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 Texas Health Science Center at Houston
Houston, Texas 77401
Houston, Texas 77401
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.