6-WEEK TRIAL OF NEBULIZED FLUNISOLIDE NASAL SPRAY - EFFICACY IN YOUNG-CHILDREN WITH MODERATELY SEVERE ASTHMA

This study evaluated the clinical efficacy of nebulized flunisolide na sal solution (Nasalide(R)) in young children with moderately severe as thma. Twenty-two asthmatic children, ages 12-72 months, completed this double-blind placebo-controlled study. After a 6-week observation per iod, 18 patients were paired according to asthma severity. One child f rom each pair was randomized to flunisolide, the other to placebo; 4 p atients were independently randomized. Placebo or drug was then admini stered for 6 weeks. Throughout the study, symptoms, drug usage, and an alog scales reflecting asthma severity and family disruption were reco rded in a diary. Multiple regression analysis was used to compare the flunisolide and placebo groups in regard to the amount of improvement demonstrated from the observation to the active periods of the study. Analog scores of asthma severity and family disruption, albuterol aero sol use, and systemic corticosteroid use fell roughly 40% from baselin e in the flunisolide group. This improvement was significant compared to the placebo group. We conclude that 1 ml (250 mu g) of nebulized fl unisolide nasal spray solution, administered three times daily, reduce d the severity of asthma symptoms, and the need for both albuterol aer osol and systemic corticosteroid therapy in young children with modera tely severe asthma during a 6-week trial. Longer term studies are warr anted. (C) 1997 Wiley-Liss, Inc.