Extrait

Background and study aims 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 for no reason which can last for many years. This is called chronic cough which is very troublesome and it can have a major impact on the daily life of sufferers. There are very few effective medicines available to treat chronic cough because we don’t fully understand how and why coughing happens. We are doing this research to understand what mechanisms in the body produce coughing and why some people are more prone to developing a chronic cough than others. We will investigate this in this study by testing two different medications. The first one is called Baclofen. Baclofen is a licensed drug which is already used to treat some medical conditions involving the muscles. We already know that Baclofen can also reduce a person’s cough. In this study, we would like to find out if another drug similar to Baclofen can also reduce a person’s cough. The other drug is called Lesogaberan. Lesogaberan is a test medication and is not currently licensed. However, it has already been tested in many trials involving healthy volunteers and patients. Who can participate? To improve knowledge of certain diseases, patients and the public are often asked if they would like to be involved in research studies. This study is open to healthy individuals aged 18 to 70 years. What does the study involve? Taking part involves five visits to the University Hospital of South Manchester NHS Foundation Trust. Participants will be required to perform a capsaicin challenge test (designed to make a person cough), and undergo safety tests which include blood tests, urine tests (women only) and electrocardiograms (ECGs). Participants will also be given tablets containing Baclofen and Lesogaberan on separate occasions. They will also be given a tablet called a placebo. A placebo is a substance that looks the same as the study medicine but it does not contain any active ingredients, it is a ‘dummy’ drug. Neither the study participants nor the researcher will know which drug has been given at each treatment visit. The order of treatment will be allocated at random (like tossing a coin). What are the possible benefits and risks of participating? There will be no direct benefit to participants by taking part in this study. However, we hope that the information we get from this study will help to improve treatment of cough in the future. Baclofen is a licensed drug which is used widely. The most common side effects reported by people taking Baclofen are drowsiness, light-headedness and headache. Lesogaberan is an unlicensed study medication but it has already been tested in several studies involving both healthy volunteers and patients and has been found to be well tolerated. The main side effect experienced by some people is a short-lasting feeling of ‘pins and needles’. During the study participants will be asked to perform a cough challenge test which involves inhaling capsaicin, a component of chilli peppers. Capsaicin can cause tightening of the airways, although this is rare. Breathing tests are performed during and after the test to monitor any chest tightening, which is easily treated by inhaling salbutamol (a medication to open up the airways). Where is the study run from? This study is taking place at the University Hospital of South Manchester NHS Foundation Trust. When is the study starting and how long is it expected to run for? The study started in January 2014 and will run until April 2014. Who is funding the study? Medical Research Council (UK). Who is the main contact? Dr Demi Valdramidou [email protected]

Critère d'inclusion

• Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Liens

• isrctn
• ictrp