Extrait

Background and study aims Allergic asthma is the most common type of asthma, where symptoms such as coughing, wheezing, chest tightness and breathlessness begin when the body reacts to something it is allergic to. Omalizumab is a drug licensed for the treatment of severe allergic asthma. A study has demonstrated that use of omalizumab reduces oral corticosteroid use, hospitalisations and A&E visits, and increases patients’ quality of life. In order to follow on from and reinforce the findings from this study, we are now undertaking a further study to collect data from the point of decision to prescribe omalizumab. Who can participate? Patients aged 16 and over who are going to receive at least one dose of omalizumab for the treatment of severe persistent allergic asthma as part of normal clinical care. What does the study involve? Patients are treated as per standard clinical practice with omalizumab, but are also requested to complete a breathing test and questionnaires about asthma and their quality of life after 16 weeks, 8 months and 12 months. There is therefore little deviation from standard omalizumab care from the patients’ perspective. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? Novartis Pharmaceuticals (UK) When is the study starting and how long is it expected to run for? March 2012 to August 2013 Who is funding the study? Novartis Pharmaceuticals (UK) Who is the main contact? Dr Amr Radwan

Critère d'inclusion

• Severe allergic asthma (consistent with the licence for omalizumab)

Liens

• isrctn
• ictrp