Extrait

Background and study aims Chronic obstructive pulmonary disease (COPD) is a common lung condition usually caused by smoking. The lungs become baggy and full of holes. Patients are unable to breathe out fully. This 'gas trapping' causes breathlessness, exercise limitation and poor quality of life and although tablets and inhalers provide some benefit many people are still very limited by their disease. A different approach is to use a fibreoptic camera (bronchoscope) to place valves into the airways of the lung to prevent air from entering the most over-inflated part. If the most damaged area of lung can be made to collapse this way it makes more space for the remaining healthier lung to function. Unfortunately, in many patients lung destruction breaks down the barriers (fissures) between the target lobe and adjacent lung, which allows to 'get round behind' the valves so that the lung does not collapse. Who can participate? Adult emphysema patients with intact interlobar fissures on their CT scan, the pattern that is most likely to respond. What does the study involve? Participants will be randomly allocated into one of two groups. One group will have valves placed to occlude the worst affected lobe of their lungs and the other group will have a bronchoscopy performed but no valves placed. This 'sham' bronchoscopy is acceptable to patients and has been used safely in other trials. Response to treatment will be assessed 90 days after the procedure. The primary outcome will be improvement in lung function but we will also look at changes in exercise capacity and health-related quality of life. What are the possible benefits and risks of participating? There is about a 1 in 20 risk of the lung that we have targeted collapsing. This is called a pneumothorax. This may cause chest pain and an increase in breathlessness but sometimes just shows up on a chest x-ray. If this does happen it may resolve spontaneously or we may need to insert a tube into your chest to let the air escape which could require you to spend a few days in hospital. Where is the study run from? The study is being run from the National Institute for Health Research (NIHR) Respiratory Biomedical Research Unit at Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (UK). When is the study starting and how long is it expected to run for? The study will start in March 2012 and run for 2 years. Who is funding the study? This research grant has been awarded by the Efficacy and Mechanism Evaluation (EME) programme, which is funded by the Medical Research Council (MRC) and managed by the NIHR. Who is the main contact? Dr Nicholas Hopkinson [email protected]

Critère d'inclusion

• COPD - heterogeneous emphysema

Liens

• ictrp
• isrctn