Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids

Exclusion Criteria

• •Female subjects who have reached menarche.
• •Received any investigational study medication in the 4 weeks prior to Visit 1.
• •Experienced a respiratory tract infection in the 4 weeks prior to Visit 1.
• •Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 12 weeks of Visit 1.
• •Any use of oral/parenteral or depot corticosteroid within 12 weeks of Visit 1.
• •Any use of long-acting inhaled beta2-agonists or oral beta2-agonists within 4 weeks of Visit 1.
• •Any use of leukotriene antagonists or theophyllines within 4 weeks of Visit 1.
• •Any known clinical or laboratory evidence of a serious uncontrolled disease (including serious psychological disorders) which is, in the opinion of the investigator, likely to interfere with the study.
• •Subjects with a known or suspected hypersensitivity to inhaled corticosteroids, beta2-agonists, or any components of the formulations (e.g. lactose)
• •A relative of any of the site staff, including the investigator or study co-coordinator.
• •Has previously been entered into this study.
• •Subjects will be excluded from participating in the treatment period of the study if the following occurred during the run-in period:
• •Pre-bronchodilator FEV1 \<60% (assuming that measurement was correctly performed).
• •Any change in asthma medication (excluding use of prophylactic study specific salbutamol for prevention of asthma symptoms due to exercise).
• •Respiratory tract infection or asthma exacerbation.
• •Use of oral, parenteral or depot corticosteroids.
• •Emergency visit due to asthma.
• •Non-compliance with the completion of the eDRC (i.e. during the 4 week period between visits, non compliance is defined as less than 5 days of completed data within any one week for four weeks - subjects must complete at least 5 days a week for the entire run-in period).