Efficacy and tolerability of beclomethasone dipropionate delivered by a novel multidose dry powder inhaler (Clickhaler®) versus a metered-dose inhaler in children with asthma

Background: Dry powder inhalers (DPls) overcome the problem of actuation-breath coordination experienced by many children who use metered-dose inhalers (MDls). To ensure that therapeutic effectiveness is maintained when switching from 1 inhaler type to another, it is necessary to investigate their clinical comparability. Objective: The purpose of this study was to compare the efficacy and tolerability of beclomethasone dipropionate (BDP) delivered from a novel multidose DPI (Clickhaler (R)) versus a conventional MDI plus spacer in children with asthma, and to assess patient acceptability and ease of use of the inhaler devices. Methods: After a 2-week run-in period, children aged 6 to 17 years with mild to moderate asthma were randomly assigned to 4 weeks' treatment with BDP (less than or equal to 400 mug/d), delivered via Clickhaler or MDI plus spacer, in a double-blind, double-dummy, parallel-group, multicenter study. Efficacy was measured primarily by changes from baseline in morning peak expiratory flow (PEF). Secondary measures were changes in evening PEF, daytime and nighttime asthma symptom scores, and clinic lung function. The statistical power to detect a difference in PEF of 20 L/min was 92%. Results: A total of 124 patients were randomized to treatment (61 to DPI and 63 to MDI plus spacer); 110 patients completed the study. There were no significant differences between the treatment groups in any efficacy parameter (P > 0.1). The mean SD difference between treatments in morning PEF was 2.1 +/- 24.2 L/min (95% Cl, -6.9 to 11.10; P = 0.35). A total of 37 patients (30%) experienced 72 adverse events, the majority of which were mild. The most commonly reported adverse events were exacerbated asthma, upper and lower respiratory tract infections, sore throat, and cough. The Clickhaler was preferred to the MDI by 76% of patients. Conclusions: BDP delivered by Clickhaler was a well-tolerated and therapeutically equivalent alternative to BDP delivered by a conventional MDI plus spacer in the short-term treatment of mild to moderate asthma in children. The Clickhaler DPI was well accepted in this population and preferred to the MDI.