This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
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 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
825
24-Hour Cough Frequency
Assessed using an ambulatory cough monitor
Time frame: Week 12
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) 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.
Time frame: Up to Week 52
Number of Participants with Adverse Events of Medical Interest (AEMIs) 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.
Time frame: Up to Week 52
Number of Participants with Study Treatment Discontinuation due to AEs and SAEs 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.
Time frame: Up to Week 52
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GSK Investigational Site
Litchfield Park, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Encinitas, California, United States
GSK Investigational Site
Mission Viejo, California, United States
GSK Investigational Site
Paramount, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Gainesville, Florida, United States
...and 181 more locations
Number of Participants with AEs and SAEs Leading to Study Withdrawal 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.
Time frame: Up to Week 52
Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 52
Time frame: 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
Time frame: Baseline, Week 52
Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 52
Time frame: 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
Time frame: Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 52
Time frame: 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
Time frame: Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 52
Time frame: 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
Time frame: Baseline, Week 52
Change from Baseline in Cough Severity Visual Analogue Scale at 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.
Time frame: 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
Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity.
Time frame: Baseline, Week 12
Awake Cough Frequency at Week 12
Assessed using an ambulatory cough monitor
Time frame: Week 12
Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 12
Assessed using an ambulatory cough monitor
Time frame: Baseline, Week 12
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at 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.
Time frame: Baseline, Week 12
Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at 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.
Time frame: Baseline, Week 12
Change from Baseline in the Chronic Cough Diary (CCD) Score at 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.
Time frame: Baseline, Week 12
Percentage of Participants with CCD Response at Week 12
Percentage of participants with CCD response will be summarized.
Time frame: Week 12