NCT04678206

Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses of BLU-5937 in Adult Participants With Refractory Chronic Cough

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Bellus Health Inc. - a GSK company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Detailed description

The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.

Conditions

• Refractory Chronic Cough

Interventions

Type	Name	Description
DRUG	BLU-5937	Oral administration of BLU-5937 Tablets
DRUG	Placebo	Oral administration of matching placebo for BLU-5937 Tablets

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-10-21
• Completion: 2021-11-02
• First posted: 2020-12-21
• Last updated: 2021-12-13

Locations

116 sites across 7 countries: United States, Canada, Czechia, Germany, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study