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Effect of AF-219 on Cough Reflex Sensitivity (Cough Challenge)

2015-06-23 05:23:23 | BioPortfolio

Summary

This is a double-blind, randomized, 2 period, crossover study in up to 36 healthy and chronic cough subjects.

Description

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Refractory Chronic Cough

Intervention

AF-219, Matching placebo for AF-219

Location

Castle Hill Hospital
Hull
United Kingdom
HU16 5JQ

Status

Not yet recruiting

Source

Afferent Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-23T05:23:23-0400

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