A study of the effects of AF-219 on airway hyper-reactivity in asthma
Research type
Research Study
Full title
A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-over Study to evaluate the effect of AF-219 on methacholine hyper-reactivity in subjects with asthma.
IRAS ID
137131
Contact name
Dave Singh
Contact email
Sponsor organisation
Afferent Pharmaceuticals, Inc.
Eudract number
2013-003566-13
Research summary
This is a randomised, double blind, double-dummy, placebo-controlled, three way crossover, single centre study of AF-219 in subjects with asthma undergoing inhalation of methacholine and (Adenosine Triphosphate) ATP. The primary objective is to assess the PC20 response of two dose levels of AF-219 compared with placebo in subjects with asthma after provocation with methacholine. The secondary objectives are to assess the safety and tolerability of a two dose levels of AF-219 compared with placebo after 3.5 days of treatment. The exploratory objective is to assess the response of two dose levels of AF-219 compared with placebo in subjects with asthma after provocation with inhaled ATP. In addition, the relationship between AF-219 plasma concentrations and methacholine and ATP provocation will be explored.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0675
Date of REC Opinion
24 Oct 2013
REC opinion
Favourable Opinion