An Open Study to Assess the Long‐term Safety of Fluticasone Propionate in Asthmatic Children

Abstract

SUMMARY This study was conducted to assess the long‐term safety of fluticasone propionate 50 μg twice daily (100 μg/day) or 100 μg twice daily (200 μg/day) administered via a dry powder inhaler in children aged 4–17 years with moderately severe asthma. A total of 257 patients received open treatment for 12 months. Of these, 110 had not received treatment with fluticasone propionate in any prior study. The remaining 147 patients had completed one of two previous short‐term inhaled fluticasone propionate studies. In all, 132 patients (51%) reported 273 adverse events, the pattern of which was as expected in an atopic population with asthma; only 26 (10%) of these reports were considered either certainly, probably or possibly related to study treatment. The events most commonly reported either as a single or multiple diagnosis were: asthma and related events (25%), upper respiratory tract infection (13%), and rhinitis (6%). For most patients who reported a worsening of asthma, additional therapy was all that was required to control symptoms, and they continued in the study. There was a low incidence (2%) of pharmacologically predictable adverse events. Eight patients (3%) withdrew from the study because of an adverse event, five of which events (one each of hypertension, hoarseness and asthma and two of oral candidiasis) were recorded as being possibly or probably drug‐related. Sixteen adverse events reported by 15 patients (6%) were classified as serious but none was considered to be related to the study drug. Of these reports 10 (9 patients; 4%) were exacerbations of asthma requiring hospital admission; the other six adverse events were unrelated to asthma. Fluticasone propionate was thus well tolerated during long‐term treatment in children, and asthma control was maintained over the 12 months.