FLUTICASONE PROPIONATE COMPARED WITH BUDESONIDE - A DOUBLE-BLIND TRIAL IN ASTHMATIC-CHILDREN USING POWDER DEVICES AT A DOSAGE OF 400 MU-G-CENTER-DOT-DAY(-1)

The aim of this study was to compare fluticasone propionate (FP) with budesonide (BUD) at a dose of 400 mu g . day(-1) in the treatment of c hildren with asthma, Two hundred and twenty nine children with mild-to -moderate asthma, currently receiving 200-400 mu g . day(-1) of inhale d corticosteroid, were randomized to receive either 400 mu g . day(-1) of FP from the Diskhaler(TM) (registered trade mark of the Glare Grou p of Companies) or 400 mu g . day(-1) of BUD from the Turbuhaler(TM) ( registered trade mark of Astra Pharmaceuticals Ltd) for 8 weeks, in a parallel-group, double-blind, double-dummy study, Primary efficacy was assessed by measurement of daily peak expiratory now (PEF). In additi on, pulmonary function tests were performed at each clinic visit and a self-administered patient-centred questionnaire was completed by one parent of each patient at the start and end of study treatment. Mean m orning PEF increased following treatment both with FP and BUD, but was significantly higher following treatment with FP during Weeks 1-4 (p= 0.015) and Weeks 1-8 (p=0.019). Similar results were found for mean ev ening PEF and percentage predicted morning and evening PEF, Children r eceiving FP experienced significantly less disruption in their physica l activities (i.e. sports, games) because of their asthma compared to children treated with BUD (p=0.03). Mean cortisol levels increased in both groups, but the increase was significantly higher in the FP group at 4 weeks (p=0.022). Serum and urine markers of bone formation and r esorption changed very little and showed no consistent pattern of chan ge. Fluticasone propionate at a dosage of 400 mu g . day(-1) from the Diskhaler(TM) provided a more rapid and greater improvement in lung fu nction in children with mild-to-moderate asthma than BUD 400 mu g day( -1) from the Turbuhaler(TM). Both treatments were well-tolerated, with a similar safety profile.