Switching from conventional to extrafine aerosol beclomethasone dipropionate therapy in children: A 6-month, open-label, randomized trial

Abstract

Background: In adults with asthma, hydrofluoralkane-134a beclomethasone dipropionate (HFA-BDP) extrafine aerosol provides equivalent asthma control at half the daily dose of conventional chlorofluorocarbon (CFC)-BDP. Objective: We sought to compare the efficacy and tolerability of switching from CFC-BDP to HFA-BDP at half the daily dose in children with stable asthma. Methods: This 6-month, open-label, randomized, multicenter study enrolled 520 children aged 5 to 11 years with well-controlled asthma receiving inhaled CFC-BDP or budesonide 200 to 800 μg/d x. (Four hundred fifty-two patients were using doses within the recommended range of 200-400 μg and were analyzed separately.) During a 4-week run-in period, patients used CFC-BDP plus a spacer (CFC-BDP+S) at approximately the same dose as they were using before study entry. Patients were then randomized in a 1:3 ratio to continue on CFC-BDP+S or switch to HFA-BDP Autohaler at half the daily dose. Results: The change from baseline in morning peak expiratory flow was significantly greater in patients receiving 100-200 μg of HFA-BDP compared with those receiving 200-400 μg of CFC-BDP+S at weeks 7 to 8 (8.5 and 0.4 L/min, respectively; P = .014), with continuing improvement in both groups over 6 months (12.2 and 12.4 L/min, respectively, at month 6). There were no significant differences between treatments in mean change from baseline in FEV1, percentage of days or nights without asthma symptoms, and daily β-agonist use over the 6-month treatment period. The proportion of patients who had one or more asthma exacerbations, the incidence of adverse events, and the percentage change from baseline in 24-hour urinary free cortisol levels were similar in the 2 treatment groups. Conclusions: This study confirms that asthma control can be well maintained in children when switching from CFC-BDP+S to an HFA-BDP Autohaler at doses as low as 100 to 200 μg/d. © 2002 Mosby, Inc.