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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGlaxoSmithKline

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BLU-5937
  • Placebo

Treatment groups

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators