Status:
COMPLETED
Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Lead Sponsor:
Bellus Health Inc. - a GSK company
Conditions:
Refractory Chronic Cough
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 freq...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04678206
Start Date
December 7 2020
End Date
November 2 2021
Last Update
December 13 2021
Active Locations (116)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Medical Research Inc
Peoria, Arizona, United States, 85381
2
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, United States, 21237
3
Southern California Institute For Respiratory Diseases, Inc
Los Angeles, California, United States, 90048
4
Allergy and Asthma Associates of Southern California
Mission Viejo, California, United States, 92691