Extrait

Background and study aims Your nervous system allows your body to respond to changes in the environment by sending messages back and forth from the brain to different parts of your body. Your heart rate and blood pressure are controlled by your autonomic nervous system. Your heart rate and blood pressure change throughout the day, often in response to changes in your environment, such as standing up from a sitting position, or a change in temperature. In some people the autonomic nervous system does not always function correctly which can lead to problems such as light headiness or even fainting. Autonomic nervous system dysfunction has previously been studied in patients with other hypersensitivity disorders, such as asthma, but has not been previously studied in patients with chronic cough. This study aims to study autonomic function in people with chronic cough and healthy individuals to see whether there are any differences between the two groups. Who can participate? The study aims to recruit 20 chronic cough patients and 10 healthy volunteers with the same age distribution and proportion of males and females in each group. What does the study involve? This study involves three visits to the University Hospital of South Manchester. Visit 1 involves measuring and recording heart rate and blood pressure, an electrocardiogram (ECG), completion of three questionnaires designed to understand how coughing affects your daily life, a simple lung function test called spirometry, and fitting of a cough monitor, which is designed to record the number of times you have coughed during the day and how long for. This visit is anticipated to last about 1 hour. Visit 2 is a short visit and involves a cough challenge only, which is a test designed to make you to cough. This visit is anticipated to last about 30 minutes. Visit 3 is anticipated to last about 2 hours and 30 minutes and requires participants to fast for 4 hours prior to their appointment. Tests will be performed which are designed to affect blood pressure and heart rate, both of which will be monitored throughout the visit with respiratory bands, an ECG monitor and a beat-to-beat blood pressure monitor. What are the possible benefits and risks of participating? There will be no direct benefit for participants in this study. We hope that the results of this study will help us to understand the mechanisms of chronic cough. During the study you will be asked to perform a cough challenge 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). A number of autonomic function tests will be performed during this study. These tests are designed to cause changes in your blood pressure and heart rate. As such these tests may make you feel light headed or even cause you to faint. If you do feel unwell you must tell a researcher. A doctor will be present during all autonomic function testing. Where is the study run from? This is a single centre study being conducted at the University Hospital of South Manchester. Healthy volunteers are being recruited from a list of volunteers stored in the North West Lung Research Centre at the University Hospital of South Manchester and chronic cough patients are being recruited from the tertiary referral cough clinic hosted by the University Hospital of South Manchester. When is the study starting and how long is it expected to run for? The study started recruiting in August 2013 and is expected to run until April 2014. Who is funding the study? University of Manchester, UK. Who is the main contact? Mrs Rachel Dockry, Research Assistant [email protected]

Critère d'inclusion

• Chronic Cough

Liens

• ictrp
• isrctn