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This is a double-blind, randomized, 2 period, crossover study in up to 36 healthy and chronic cough subjects.
Approximately 24 chronic cough subjects and 12 healthy subjects who meet all entry criteria will be randomly assigned to AF-219 or placebo.
There will be a Screening period, two Baseline Visits, and two Treatment periods with a minimum of a 48-hour washout period between treatments. Subjects will return two weeks after their last Treatment Visit for a Follow-up Visit.
At Baseline and during each Treatment period, cough sensitivity will be measured by standard clinical methodology incorporating four cough challenges (capsaicin, citric acid, ATP, distilled water).
Daytime cough monitoring will be performed at Baseline and during each of the two treatment periods (cough subjects only).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Refractory Chronic Cough
AF-219, Matching placebo for AF-219
Castle Hill Hospital
Not yet recruiting
Afferent Pharmaceuticals, Inc.
Published on BioPortfolio: 2015-06-23T05:23:23-0400
Chronic cough is a common complain of patients in respiratory clinic and its global prevalence was up to 9.6%. Persistent cough of unexplained origin is a significant health issue that occ...
This is an 8-week randomized, parallel, double-blind, placebo-controlled study of AF-219 in subjects with refractory chronic cough.
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This is a 12-week, randomized, parallel, double-blind, placebo-controlled study of AF-219 in subjects with refractory chronic cough.
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