VOLCANO-1 Study
Research type
Research Study
Full title
Evaluation of orvepitant in an exploratory open-label clinical study in chronic treatment-refractory cough
IRAS ID
163952
Contact name
Jaclyn Smith
Contact email
Sponsor organisation
NeRRe Therapeutics Ltd
Eudract number
2014-003947-36
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Cough is a protective reflex which is used to clear the upper airways of irritating material or mucus (phlegm) and yet it is the most common complaint for which people seek medical advice. Most coughs are caused by an infection, such as a cold, which usually settles within 8 weeks. However, some people develop persistent coughing which can last from 8 weeks to several years. This persistent cough is known as ‘chronic cough’. Chronic cough is a common and troublesome problem and is recognised to severely impact on a sufferer’s quality of life. Yet, current cough medicines often fail to help people with the condition.
We are doing this exploratory open-label clinical study to see whether a new drug called Orvepitant helps to relieve the urge to cough by blocking the signals in the brain which tell your body it needs to cough. It has previously been tested in both animals and man in clinical studies (94 healthy volunteers and 516 patients have taken Orvepitant). Orvepitant is currently being tested in a clinical trial in patients who suffer with intense itching; it has not however previously been tested in patients with a chronic cough.
Approximately 15 patients with a diagnosis of chronic cough will be invited to attend the Respiratory and Allergy Clinical Research Facility at the University Hospital of South Manchester NHS Foundation Trust for a total of 5 visits over a period of approximately 8 weeks.
Each patient will be asked to undergo a series of tests to ensure their safety throughout the trial including physical examinations, ECGs, breathing tests, blood and urine tests. Other tests include completion of questionnaires and 24hr cough monitoring during the course of the study.REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/1350
Date of REC Opinion
20 Oct 2014
REC opinion
Favourable Opinion