Beclometasone dipropionate (BDP) extrafine is a hydrofluoroalkane-based, 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 200μg day⁻¹ (n=139) or CFC-FP 200μg day⁻¹ (n=141) for up to 18 weeks. After 6 and 12 weeks, study medication was ‘stepped down’ to 100 and 50μg 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 100μg 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.