COMPARISON OF THE EFFICACY AND SAFETY OF INHALED FLUTICASONE PROPIONATE 200 MG DAY WITH INHALED BECLOMETHASONE DIPROPIONATE 400 MG DAY IN MILD AND MODERATE ASTHMA

This study was designed to compare the efficacy and safety of a new in haled corticosteroid, fluticasone propionate at a total daily dose of 200 mug, with beclomethasone dipropionate 400 mug/day in childhood ast hma. A total of 398 asthmatic children (aged 4-19 years) were randomis ed to receive either fluticasone propionate 200 mug daily or beclometh asone dipropionate 400 mug daily for six weeks inhaled via a spacer de vice from a metered dose inhaler. During the study the patients record ed morning and evening peak expiratory flow rate (PEFR), symptom score s, and use of beta2 agonist rescue medication. In addition, clinic vis it PEFR and forced expiratory volume in one second were measured. Safe ty was assessed by recording all adverse events and by performing rout ine biochemistry and haematology screens including plasma cortisol con centration before and after treatment. For the purposes of analysis th e diary card data were grouped into three periods: week 3 (days 15-21) , week 6 (days 36-42), and weeks 1-6 (days 1-42). The results showed n o significant difference between treatments on most efficacy parameter s. However, there were significant differences in changes from baselin e in favour of fluticasone propionate for % predicted morning PEFR bot h at week 3 (fluticasone propionate 6.1%, beclomethasone dipropionate 3.9%) and at week 6 (fluticasone propionate 8-3%, beclomethasone dipro pionate 5.9%) and % predicted evening PEFR at week 6 (fluticasone prop ionate 7.3%, beclomethasone dipropionate 4.9%) and over weeks 1-6 (flu ticasone propionate 5.5%, beclomethasone dipropionate 3.6%). Compariso n between groups showed that the group receiving fluticasone propionat e had a lower % of days with symptom-free exercise at week 6 (fluticas one propionate 87%, beclomethasone dipropionate 81%) and % days withou t rescue medication at week 6 (fluticasone propionate 87%, beclomethas one dipropionate 80%) and over weeks 1-6 (fluticasone propionate 80%, beclomethasone dipropionate 73%). Except for a higher incidence of sor e throat in the fluticasone propionate group, the two treatments did n ot differ with regard to safety. There was no evidence of adrenal supp ression with either treatment. In conclusion, fluticasone propionate 2 00 mug daily was at least as effective and as well tolerated as beclom ethasone dipropionate 400 mug daily in childhood asthma.