A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Condition(s) studied

Investigational drug(s) / intervention(s)

BLU-5937: Oral administration of BLU-5937 Tablets

Placebo: Oral administration of matching placebo for BLU-5937 Tablets

Study summary

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Eligibility

Primary outcome measure(s)

• 24-Hour Cough Frequency — Week 24
  Assessed using an ambulatory cough monitor
• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24 — 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.
• Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24 — 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.
• Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24 — 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.
• Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24 — 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.
• 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

Trial sites (242)

+ 202 more sites — see the full list on the official registry below.