A COMPARATIVE-STUDY OF THE EFFICACY OF BECLOMETHASONE DIPROPIONATE DELIVERED FROM A BREATH ACTIVATED AND CONVENTIONAL METERED-DOSE INHALER IN ASTHMATIC-PATIENTS

In order to overcome the problem of poor co-ordination with the use of the conventional press and breathe metered dose inhaler, a breath-act ivated inhaler (Autohaler' inhalation device) has been developed The c linical response to equal doses of beclomethasone dipropionate adminis tered from the Autohaler' device and the conventional metered dose inh aler was compared in 36 stable asthmatic patients receiving regular in haled beclomethasone dipropionate. The study was performed using a dou ble-blind, double-dummy crossover design. Each treatment was given for 4 weeks. Objective and subjective measures of asthma severity were co mpared in the second 14 days of each treatment period, with clinical e quivalence defined as a difference of 20% or less in the adjusted mean values for the 30 patients with data from both treatment periods. Equ ivalence at the +/-5% level was found in the objective measures of pre -bronchodilator FEV1 (p less-than-or-equal-to 0.001); post-bronchodila tor FEV1 (p<0.001); morning and evening peak expiratory flow rate (bot h p less-than-or-equal-to 0.001). Patient diary cards established ther e was equivalent usage of inhaled bronchodilator, and equivalent sympt om scores for daytime disability and daytime and night-time breathless ness. The results show that, in stable asthmatics, treatment with becl omethasone dipropionate is clinically equivalent when delivered by the Autohaler' device or the conventional metered dose inhaler used effic iently.