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A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

Refractory Chronic Cough Clinical Trial

Official title:
A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05600777
Study type Interventional
Source Bellus Health Inc. - a GSK company
Contact US GSK Clinical Trials call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Status Recruiting
Phase Phase 3
Start date January 13, 2023
Completion date June 2026
View Details
See also
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Completed NCT02476890 - Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014) Phase 2
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Not yet recruiting NCT06213363 - A Phase Ib/II Clinical Study in Patients With Refractory Chronic Cough Phase 1/Phase 2
Completed NCT02412020 - Treatment of Refractory Chronic Cough With PA101 Phase 2
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Completed NCT02612623 - An 8-Week Refractory Chronic Cough Study (MK-7264-021) Phase 2
Completed NCT02612610 - A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012) Phase 2
Completed NCT02397460 - Effect of Gefapixant (AF-219/MK-7264) on Cough Reflex Sensitivity (MK-7264-015) Phase 2
Not yet recruiting NCT05265871 - ATP Level and Cough Sensitivity to ATP in Subjects With Refractory Chronic Cough