Last updated: 11/24/2025 05:20:22
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic CoughCALM-2
GSK study ID
221851
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
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)
Trial description: This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
24-Hour Cough Frequency
Timeframe: Week 24
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24
Timeframe: Up to Week 24
Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24
Timeframe: Up to Week 24
Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24
Timeframe: Up to Week 24
Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24
Timeframe: Up to Week 24
Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Male Reproductive Hormones: Follicle-Stimulating Hormone [FSH] and Luteinizing Hormone [LH] (international units per liter [IU/L]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 24
Timeframe: Baseline, Week 24
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
Timeframe: Baseline, Week 24
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
Timeframe: Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase (ALP) and Creatine Kinase (CK) (international units per liter [IU/L]) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 24
Timeframe: Baseline, Week 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
Timeframe: Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 24
Timeframe: Baseline, Week 24
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
Timeframe: Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 24
Timeframe: Baseline, Week 24
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
Timeframe: Baseline, Week 24
Secondary outcomes:
Change from Baseline in Cough Severity Visual Analogue Scale at Week 24
Timeframe: Baseline, Week 24
Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analog Scale at Week 24
Timeframe: Baseline, Week 24
Awake Cough Frequency at Week 24
Timeframe: Week 24
Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24
Timeframe: Baseline, Week 24
Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24
Timeframe: Baseline, Week 24
Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 24
Timeframe: Baseline, Week 24
Percentage of Participants with CCD Response at Week 24
Timeframe: Week 24
Interventions:
Enrollment:
975
Primary completion date:
2026-17-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cough, Refractory Chronic Cough
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2022 to March 2027
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
No
- Capable of giving signed informed consent
- Refractory chronic cough (including unexplained chronic cough) for at least one year
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Kralupy nad Vltavou, Czech Republic, 278 01
Status
Recruiting
Location
GSK Investigational Site
Macquarie University, NSW, Australia, 2109
Status
Recruiting
Location
GSK Investigational Site
Fuerstenwalde Spree, Germany, 15517
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frisco, TX, United States, 75034
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santa Rosa Beach, FL, United States, 32459
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, CO, United States, 80923
Status
Recruiting
Location
GSK Investigational Site
Cypress, TX, United States, 77429
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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