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| ID | Type | Description | Link |
|---|---|---|---|
| BUS-P3-01 | Other Identifier | Bellus Health Inc | |
| 2024-513460-26-00 | Other Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLU-5937 25 mg | Experimental | BLU-5937 oral dose 25 mg twice a day. |
|
| BLU-5937 50 mg | Experimental | BLU-5937 oral dose 50 mg twice a day. |
|
| Placebo | Placebo Comparator | Matching Placebo for BLU-5937 oral dose twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-5937 | Drug | Oral administration of BLU-5937 Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-Hour Cough Frequency | Assessed using an ambulatory cough monitor | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Litchfield Park | Arizona | 85340 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39706278 | Derived | Thach T, Dhanabalan K, Nandekar PP, Stauffer S, Heisler I, Alvarado S, Snyder J, Subramanian R. Mechanistic insights into the selective targeting of P2X3 receptor by camlipixant antagonist. J Biol Chem. 2025 Jan;301(1):108109. doi: 10.1016/j.jbc.2024.108109. Epub 2024 Dec 18. |
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| Placebo | Drug | Oral administration of matching placebo for BLU-5937 Tablets |
|
| Up to Week 52 |
| 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. | Up to Week 52 |
| Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 52 | 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 | Baseline, Week 52 |
| Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52 | 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 | 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 | 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 | Baseline, Week 52 |
| Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 52 | 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 | Baseline, Week 52 |
| Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 52 | 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 | Baseline, Week 52 |
| Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 52 | Baseline, Week 52 |
| Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 52 | 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 | Baseline, Week 52 |
Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity. |
| Baseline, Week 12 |
| Awake Cough Frequency at Week 12 | Assessed using an ambulatory cough monitor | 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 | 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. | 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. | 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. | Baseline, Week 12 |
| Percentage of Participants with CCD Response at Week 12 | Percentage of participants with CCD response will be summarized. | Week 12 |
| Scottsdale |
| Arizona |
| 85248 |
| United States |
| GSK Investigational Site | Encinitas | California | 92024 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Roseville | California | 95661 | United States |
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| GSK Investigational Site | Gainesville | Florida | 32608 | United States |
| GSK Investigational Site | Miami | Florida | 15801 | United States |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D000096822 | Chronic Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000657411 | BLU-5937 |
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