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| ID | Type | Description | Link |
|---|---|---|---|
| BUS-P3-02, | Other Identifier | Bellus Health Inc |
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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 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLU-5937 25 mg | Experimental | BLU-5937 oral dose 25 mg twice a day. |
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| BLU-5937 50 mg | Experimental | BLU-5937 oral dose 50 mg twice a day. |
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| Placebo | Placebo Comparator | Matching Placebo for BLU-5937 oral dose twice a day. |
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| 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 24 |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24 | 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 24 |
| Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24 | 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 24 |
| Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24 | 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 24 | 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 24 |
| Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analog Scale at Week 24 |
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Inclusion Criteria:
Capable of giving signed informed consent
Refractory chronic cough (including unexplained chronic cough) for at least one year
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Leshan | Sichuan | 614003 | China |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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The study includes a single-blind placebo run-in followed by a double-blind treatment period with centralized randomization identical investigational product presentation and restricted access to treatment assignments except for emergency unblinding. Additionally a study specific masking plan incorporates a masking strategy by restricting access to potentially treatment unblinding data.
| Placebo | Drug | Oral administration of matching placebo for BLU-5937 Tablets. |
|
| Up to Week 24 |
| Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24 | 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 24 |
| Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 24 | 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 | Baseline, Week 24 |
| Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 24 | 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 | 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 | 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 | Baseline, Week 24 |
| Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 24 | 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 | Baseline, Week 24 |
| Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 24 | 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 | Baseline, Week 24 |
| Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 24 | Baseline, Week 24 |
| Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 24 | 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 | Baseline, Week 24 |
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 24 |
| Awake Cough Frequency at Week 24 | Assessed using an ambulatory cough monitor | Week 24 |
| Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 24 | Assessed using an ambulatory cough monitor | Baseline, Week 24 |
| Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24 | 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 24 |
| Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24 | 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 24 |
| Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 24 | 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 24 |
| Percentage of Participants with CCD Response at Week 24 | Percentage of participants with CCD response will be summarized. | Week 24 |
| GSK Investigational Site | Recruiting | Beijing | 100730 | China |
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| GSK Investigational Site | Recruiting | Changsha | 410008 | China |
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| GSK Investigational Site | Recruiting | Chengdu | 610021 | China |
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| GSK Investigational Site | Recruiting | Chengdu | 610041 | China |
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| GSK Investigational Site | Recruiting | Chongqing | 408099 | China |
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| GSK Investigational Site | Recruiting | Dongguan | 523326 | China |
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| GSK Investigational Site | Recruiting | Ganzhou | 341000 | China |
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| GSK Investigational Site | Recruiting | Guangzhou | 510000 | China |
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| GSK Investigational Site | Recruiting | Guangzhou | 510260 | China |
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| GSK Investigational Site | Recruiting | Guilin | 541002 | China |
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| GSK Investigational Site | Recruiting | Hangzhou | 310003 | China |
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| GSK Investigational Site | Recruiting | Hefei | 230001 | China |
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| GSK Investigational Site | Recruiting | Hefei | 230022 | China |
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| GSK Investigational Site | Recruiting | Hohhot | 010017 | China |
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| GSK Investigational Site | Recruiting | Huizhou | 516000 | China |
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| GSK Investigational Site | Recruiting | Huizhou | 516001 | China |
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| GSK Investigational Site | Recruiting | Jiangsu | 221004 | China |
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| GSK Investigational Site | Recruiting | Jinan | 250021 | China |
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| GSK Investigational Site | Recruiting | Kunming | 650032 | China |
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| GSK Investigational Site | Recruiting | Liuzhou | China |
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| GSK Investigational Site | Recruiting | Meizhou | 514700 | China |
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| GSK Investigational Site | Recruiting | Nanchang | 330038 | China |
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| GSK Investigational Site | Recruiting | Pingxiang | 337055 | China |
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| GSK Investigational Site | Recruiting | Shanghai | 200032 | China |
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| GSK Investigational Site | Recruiting | Shanghai | 200065 | China |
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| GSK Investigational Site | Recruiting | Shanghai | 200080 | China |
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| GSK Investigational Site | Recruiting | Shenyang | 110004 | China |
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| GSK Investigational Site | Recruiting | Shenzhen | 518053 | China |
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| GSK Investigational Site | Recruiting | Taizhou | 317000 | China |
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| GSK Investigational Site | Recruiting | Ürümqi | 830001 | China |
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| GSK Investigational Site | Recruiting | Weifang | China |
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| GSK Investigational Site | Recruiting | Wuxi | 214023 | China |
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| GSK Investigational Site | Recruiting | Xiamen | 361004 | China |
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| GSK Investigational Site | Recruiting | Yangzhou | 225001 | China |
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| GSK Investigational Site | Recruiting | Yinchuan | China |
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| GSK Investigational Site | Recruiting | Zhanjiang | 524045 | China |
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| GSK Investigational Site | Recruiting | Zhengzhou | 450052 | China |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000657411 | BLU-5937 |
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