← Back to all trials
Recruiting
NCT05599191
A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Conditions: Refractory Chronic Cough
Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE3
Enrollment: 675
Sponsor: Bellus Health Inc
Location: United States
Summary
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Eligibility Criteria
Inclusion Criteria:Capable of giving signed informed consentRefractory chronic cough (including unexplained chronic cough) for at least one yearWomen of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last doseExclusion 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 historyDiagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthmaRespiratory tract infection within 4 weeks before screeningLaboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screeningHistory of malignancy in the last 5 yearsHistory of alcohol or drug abuse within the last 3 yearsHas 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
Source: ClinicalTrials.gov (NCT05599191). StuddyBuddy aggregates publicly available trial information.