seretide versus flixotide in asthmatic children not controlled by inhaled corticosteroids

Conditions: Asthma

Summary: this study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. the fixed combination seretide 100/50 one inhalation twice daily will be compared to flixotide 100 two inhalations twice daily.

a multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (seretide™) at a dose of 50/100mcg twice daily and fluticasone propionate (flixotide™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (diskus™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose

Eligibility criteria:
inclusion criteria: * a documented clinical history of asthma for a period of at least 6 months. * a documented history (within 12 months of visit 1) of airway reversibility of = 15% based either on forced expiratory volume (fev1) or pef measured pre and post inhalation of 200 mcg salbutamol. (if no documented history of reversibility exists, patients must demonstrate a =15% reversibility at visit 1). * receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate hydrofluoroalkane (hfa) non fine particle = 400-500 mcg/day or beclomethasone hfa fine particle = 200mcg/day, or budesonide =400 mcg/day or fluticasone = 200 mcg/day (or fluticasone 250mcg/day if subject is taking a 125mcg mdi rather than the 100mcg diskus), for at least 3 months prior to visit 1 and at a stable dose for at least 4 weeks prior to visit 1. * able to use the mini-wright peak flow meter and subject or parent/guardian had to be able to record the subject's maximum pef correctly. * able to perform fev1 correctly. * subject's guardian/parent able to complete an edrc on behalf of the subject. the edrc should be completed by the guardian/parent. * able to use a diskus™ correctly. * at least one parent(s)/guardian(s) has to give written informed consent to participate in the study. at the end of the run-in period (visit 2), subjects must still meet the criteria for entry into the run-in period and also have: * not achieved the criteria for the 'well-controlled' asthma during two or more of the 4 weeks prior to visit 2. 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).

Keywords: flixotide asthmatics children 4-11 years seretide asthma-control