Last updated: 11/24/2025 06:01:01
A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic CoughCALM-1
GSK study ID
221850
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Active, not recruiting
Active, not recruiting
Trial overview
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)
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 12
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52
Timeframe: Up to Week 52
Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 52
Timeframe: Up to Week 52
Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 52
Timeframe: Up to Week 52
Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 52
Timeframe: Up to Week 52
Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 52
Timeframe: Baseline, Week 52
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
Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52
Timeframe: Baseline, Week 52
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
Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52
Timeframe: Baseline, Week 52
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
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
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
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
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
Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 52
Timeframe: Baseline, Week 52
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
Timeframe: Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 52
Timeframe: Baseline, Week 52
Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 52
Timeframe: Baseline, Week 52
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
Timeframe: Baseline, Week 52
Secondary outcomes:
Change from Baseline in Cough Severity Visual Analogue Scale at Week 12
Timeframe: Baseline, Week 12
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
Awake Cough Frequency at Week 12
Timeframe: Week 12
Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 12
Timeframe: Baseline, Week 12
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Timeframe: Baseline, Week 12
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
Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 12
Timeframe: Baseline, Week 12
Percentage of Participants with CCD Response at Week 12
Timeframe: Week 12
Interventions:
Drug: BLU-5937
Drug: Placebo
Enrollment:
825
Observational study model:
Not applicable
Primary completion date:
2025-18-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cough, Refractory Chronic Cough
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2022 to June 2026
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
Aurora, CO, United States, 80012
Status
Recruitment Complete
Location
GSK Investigational Site
Johannesburg, South Africa, 1501
Status
Recruitment Complete
Location
GSK Investigational Site
Colorado Springs, CO, United States, 80923
Status
Recruitment Complete
Location
GSK Investigational Site
Ostrowiec Swietokrzyski, Poland, 27-400
Status
Recruitment Complete
Location
GSK Investigational Site
Roseville, CA, United States, 95661
Status
Recruitment Complete
Location
GSK Investigational Site
San Antonio, TX, United States, 78229
Status
Recruitment Complete
Location
GSK Investigational Site
Ann Arbor, MI, United States, 48109
Status
Recruitment Complete
Location
GSK Investigational Site
Annapolis, MD, United States, 21404
Status
Recruitment Complete
Location
GSK Investigational Site
Dallas, TX, United States, 75231-4307
Status
Recruitment Complete
Location
GSK Investigational Site
Mission Viejo, CA, United States, 92691
Status
Recruitment Complete
Location
GSK Investigational Site
Salisbury, NC, United States, 28144
Status
Recruitment Complete
Location
GSK Investigational Site
Greenfield Park, QC, Canada, J4V 2H1
Status
Recruitment Complete
Location
GSK Investigational Site
Victoriaville, QC, Canada, G6P 6P6
Status
Recruitment Complete
Location
GSK Investigational Site
Ypsilanti, MI, United States, 48197
Status
Recruitment Complete
Location
GSK Investigational Site
Clearwater, FL, United States, 33756
Status
Recruitment Complete
Location
GSK Investigational Site
Encinitas, CA, United States, 92024
Status
Recruitment Complete
Location
GSK Investigational Site
Jasper, AL, United States, 35501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Medford, OR, United States, 97504
Status
Recruitment Complete
Location
GSK Investigational Site
Missoula, MT, United States, 59808
Status
Recruitment Complete
Location
GSK Investigational Site
Topeka, KS, United States, 66606
Status
Recruitment Complete
Location
GSK Investigational Site
Belfast, United Kingdom, BT9 7AB
Status
Recruitment Complete
Location
GSK Investigational Site
Bellingham, WA, United States, 98225
Status
Recruitment Complete
Location
GSK Investigational Site
Bloemfontein, South Africa, 9301
Status
Recruitment Complete
Location
GSK Investigational Site
Bristol, United Kingdom, BS374AX
Status
Recruitment Complete
Location
GSK Investigational Site
Bristol, TN, United States, 37620
Status
Recruitment Complete
Location
GSK Investigational Site
Charleston, SC, United States, 29406
Status
Recruitment Complete
Location
GSK Investigational Site
Charlotte, NC, United States, 28277
Status
Recruitment Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, C1027AAP
