Clinical trial NCT05599191: A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cough
Refractory Chronic Cough
Keywords: Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Cough
Chronic Cough
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: 24-Hour Cough Frequency
timeFrame: Week 12
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52
timeFrame: Up to Week 52
measure: Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 52
timeFrame: Up to Week 52
measure: Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 52
timeFrame: Up to Week 52
measure: Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 52
timeFrame: Up to Week 52
measure: Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 52
timeFrame: Baseline, Week 52
measure: 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
measure: Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52
timeFrame: Baseline, Week 52
measure: 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
measure: Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52
timeFrame: Baseline, Week 52
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 52
timeFrame: Baseline, Week 52
measure: 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
measure: Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 52
timeFrame: Baseline, Week 52
measure: Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 52
timeFrame: Baseline, Week 52
measure: 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:
measure: Change from Baseline in Cough Severity Visual Analogue Scale at Week 12
timeFrame: Baseline, Week 12
measure: 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
measure: Awake Cough Frequency at Week 12
timeFrame: Week 12
measure: Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 12
timeFrame: Baseline, Week 12
measure: Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: 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
measure: Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants with CCD Response at Week 12
timeFrame: Week 12
Other outcomes:
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state: Arizona
city: Scottsdale
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state: Arizona
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state: California
city: Mission Viejo
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state: California
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state: Colorado
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city: Miami
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state: Florida
city: Miami
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facility: GSK Investigational Site
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city: Miami
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facility: GSK Investigational Site
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city: Miami
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city: McKinney
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city: San Antonio
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city: Waco
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city: Williamsburg
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city: Bruxelles
country: Belgium
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city: Gent
country: Belgium
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country: Belgium
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country: Belgium
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state: Alberta
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country: Canada
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state: Alberta
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country: Canada
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country: Canada
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state: Quebec
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country: Canada
facility: GSK Investigational Site
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country: Canada
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country: Canada
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country: Canada
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country: Canada
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country: Canada
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country: Canada
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country: France
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city: Montpellier cedex 5
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country: Hungary
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city: Pecs
country: Hungary
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city: Puspokladany
country: Hungary
facility: GSK Investigational Site
city: Aurangabad
country: India
facility: GSK Investigational Site
city: Bengaluru
country: India
facility: GSK Investigational Site
city: Delhi
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
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city: Kolkata
country: India
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city: Kozhikode
country: India
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city: Nashik
country: India
facility: GSK Investigational Site
city: Nashik
country: India
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city: Pune
country: India
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city: Rohtak
country: India
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city: Thane
country: India
facility: GSK Investigational Site
city: Ulhasnagar
country: India
facility: GSK Investigational Site
city: Hadera
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Petach Tikva
country: Israel
facility: GSK Investigational Site
city: Ramat Gan
country: Israel
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city: Tel Aviv
country: Israel
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city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Arnhem
country: Netherlands
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city: Breda
country: Netherlands
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city: Eindhoven
country: Netherlands
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city: Uden
country: Netherlands
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city: Zutphen
country: Netherlands
facility: GSK Investigational Site
city: Zwolle
country: Netherlands
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Ostrowiec Swietokrzyski
country: Poland
facility: GSK Investigational Site
city: Piaseczno
country: Poland
facility: GSK Investigational Site
city: Rzeszow
country: Poland
facility: GSK Investigational Site
city: Tarnow
country: Poland
facility: GSK Investigational Site
city: Zawadzkie
country: Poland
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Durban
country: South Africa
facility: GSK Investigational Site
city: Durban
country: South Africa
facility: GSK Investigational Site
city: George
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Alcobendas
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Pozuelo de Alarcon
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Corby
country: United Kingdom
facility: GSK Investigational Site
city: Hayle
country: United Kingdom
facility: GSK Investigational Site
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
city: Orpington
country: United Kingdom
facility: GSK Investigational Site
city: Shipley
country: United Kingdom
facility: GSK Investigational Site
city: Wythenshawe
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: