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Активно (без набиране) Фаза 3 NCT05600777

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Cough Refractory Chronic Cough

Спонсор: Bellus Health Inc. - a GSK company

Налично на: БГ
Обобщение
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Описание
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.
Кой може да участва
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
Места на провеждане 13
Австралия (1)
GSK Investigational Site
Coffs Harbour , New South Wales
Канада (1)
GSK Investigational Site
Calgary , Alberta
Китай (1)
GSK Investigational Site
Leshan , Sichuan
Чехия (1)
GSK Investigational Site
Brandýs nad Labem
Германия (1)
GSK Investigational Site
Berlin
Индия (1)
GSK Investigational Site
Belagavi
Япония (1)
GSK Investigational Site
Aichi
New Zealand (1)
GSK Investigational Site
Havelock North , Hawke's Bay Region
Словакия (1)
GSK Investigational Site
Bardejov
Южна Корея (1)
GSK Investigational Site
Busan
Taiwan (1)
GSK Investigational Site
Changhua
Великобритания (1)
GSK Investigational Site
Belfast
САЩ (1)
GSK Investigational Site
Foley , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
05.12.2022
Крайна дата
17.03.2027
Регистрационен номер
NCT05600777
Източник
anzctr
Запитване за медицински туризъм

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