebraska, United States
Philadelphia, Pennsylvania, United States
Nedlands, Western Australia, Australia
Denver, Colorado, United States
Saint Louis, Missouri, United States
Hamburg, , Germany
Paramount, California, United States
San Jose, California, United States
Rochester, Minnesota, United States
Hamilton, , New Zealand
New Lambton Heights, New South Wales, Australia
Dallas, Texas, United States
San Antonio, Texas, United States
Cottingham, East Riding Of Yorkshire, United Kingdom
Chelmsford, Essex, United Kingdom
Hull, , United Kingdom
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kaohsiung, , Taiwan
Seoul, , Korea, Republic Of
Chermside, Queensland, Australia
Jinan, , China
Belfast, , United Kingdom
Christchurch, , New Zealand
Dunedin, , New Zealand
Norcross, Georgia, United States
Chermside, Queensland, Australia
Beijing, , China
Shanghai, , China
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kosice, , Slovakia
Kaohsiung, , Taiwan
Aichi, , Japan
Seoul, , Korea, Republic Of
Edina, Minnesota, United States
Seoul, , Korea, Republic Of
Tochigi, , Japan
Kyoto, , Japan
Chiba, , Japan
River Forest, Illinois, United States
Spisska Nova Ves, , Slovakia
Frankfurt, , Germany
Coffs Harbour, New South Wales, Australia
Columbus, Ohio, United States
Fukui, , Japan
Osaka, , Japan
Brno, , Czechia
Dunedin, , New Zealand
Kagoshima, , Japan
Saint Louis, Missouri, United States
Seoul, , Korea, Republic Of
London, , United Kingdom
Cumming, Georgia, United States
Akita, , Japan
Hokkaido, , Japan
Ibaraki, , Japan
Kralupy Nad Vltavou, , Czechia
Charlotte, North Carolina, United States
Franklin, Tennessee, United States
Fukushima, , Japan
Belfast, , United Kingdom
Charleston, South Carolina, United States
Toyama, , Japan
North Shields, Tyne & Wear, United Kingdom
Seoul, , Korea, Republic Of
Kanagawa, , Japan
Hyogo, , Japan
Frisco, Texas, United States
Hefei, , China
Wuxi, , China
Nashik, , India
Tyne And Wear, , United Kingdom
Niigata, , Japan
San Diego, California, United States
Seoul, , Korea, Republic Of
Los Angeles, California, United States
San Jose, California, United States
Sweetwater, Florida, United States
Busan, , Korea, Republic Of
Rotorua, , New Zealand
Changhua, , Taiwan
Christchurch, , New Zealand
Mie, , Japan
Tokyo, , Japan
Kagawa, , Japan
Seoul, , Korea, Republic Of
Bardejov, , Slovakia
Nedlands, Western Australia, Australia
Gastonia, North Carolina, United States
Seongnam, Gyeonggi Do, Korea, Republic Of
Belgaum, Karnataka, India
Frankfurt, Hessen, Germany
Charlotte, North Carolina, United States
Shizuoka, , Japan
Kaohsiung, , Taiwan
Woodbury, Minnesota, United States
Peoria, Arizona, United States
Saitama, , Japan
Bardejov, , Slovakia
Taoyuan County, , Taiwan
Busan, , Korea, Republic Of
Wonju Si, , Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, Gangnam Gu, Korea, Republic Of
Omaha, Nebraska, United States
Redding, California, United States
Coffs Harbour, New South Wales, Australia
Miami Lakes, Florida, United States
Seoul, , Korea, Republic Of
Santa Rosa Beach, Florida, United States
Los Angeles, California, United States
Hull, , United Kingdom
Spearwood, Western Australia, Australia
Spearwood, Western Australia, Australia
Olomouc, , Czechia
Nagpur, Maharashtra, India
Yamaguchi, , Japan
Nanchang, , China
Zhengzhou, , China
Franklin, Tennessee, United States
Nelson, , New Zealand
Guangzhou, , China
Methuen, Massachusetts, United States
Brandýs Nad Labem, , Czechia
Wŏnju, Gangwon Do, Korea, Republic Of
Spišská Nová Ves, , Slovakia
Košice, , Slovakia
Prievidza, , Slovakia
Jeonju, Jeollabuk Do, Korea, Republic Of
Xiamen, , China
Colorado Springs, Colorado, United States
Cincinnati, Ohio, United States
Macquarie University, New South Wales, Australia
Winston Salem, North Carolina, United States
Belfast, , United Kingdom
Dongguan, , China
Leesburg, Florida, United States
Ankeny, Iowa, United States
Portsmouth, New Hampshire, United States
Cypress, Texas, United States
Brno, , Czechia
Gulf Shores, Alabama, United States
Norfolk, Virginia, United States
Coventry, West Midlands, United Kingdom
Strakonice, , Czechia
Chermside, Queensland, Australia
Heidelberg, Baden Wuerttemberg, Germany
Muenchen, Bayern, Germany
Darmstadt, Hessen, Germany
Frankfurt Am Main, Hessen, Germany
Frankfurt, Hessen, Germany
Marburg, Hessen, Germany
Neu Isenburg, Hessen, Germany
Halle, Sachsen Anhalt, Germany
Geesthacht, Schleswig Holstein, Germany
Großhansdorf, Schleswig Holstein, Germany
Luebeck, Schleswig Holstein, Germany
Berlin, , Germany
Berlin, , Germany
Auckland, , New Zealand
Christchurch, , New Zealand
Rotorua, , New Zealand
Chang Hua, , Taiwan
Taoyuan, , Taiwan
Kralupy Nad Vltavou, , Czechia
Miroslav, , Czechia
Prague, , Czechia
Strakonice, , Czechia
Denmark Hill, London, United Kingdom
Corby, Northamptonshire, United Kingdom
Nagpur, , India
Visakhapatnam, Andhra Pradesh, India
Faridabad, Haryana, India
Nashik, Maharashtra, India
Varanasi, Uttar Pradesh, India
Fukuoka, , Japan
Yinchuan, , China
Liuzhou, , China
Hiroshima, , Japan
Miyazaki, , Japan
Hannover, , Germany
Jeonju, , Korea, Republic Of
Corby, , United Kingdom
Heidelberg, , Germany
Meizhou, , China
Yangzhou, , China
Darmstadt, , Germany
Geesthacht, , Germany
Luebeck, , Germany
Muenchen, , Germany
Neu Isenburg, , Germany
Schleswig, , Germany
Shenyang, , China
Huhhot, , China
Dresden, , Germany
Karlsruhe, , Germany
Huizhou, , China
Wishaw, , United Kingdom
Guilin, , China
Shenzhen, , China
Zhanjiang, , China
Jiangsu, , China
Taizhou, , China
Wei Fang, , China
Ebdentown, , New Zealand
Santa Rosa Beach, Florida, United States
New Lambton Heights, New South Wales, Australia
Chengdu, , China
Chongqing, , China
Ganzhou, , China
Kunming, , China
Leshan, , China
Pingxiang, , China
Urumqi, , China
Brandys Nad Labem, , Czechia
Miroslav, , Czechia
Prague 4, , Czechia
Frankfurt Am Main, , Germany
Fuerstenwalde Spree, , Germany
Halle, , Germany
Marburg, , Germany
Faridabad, , India
Gurgaon, , India
Nashik, , India
Visakhapatnam, , India
Gifu, , Japan
Nankoku Shi, , Japan
Yokohama, , Japan
Auckland, , New Zealand
Hamilton, , New Zealand
Bardejov, , Slovakia
Humenne, , Slovakia
Kezmarok, , Slovakia
Prievidza, , Slovakia
Corby, , United Kingdom
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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