Beclometasone dipropionate extrafine aerosol versus fluticasone propionate in children with asthma

Beclometasone dipropionate (BDP) extrafine is a hydrofluoroalkane- based I chlorofluorocarbon (CFC)-free inhalation aerosol. This study was conducted to determine whether BDP extrafine and CFC-fluticasone proprionate (FP) aerosols were equivalent in terms of efficacy and tolerability in children with symptomatic mild-to-moderate asthma. Male and female patients (aged 5-12yr) with an asthma diagnosis for >= 3 months, peak expiratory flow (PEF) >= 60% of predicted normal and suboptimal asthma control were randomised to double-blind treatment with BDP extrafine 200 mu g day(-1) (n = 139) or CFC-FP 200 mu g day(-1) (n = 141) for up to 18 weeks. After 6 and 12 weeks, study medication was 'stepped down' to 100 and 50 mu g day(-1), respectively, if patients had achieved good asthma control. Patients with poor asthma control discontinued from the study and those with intermediate control continued in the study but did not undergo a dose reduction. The estimated treatment difference in morning PEF% predicted at 6 weeks was -1.9% (90% CI -4.9, 1.0). There was a trend towards a greater increase in forced vital capacity (% predicted) in the BDP extrafine group (5.3 versus 0.4%; p = 0.084). A 'step-down' in therapy to 100 mu g day(-1) was possible in 36% and 42% of patients in the BDP extrafine and CFC-FP groups, respectively, at 6 weeks. Both drugs were well tolerated. BDP extrafine and CFC-FP aerosols were equally effective at improving asthma control in children with mild-to-moderate asthma at the same daily dose. (C) 2006 Elsevier Ltd. All rights reserved.