Status
Recruitment Complete
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1128AAF
Status
Recruitment Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C199AAB
Status
Recruitment Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1406AGA
Status
Recruitment Complete
Location
GSK Investigational Site
Columbia, MO, United States, 65203
Status
Recruitment Complete
Location
GSK Investigational Site
Columbus, OH, United States, 43215
Status
Recruitment Complete
Location
GSK Investigational Site
Dayton, OH, United States, 45417
Status
Recruitment Complete
Location
GSK Investigational Site
Orlando, FL, United States, 32713
Status
Recruitment Complete
Location
GSK Investigational Site
Houston, TX, United States, 77074
Status
Recruitment Complete
Location
GSK Investigational Site
Houston, TX, United States, 77401
Status
Recruitment Complete
Location
GSK Investigational Site
Jersey City, NJ, United States, 07304
Status
Recruitment Complete
Location
GSK Investigational Site
Johannesburg, South Africa, 2060
Status
Recruitment Complete
Location
GSK Investigational Site
Knoxville, TN, United States, 37938
Status
Recruitment Complete
Location
GSK Investigational Site
Litchfield Park, AZ, United States, 85340
Status
Recruitment Complete
Location
GSK Investigational Site
Little River, SC, United States, 29566
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Argentina, B7600FYK
Status
Recruitment Complete
Location
GSK Investigational Site
McKinney, TX, United States, 75069
Status
Recruitment Complete
Location
GSK Investigational Site
Montpellier cedex 5, France, 34295
Status
Recruitment Complete
Location
GSK Investigational Site
Mount Pleasant, SC, United States, 29464
Status
Recruitment Complete
Location
GSK Investigational Site
Norfolk, VA, United States, 23507
Status
Recruitment Complete
Location
GSK Investigational Site
Normal, IL, United States, 61761
Status
Recruitment Complete
Location
GSK Investigational Site
North Dartmouth, MA, United States, 2747
Status
Recruitment Complete
Location
GSK Investigational Site
Northwood, United Kingdom, HA6 2RN
Status
Recruitment Complete
Location
GSK Investigational Site
Oak Lawn, IL, United States, 60453
Status
Recruitment Complete
Location
GSK Investigational Site
Oklahoma City, OK, United States, 73104
Status
Recruitment Complete
Location
GSK Investigational Site
Orpington, United Kingdom, BR5 3QG
Status
Recruitment Complete
Location
GSK Investigational Site
Philadelphia, PA, United States, 19140
Status
Recruitment Complete
Location
GSK Investigational Site
Portland, OR, United States, 97202
Status
Recruitment Complete
Location
GSK Investigational Site
Pozuelo de Alarcon, Spain, 28223
Status
Recruitment Complete
Location
GSK Investigational Site
Rock Hill, SC, United States, 29732
Status
Recruitment Complete
Location
GSK Investigational Site
Rocky Mount, NC, United States, 27804
Status
Recruitment Complete
Location
GSK Investigational Site
Salt Lake City, UT, United States, 84132
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000IAI
Status
Recruitment Complete
Location
GSK Investigational Site
SANTIAGO DE COMPOSTELA, Spain, 15706
Status
Recruitment Complete
Location
GSK Investigational Site
Scottsdale, AZ, United States, 85248
Status
Recruitment Complete
Location
GSK Investigational Site
Sheveport, LA, United States, 71115
Status
Recruitment Complete
Location
GSK Investigational Site
Somerset West, South Africa, 7130
Status
Recruitment Complete
Location
GSK Investigational Site
St-Charles-Borromee, QC, Canada, J6E 2B4
Status
Recruitment Complete
Location
GSK Investigational Site
St Louis, MO, United States, 63110
Status
Recruitment Complete
Location
GSK Investigational Site
St Louis, MO, United States, 63141
Status
Recruitment Complete
Location
GSK Investigational Site
Trois-Rivieres, QC, Canada, G8T 7A1
Status
Recruitment Complete
Location
GSK Investigational Site
Warwick, RI, United States, 02886
Status
Recruitment Complete
Location
GSK Investigational Site
Williamsburg, VA, United States, 23188
Status
Recruitment Complete
Location
GSK Investigational Site
Winston-Salem, NC, United States, 27103
Status
Recruitment Complete
Location
GSK Investigational Site
Wythenshawe, United Kingdom, M23 9LT
Status
Recruitment Complete
Location
GSK Investigational Site
Paramount, CA, United States, 90723
Status
Recruitment Complete
Location
GSK Investigational Site
Shipley, United Kingdom, BD18 3SA
Status
Recruitment Complete
Location
GSK Investigational Site
Kansas City, KS, United States, 66160
Status
Recruitment Complete
Location
GSK Investigational Site
Lawrenceville, GA, United States, 30046
Status
Study Complete
Location
GSK Investigational Site
Raleigh, NC, United States, 28401
Status
Recruitment Complete
Location
GSK Investigational Site
Gainesville, FL, United States, 32608
Status
Recruitment Complete
Location
GSK Investigational Site
New York, NY, United States, 10016
Status
Terminated/Withdrawn
Location
GSK Investigational Site
HARDERWIJK, Netherlands, 3844 DG
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hialeah, FL, United States, 33016
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Active, not 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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