XENIC: The effects of XEN-D0501 on cough frequency in chronic cough
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled, crossover study to assess the efficacy of XEN-D0501, a TRPV1 antagonist, in reducing the frequency of cough in patients with chronic idiopathic cough.
IRAS ID
147648
Contact name
Jaclyn Smith
Contact email
Sponsor organisation
Xention Limited
Eudract number
2014-000306-36
Research summary
People cough in order to clear their airways. 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. People with chronic cough find the symptom distressing due to the social implications of coughing, and it can have a major impact on their quality of life. There are currently no effective treatments for chronic cough.
It is thought that oversensitive 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 XEN-D0501 at reducing how much a person coughs. XEN-D0501 is a drug known as TRPV1 antagonist. TRPV1 has been shown to play an important role in cough. XEN-D0501 has previously been tested in both animals and man (70 healthy volunteers and 150 patients) and has been generally well tolerated.
This study is a randomised, double-blind, placebo controlled, crossover, study. Patients will be invited to attend Wythenshawe Hospital and Belfast City Hospital over a period of 12 weeks. XEN-D0501 (active drug) and placebo (a dummy tablet with no active ingredient) will be given to 20 patients with chronic cough over two treatment periods. During the study neither the patient, nor the study doctor will know which treatment (active or dummy) is being taken during each treatment period.
Each patient will be asked to undergo a series of tests to ensure their safety throughout the trial including physical examinations, ECGs, blood and urine tests. Other study tests include completion of questionnaires, cough challenge test and 24hr cough monitoring.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0211
Date of REC Opinion
20 May 2014
REC opinion
Further Information Favourable Opinion