AF219-014 Cough Reflex Sensitivity in Healthy & Chronic Cough Subjects
Research type
Research Study
Full title
A Study to Assess the Effect of AF-219 on Cough Reflex Sensitivity in Both Healthy and Chronic Cough Subjects
IRAS ID
184954
Contact name
Alyn Morice
Contact email
Sponsor organisation
Afferent Pharmacuticals
Eudract number
2015-002034-47
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
There is currently no treatment available for patients with Refractory Chronic Cough. This study will assess the effect of a single daily dose of 100mg of AF219 on cough reflex sensitivity in chronic cough and healthy volunteers. This will be measured using a cough monitor (recording device), an urge to cough & cough severity VAS and the Hull Airway Reflux Questionnaire.
This is a phase II, randomised, 2 period, crossover study involving approximately 24 chronic cough subjects and 12 healthy volunteers. In each of the 2 treatment periods the subjects will receive 1 dose of AF219 and after this dose the cough reflex sensitivity will be measured by standard clinical methodology incorporating capsaicin, ATP, citric acid and distilled water. These cough challenges are proven methods of inducing a cough in humans and involve inhaling the above listed cough stimulating substances at standard doses through the mouth. All 4 substances are known to be safe and free of any serious side effects.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0400
Date of REC Opinion
12 Oct 2015
REC opinion
Further Information Favourable Opinion