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
| 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
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
Kansas City, Kansas 66160
University of Kansas Medical Center Research Institute, Inc.
Wichita, Kansas 67214
Wichita, Kansas 67214
More Details
- 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 12 weeks.