AN OPEN STUDY TO ASSESS THE LONG-TERM SAFETY OF FLUTICASONE PROPIONATE IN ASTHMATIC-CHILDREN

This study was conducted to assess the long-term safety of fluticasone propionate 50 mu g twice daily (100 mu g/day) or 100 mu g twice daily (200 mu g/day) administered via a dry powder inhaler in children aged 4-17 years with moderately severe asthma. A total of 257 patients rec eived open treatment for 12 months. Of these, 110 had not received tre atment with fluticasone propionate in any prior study. The remaining 1 47 patients had completed one of two previous short-term inhaled fluti casone propionate studies. In all, 132 patients (51%) reported 273 adv erse events, the pattern of which was as expected in an atopic populat ion with asthma; only 26 (10%) of these reports were considered either certainly, probably or possibly related to study treatment. The event s 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 sympt oms, and they continued in the study. There was a low incidence (2%) o f pharmacologically predictable adverse events. Eight patients (3%) wi thdrew from the study because of an adverse event, five of which event s (one each of hypertension, hoarseness and asthma and two of oral can didiasis) were recorded as being possibly or probably drug-related. Si xteen adverse events reported by 15 patients (6%) were classified as s erious but none was considered to be related to the study drug. Of the se reports 10 (9 patients; 4%) were exacerbations of asthma requiring hospital admission; the other six adverse events were unrelated to ast hma. Fluticasone propionate was thus well tolerated during long-term t reatment in children, and asthma control was maintained over the 12 mo nths.