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Active (not recruiting) Phase 3 NCT05600777

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Phase 3 – large-scale trial before approval
Conditions: Cough Refractory Chronic Cough

Sponsor: Bellus Health Inc. - a GSK company

trial.available_in: БГ
Overview
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
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 24 weeks.
Who can participate
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, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment * 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
Locations 13
Australia (1)
GSK Investigational Site
Coffs Harbour , New South Wales
Canada (1)
GSK Investigational Site
Calgary , Alberta
China (1)
GSK Investigational Site
Leshan , Sichuan
Czech Republic (1)
GSK Investigational Site
Brandýs nad Labem
Germany (1)
GSK Investigational Site
Berlin
India (1)
GSK Investigational Site
Belagavi
Japan (1)
GSK Investigational Site
Aichi
New Zealand (1)
GSK Investigational Site
Havelock North , Hawke's Bay Region
Slovakia (1)
GSK Investigational Site
Bardejov
South Korea (1)
GSK Investigational Site
Busan
Taiwan (1)
GSK Investigational Site
Changhua
United Kingdom (1)
GSK Investigational Site
Belfast
United States (1)
GSK Investigational Site
Foley , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
05.12.2022
Completion date
17.03.2027
Registry ID
NCT05600777
Source
anzctr
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