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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
310
Change from baseline in the 24-hour cough frequency
Assessed using an ambulatory cough monitor
Time frame: Week 4
Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%
Assessed using an ambulatory cough monitor
Time frame: Week 4
Change from Baseline in Leicester Cough Questionnaire (LCQ)
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the effect of cough on 3 main domains: physical, psychological and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.
Time frame: Week 4
Change from baseline in cough severity
Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate worse severity.
Time frame: Week 4
Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)
Time frame: 2 Weeks after the last study medication intake
Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)
Time frame: 2 Weeks after the last study medication intake
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Phoenix Medical Research Inc
Peoria, Arizona, United States
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, United States
Southern California Institute For Respiratory Diseases, Inc
Los Angeles, California, United States
Allergy and Asthma Associates of Southern California
Mission Viejo, California, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Allergy Associates Medical Group Inc.
San Diego, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, United States
St. Francis Medical Institute
Clearwater, Florida, United States
Floridian Clinical Research
Hialeah, Florida, United States
...and 106 more locations