A 24-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).
Conditions
- Cough
- Refractory Chronic Cough
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- 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, 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
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BLU-5937 25 mg |
BLU-5937 oral dose 25 mg twice a day. |
|
|
Experimental BLU-5937 50 mg |
BLU-5937 oral dose 50 mg twice a day. |
|
|
Placebo Comparator Placebo |
Matching Placebo for BLU-5937 oral dose twice a day. |
|
Recruiting Locations
GSK Investigational Site
Foley 4062644, Alabama 4829764 36535
Foley 4062644, Alabama 4829764 36535
GSK Investigational Site
Phoenix 5308655, Arizona 5551752 85032
Phoenix 5308655, Arizona 5551752 85032
GSK Investigational Site
Los Angeles 5368361, California 5332921 90025
Los Angeles 5368361, California 5332921 90025
GSK Investigational Site
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
GSK Investigational Site
Paramount 5381110, California 5332921 90723
Paramount 5381110, California 5332921 90723
GSK Investigational Site
San Diego 5391811, California 5332921 92120
San Diego 5391811, California 5332921 92120
GSK Investigational Site
San Jose 5392171, California 5332921 95117
San Jose 5392171, California 5332921 95117
GSK Investigational Site
Aurora 5412347, Colorado 5417618 80012
Aurora 5412347, Colorado 5417618 80012
GSK Investigational Site
Colorado Springs 5417598, Colorado 5417618 80923
Colorado Springs 5417598, Colorado 5417618 80923
GSK Investigational Site
Wheat Ridge 5443948, Colorado 5417618 96001
Wheat Ridge 5443948, Colorado 5417618 96001
GSK Investigational Site
Washington D.C. 4140963, District of Columbia 4138106 20007
Washington D.C. 4140963, District of Columbia 4138106 20007
GSK Investigational Site
Daytona Beach 4152872, Florida 4155751 32117
Daytona Beach 4152872, Florida 4155751 32117
GSK Investigational Site
Fort Lauderdale 4155966, Florida 4155751 33324
Fort Lauderdale 4155966, Florida 4155751 33324
GSK Investigational Site
Jacksonville 4160021, Florida 4155751 32224
Jacksonville 4160021, Florida 4155751 32224
GSK Investigational Site
Leesburg 4161771, Florida 4155751 34748
Leesburg 4161771, Florida 4155751 34748
GSK Investigational Site
Sarasota 4172131, Florida 4155751 34239
Sarasota 4172131, Florida 4155751 34239
GSK Investigational Site
Sweetwater 4174600, Florida 4155751 33172
Sweetwater 4174600, Florida 4155751 33172
GSK Investigational Site
Cumming 4190396, Georgia 4197000 30041
Cumming 4190396, Georgia 4197000 30041
GSK Investigational Site
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
GSK Investigational Site
River Forest 4907637, Illinois 4896861 60305
River Forest 4907637, Illinois 4896861 60305
GSK Investigational Site
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
GSK Investigational Site
Chevy Chase 4351335, Maryland 4361885 20815
Chevy Chase 4351335, Maryland 4361885 20815
GSK Investigational Site
Methuen 4943828, Massachusetts 6254926 01844
Methuen 4943828, Massachusetts 6254926 01844
GSK Investigational Site
North Dartmouth 4945601, Massachusetts 6254926 02747
North Dartmouth 4945601, Massachusetts 6254926 02747
GSK Investigational Site
St Louis 4407066, Missouri 4398678 63105
St Louis 4407066, Missouri 4398678 63105
GSK Investigational Site
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
GSK Investigational Site
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
GSK Investigational Site
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
GSK Investigational Site
Missoula 5666639, Montana 5667009 59808
Missoula 5666639, Montana 5667009 59808
GSK Investigational Site
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68124
GSK Investigational Site
Gastonia 4467732, North Carolina 4482348 28054
Gastonia 4467732, North Carolina 4482348 28054
GSK Investigational Site
Winston-Salem 4499612, North Carolina 4482348 27103
Winston-Salem 4499612, North Carolina 4482348 27103
GSK Investigational Site
Columbus 4509177, Ohio 5165418 43235
Columbus 4509177, Ohio 5165418 43235
GSK Investigational Site
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97213
GSK Investigational Site
Danville 5186327, Pennsylvania 6254927 17822
Danville 5186327, Pennsylvania 6254927 17822
GSK Investigational Site
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
GSK Investigational Site
Warwick 5225507, Rhode Island 5224323 02886
Warwick 5225507, Rhode Island 5224323 02886
GSK Investigational Site
Anderson 4569298, South Carolina 4597040 29621
Anderson 4569298, South Carolina 4597040 29621
GSK Investigational Site
Charleston 4574324, South Carolina 4597040 29412
Charleston 4574324, South Carolina 4597040 29412
GSK Investigational Site
Dallas 4684888, Texas 4736286 75231-4307
Dallas 4684888, Texas 4736286 75231-4307
GSK Investigational Site
San Antonio 4726206, Texas 4736286 78258
San Antonio 4726206, Texas 4736286 78258
GSK Investigational Site
Norfolk 4776222, Virginia 6254928 23507
Norfolk 4776222, Virginia 6254928 23507
More Details
- NCT ID
- NCT05600777
- Status
- Recruiting
- Sponsor
- Bellus Health Inc. - a GSK company
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 24 weeks.