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

RecruitingPhase 3

Sponsor: GlaxoSmithKline

Conditions: Refractory Chronic Cough

Interventions: BLU-5937, Placebo

Countries: China

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (38)

Leshan, Sichuan, China
Beijing, China
Changsha, China
Chengdu, China
Chengdu, China
Chongqing, China
Dongguan, China
Ganzhou, China
Guangzhou, China
Guangzhou, China
Guilin, China
Hangzhou, China
Hefei, China
Hefei, China
Hohhot, China
Huizhou, China
Huizhou, China
Jiangsu, China
Jinan, China
Kunming, China
Liuzhou, China
Meizhou, China
Nanchang, China
Pingxiang, China
Shanghai, China
Shanghai, China
Shanghai, China
Shenyang, China
Shenzhen, China
Taizhou, China
+ 8 more on CT.gov