Extrait

Background and study aims Asthma is a long-term condition which affects the airways. It can affect people of any age, however in usually is first spotted during childhood. When a person is suffering from asthma, the bronchi (tubes which carry air in and out of the lungs) can become narrowed or swollen (inflammation). This causes the sufferer to feel tightness in the chest as the airways become inflamed, causing coughing and difficulty breathing. Most patients with asthma are able to control their condition using medication, however for some patients it is much harder to treat (severe uncontrolled asthma). Xolair is currently licensed in the UK to treat patients with severe asthma but it is clear that not everyone with severe asthma will benefit from treatment. The aim of this study is to investigate the effects of Xolair treatment on the body’s immune system in patients with severe asthma. Who can participate? Adults with severe uncontrolled asthma who have had at least two serious attacks in the last year What does the study involve? All participants are treated with injections under the skin (subcutaneous injections of Xolair at a dose between 75mg and 600mg, based on their weight, for 52 weeks (standard length of treatment). Participants will stay on their standard, pre-study treatments throughout the 52 weeks. Participants are assessed 16 weeks after starting treatment by their physician to find out how well they are responding to treatment. At the same time, participants provide a urine sample so that it can be tested for levels of a chemical called PGD2 which is produced by certain cells in the immune system in asthma. What are the possible benefits and risks of participating? There is a chance that some patients may benefit from better controlled asthma as a result of taking Xolair. There are no notable risks associated with participating. Where is the study run from? Southampton General Hospital (lead centre) and 17 other NHS hospitals in the UK. When is the study starting and how long is it expected to run for? September 2015 to November 2018 Who is funding the study? Novartis Pharma AG (UK) Who is the main contact? Dr Jess Rajaram [email protected]

Critère d'inclusion

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

Liens

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