Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Phase 2

Completed

• Conditions: Refractory Chronic Cough
• Interventions: Drug: Placebo; Drug: BLU-5937

• Registration Number: NCT04678206
• Lead Sponsor: Bellus Health Inc. - a GSK company

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Detailed Description

The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.

Study Timeline

• Study Start: 2020-12-07
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-21
• Primary Completion: 2021-10-21
• Study Completion: 2021-11-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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 (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo for BLU-5937 oral dose twice a day.
Placebo (Population with baseline cough < 25 coughs/hour)	Placebo	Matching Placebo for BLU-5937 oral dose twice a day.
BLU-5937 Dose A	BLU-5937	BLU-5937 oral dose A twice a day.
BLU-5937 Dose B	BLU-5937	BLU-5937 oral dose B twice a day.
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)	BLU-5937	BLU-5937 oral dose A twice a day.
BLU-5937 Dose C	BLU-5937	BLU-5937 oral dose C twice a day.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the 24-hour cough frequency	Week 4	Assessed using an ambulatory cough monitor

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Leicester Cough Questionnaire (LCQ)	Week 4	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 effect of cough on 3 main 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.
Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)	2 Weeks after the last study medication intake
Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%	Week 4	Assessed using an ambulatory cough monitor
Change from baseline in cough severity	Week 4	Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)	2 Weeks after the last study medication intake

Trial Locations

Locations (115)

Phoenix Medical Research Inc; 🇺🇸 Peoria, Arizona, United States

Little Rock Allergy and Asthma Clinical Research Center; 🇺🇸 Little Rock, Arkansas, United States

Southern California Institute For Respiratory Diseases, Inc; 🇺🇸 Los Angeles, California, United States

Allergy and Asthma Associates of Southern California; 🇺🇸 Mission Viejo, California, United States

California Medical Research Associates, Inc.; 🇺🇸 Northridge, California, United States

Allergy Associates Medical Group Inc.; 🇺🇸 San Diego, California, United States

Allergy and Asthma Associates of Santa Clara Valley Research Center; 🇺🇸 San Jose, California, United States

Colorado Allergy and Asthma Centers; 🇺🇸 Denver, Colorado, United States

St. Francis Medical Institute; 🇺🇸 Clearwater, Florida, United States

Floridian Clinical Research; 🇺🇸 Hialeah, Florida, United States

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