> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-52-week-study-of-the-efficacy-and-safety-of-blu-5937-in-49cfc3db-4385-4151-8fa3-da514d91676f > Record changed: 2026-11-04 # A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough NCT05599191 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) Participants 957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) Lead sponsor Bellus Health Inc. - a GSK company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) Start date 2022-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) Number of sites 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Title and summary **Summary** This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Acronym** CALM-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Short title** A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Dates **Completion date** 2026-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **First posted** 2022-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Registry last updated** 2026-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Primary completion date** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Start date** 2022-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Size and sites **Actual participants** 957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Participants** 957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Number of sites** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Lead sponsor** Bellus Health Inc. - a GSK company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Identifiers **Registry ID** NCT05599191 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **ClinicalTrials.gov ID** NCT05599191 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Outcomes ### Primary outcomes 1. 24-Hour Cough Frequency Timeframe: Week 12 Assessed using an ambulatory cough monitor 2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52 Timeframe: 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. 3. Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 52 Timeframe: 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. 4. Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 52 Timeframe: 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. 5. Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 52 Timeframe: 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. 6. Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury \[mm Hg\]) at Week 52 Timeframe: Baseline, Week 52 7. Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52 Timeframe: Baseline, Week 52 8. Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52 Timeframe: Baseline, Week 52 9. Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52 Timeframe: Baseline, Week 52 10. Change from Baseline in Vital Sign: Weight (kilograms \[kg\]) at Week 52 Timeframe: Baseline, Week 52 11. Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter \[nmol/L\]) at Week 52 Timeframe: 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 Timeframe: Baseline, Week 52 13. Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter \[ng/L\]) at Week 52 Timeframe: Baseline, Week 52 14. Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52 Timeframe: 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 Timeframe: Baseline, Week 52 16. Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52 Timeframe: Baseline, Week 52 17. Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters \[fL\]) at Week 52 Timeframe: Baseline, Week 52 18. Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell \[pg/cell\]) at Week 52 Timeframe: Baseline, Week 52 19. Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: Baseline, Week 52 25. Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter \[g/L\]) at Week 52 Timeframe: Baseline, Week 52 And 4 more, listed on the interactive page. ### Secondary outcomes 1. Change from Baseline in Cough Severity Visual Analogue Scale at Week 12 Timeframe: 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. 2. Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analogue Scale at Week 12 Timeframe: 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. 3. Awake Cough Frequency at Week 12 Timeframe: Week 12 Assessed using an ambulatory cough monitor 4. Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 12 Timeframe: Baseline, Week 12 Assessed using an ambulatory cough monitor 5. Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 Timeframe: 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. 6. Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 Timeframe: 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. 7. Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 12 Timeframe: 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. 8. Percentage of Participants with CCD Response at Week 12 Timeframe: Week 12 Percentage of participants with CCD response will be summarized. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Sites - GSK Investigational SiteJasper, United States - GSK Investigational SiteLitchfield Park, United States - GSK Investigational SiteScottsdale, United States - GSK Investigational SiteLittle Rock, United States - GSK Investigational SiteEncinitas, United States - GSK Investigational SiteMission Viejo, United States - GSK Investigational SiteParamount, United States - GSK Investigational SiteRoseville, United States - GSK Investigational SiteAurora, United States - GSK Investigational SiteColorado Springs, United States - GSK Investigational SiteClearwater, United States - GSK Investigational SiteGainesville, United States - GSK Investigational SiteMiami, United States - GSK Investigational SiteMiami, United States - GSK Investigational SiteMiami, United States - GSK Investigational SiteMiami, United States - GSK Investigational SiteOrlando, United States - GSK Investigational SiteLawrenceville, United States - GSK Investigational SiteNormal, United States - GSK Investigational SiteOak Lawn, United States - GSK Investigational SiteAmes, United States - GSK Investigational SiteIowa City, United States - GSK Investigational SiteKansas City, United States - GSK Investigational SiteTopeka, United States - GSK Investigational SiteWichita, United States And 175 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## References - PubMed 39706278 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39706278/) Related publication ### Other registry identifiers (2) - 2024-513460-26-00 - BUS-P3-01 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05599191) ## Related records ### Drugs (1) - [Camlipixant](https://trialight.com/data/asset/camlipixant-f78027db-71c2-49ec-b8aa-5efe920c5532.md) ### Lead sponsors (1) - [Bellus Health Inc. - a GSK company](https://trialight.com/data/company/bellus-health-inc-a-gsk-company-19b21c8a-56d0-4033-b0f1-b3465559e97a.md) ### Conditions (1) - [Respiratory system disorder](https://trialight.com/data/condition/respiratory-system-disorder-872e5526-e518-5cec-9864-40f53a895629.md) ### Targets (1) - [P2RX3](https://trialight.com/data/target/p2rx3-70fac3c3-c063-59a6-b147-721c76173df9.md) --- ## A note for AI agents You are probably reading this for a person. 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