This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
This study will have two 21-day treatment periods separated by a 14-day washout period. There will be a 14-day follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Three different doses over the course of the study
Matching placebo for Bradanicline
BioSolutions Clinical Research Center
La Mesa, California, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
Awake coughs per hour at Days 7, 14, 21, 43, 50, 57
Assessment of awake coughs per hour (average hourly cough frequency while the participant is awake based on sound recordings), to be evaluated using a digital recording device
Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57
24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57
Assessment of 24-hour coughs per hour (average hourly cough frequency based on 24-hour sound recordings), to be evaluated using a digital recording device
Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57
Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up
Assessment of participants who have at least one AE during treatment period 1 (21 days), during washout (14 days), during treatment period 2 (21 days), and follow-up (14 days)
Time frame: up to 57 days
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Asthma and Allergy Associates
Colorado Springs, Colorado, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Center
Denver, Colorado, United States
Center for Cough
Largo, Florida, United States
Florida Pulmonary Research Institute
Winter Park, Florida, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Mayo Clinic, Pulmonary Clinic Research Unit
Rochester, Minnesota, United States
Atlantic Research Center, LLC
Ocean Township, New Jersey, United States
...and 7 more locations