A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-1)
A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-1)
Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Detailed 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 12 weeks.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 675 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, 52-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
Actual Study Start Date: October 25, 2022
Estimated Primary Completion Date: September 2024
Estimated Study Completion Date: July 2025
Arm:
- Experimental: BLU-5937 25 mg
- Experimental: BLU-5937 50 mg
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 675 |
| Actual Study start date | 05 October 2022 |
| Estimated Study Completion Date | 01 July 2025 |