EPiCC: Efficacy of AF-219 in Chronic Cough

• Research type

  Research Study

• Full title

  A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects with Chronic Cough

• IRAS ID

  78874

• Contact name

  Jaclyn A Smith / Danielle Yuill

• Sponsor organisation

  Afferent Pharmaceuticals, Inc.

• Eudract number

  2010-024283-18

• Research summary

  Coughing is an important defensive mechanism. Most coughs are caused by viruses and settle down by themselves, but some people develop persistent coughing which can last anywhere from 8 weeks to several years. This is called chronic cough. There are currently no effective treatments for this. It is thought that over-sensitive airway nerves might play an important part in why some People'suffer with chronic cough, but currently it is not known how or why people develop sensitive airways. This study aims to test the effectiveness of a new drug known as AF-219 at improving a sufferer??s cough and lessening the impact it has on their day to day activities. AF-219 was originally developed for the treatment of chronic pain. The drug has been tested in animals and 112 healthy volunteers. This study is a randomised, double-blind, placebo-controlled, crossover, single centre study. Patients will be invited to attend Wythenshawe Hospital over a period of 10 weeks. Either AF-219 or a placebo will be given to 25 treatment resistant chronic cough patients over a 2 week period. This will be followed by 2 weeks without treatment (called washout) and then another 2 weeks of AF-219 or placebo treatment (called a crossover). During the study all patients will receive AF-219 and placebo, but neither the patient, nor the study doctor will know which one the patient is taking during each 2 week treatment period (double-blind). Both AF-219 and placebo will be administered as identical tablets twice daily.During the study each patient will be asked to undergo a series of tests including a chest x-ray and ultrasound scans, electrocardiograms, donating blood and urine samples, completing questionnaires, lung function testing, and wearing a device which records your cough for 24 hours.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  11/NW/0231

• Date of REC Opinion

  20 May 2011

• REC opinion

  Favourable Opinion