Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Completed · Phase 2 · Has a placebo group

Conditions studied: Refractory Chronic Cough

In brief

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).

Key facts

Study ID

NCT04678206

Run by

Bellus Health Inc. - a GSK company

People needed

310

Starts

2020-12-07

Expected to finish

2021-11-02

Last updated by the study team

2021-12-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Little Rock Allergy and Asthma Clinical Research Center — Little Rock, Arkansas, United States
• Southern California Institute For Respiratory Diseases, Inc — Los Angeles, California, United States
• Allergy and Asthma Associates of Southern California — Mission Viejo, California, United States
• California Medical Research Associates, Inc. — Northridge, California, United States
• Allergy Associates Medical Group Inc. — San Diego, California, United States
• Allergy and Asthma Associates of Santa Clara Valley Research Center — San Jose, California, United States
• Colorado Allergy and Asthma Centers — Denver, Colorado, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• Floridian Clinical Research — Hialeah, Florida, United States
• Sweet Hope Research Specialty, Inc. — Hialeah, Florida, United States
• Sher Allergy Specialist/Center for Cough — Largo, Florida, United States
• Medical Research of Central Florida — Leesburg, Florida, United States
• ProCare Clinical Research — Miami Lakes, Florida, United States
• Central Florida Pulmonary Group PA — Orlando, Florida, United States
• Lenus Research & Medical Group — Sweetwater, Florida, United States
• IACT Health - Columbus — Columbus, Georgia, United States
• IACT Health - Lawrenceville — Lawrenceville, Georgia, United States
• IACT Health - Rincon — Rincon, Georgia, United States
• Sneeze Wheeze and Itch Associates LLC — Normal, Illinois, United States
• AES - Synexus Clinical Research US, Inc. - Evansville — Evansville, Indiana, United States
• Abraham Research PLLC — Fort Mitchell, Kentucky, United States
• Infinity Medical Research Inc — North Dartmouth, Massachusetts, United States
• Minnesota Lung Center — Edina, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Phoenix Medical Research Inc — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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