A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Purpose

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

Condition

  • Refractory Chronic Cough

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BLU-5937 25 mg 		BLU-5937 oral dose 25 mg twice a day.
  • Drug: BLU-5937
    Oral administration of BLU-5937 Tablets
Experimental
BLU-5937 50 mg 		BLU-5937 oral dose 50 mg twice a day.
  • Drug: BLU-5937
    Oral administration of BLU-5937 Tablets
Placebo Comparator
Placebo 		Matching Placebo for BLU-5937 oral dose twice a day.
  • Drug: Placebo
    Oral administration of matching placebo for BLU-5937 Tablets

Recruiting Locations

University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160

University of Kansas Medical Center Research Institute, Inc.
Wichita, Kansas 67214

More Details

Status
Recruiting
Sponsor
Bellus Health Inc. - a GSK company

Study Contact

US GSK Clinical Trials call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

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.