GARMIN-II: double-blind randomised controlled trial of lesogaberan in cough
Research type
Research Study
Full title
The Role of GABAb receptor mechanisms in cough: Double-blind randomised controlled trial of Lesogaberan in Chronic cough patients with positive and negative symptom association probabilities
IRAS ID
166166
Contact name
Jaclyn Smith
Contact email
Eudract number
2014-005074-11
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Cough is a protective reflex which is used to clear the 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 can severely impact on a sufferer’s life. Yet, current cough medicines often fail to help.
This study (a randomised, double-blind, placebo controlled, crossover study) aims to test the effectiveness of a drug known as AZD3355 (Lesogaberan). Lesogaberan was originally developed by AstraZeneca for the treatment of gastroesophageal reflux disease but it is thought that it might be helpful in reducing coughing in patients with a chronic cough.
We are looking for 50 patients with a chronic cough to attend the University Hospital South Manchester over a period of 13 weeks. Lesogaberan and placebo (a dummy tablet with no active ingredient) will be given to patients 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, 24hour cough monitoring and oesophageal high resolution and pH impedance manometry.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1497
Date of REC Opinion
19 Dec 2014
REC opinion
Favourable Opinion