Extrait

Background and study aims 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 associated with poor quality of life. Current cough medicines often fail to help people with chronic cough and up to 40% of chronic cough cases have an unknown cause. We are doing this research to help us understand why some people develop chronic cough and how their cough compares with healthy individuals. Who can participate? In this study we aim to recruit 96 healthy volunteers and 96 patients with chronic cough, male and female aged over 18 years. What does the study involve? The study involves two short visits to the North West Lung Centre at the University Hospital of South Manchester NHS Foundation Trust, Wythenshawe. Participants will be asked if they are willing to return to the hospital for an optional third visit until a total of 10 chronic cough and 10 healthy volunteers have agreed to do so. Visit 1 will last about 1 hour. A researcher will ask participants questions about their medical history, lifestyle and details of any medications they may be taking. Their height and weight will be measured and recorded. Chronic cough patients will be asked to complete a short questionnaire about their cough and how it affects their daily life and activities. During this visit participants will be asked to perform a simple lung function test called spirometry. Lastly, they will be fitted with a cough monitor which will record the number of times they cough over a period of 24 hours during the day and night. Visit 2 will last for about 1 hour and will take place at least 24 hours after visit 1 but within 2 weeks. During this visit the cough monitor will be returned. Participants will then be asked to perform a cough challenge, which is a test designed to make you cough. A researcher will perform some breathing tests before the start of the test to ensure it is safe for participants to undergo the challenge. The cough monitor will be re-attached for the duration of the test to capture coughing. Participants will be asked to take a breath of a weak solution called capsaicin (chilli pepper extract) through a nebulizer machine. The process will be repeated several times with gradually increasing strengths of capsaicin. At the end of the challenge, the breathing tests will be repeated to ensure participants have not experienced chest tightening. Visit 3 is an optional visit that will take place up to 2 weeks after visit 2. Participants will be asked to perform breathing tests, be fitted with a cough monitor (just for the duration of the cough challenge), undergo a cough challenge, perform breathing tests again and complete a short questionnaire. What are the possible benefits and risks of participating? There will be no direct benefit for participants in this study. However, we hope that the results of this study will help us to understand the mechanisms of chronic cough and improve treatments in the future. We do not expect any significant risks associated with taking part in this study. Capsaicin (chilli pepper extract) inhalation is a well-established safe technique and no associated serious adverse events have been reported. Main side effects are an irritation or ‘burning sensation’ at the back of the throat. Where is the study run from? This is a single-centre study taking place at the University Hospital of South Manchester NHS Foundation Trust, Wythenshawe. The chronic cough patients will be randomly recruited from our specialist cough clinic at Wythenshawe Hospital. Healthy volunteers are currently being recruited from the local area. When is the study starting and how long is it expected to run for? The recruitment started in August 2013 and is expected to be complete by August 2014. Who is funding the study? The University of Manchester, UK. Who is the main contact? Miss Kimberley Holt, Research Assistant [email protected]

Critère d'inclusion

• Chronic Cough

Liens

• ictrp
• isrctn