Extrafine beclomethasone dipropionate breath-actuated inhaler (400 mu g/day) versus budesonide dry powder inhaler (800 mu g/day) in asthma

Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol breath -actuated inhaler (Qvar (TM) Autohaler (TM); BDP-AH) provides an alternativ e to chlorofluorocarbon metered dose inhalers or dry powder inhalers (DPIs) , The aim of this six-week, open-label study was to determine whether BDP-A H demonstrates equivalent asthma control to twice the dose of budesonide (B UD)-DPI (Pulmicort Turbuhaler (R)), Adults with symptomatic asthma inadequa tely controlled on BUD-DPI 400 mug/day and beta -agonist were enrolled. Pat ients (n=193) were randomised to receive 400 mug/day BDP-AH (n=98) (two puf fs of 100 mug/actuation inhaler twice daily) or 800 mug/day BUD-DPI (n=95) (two puffs of 200 mug/actuation inhaler twice daily). Both groups showed a statistically significant change from baseline in morning (a.m.) peak expir atory flow (PEF) at weeks 5-6 (p<0.01), indicating study treatment improved a.m, PEF over prestudy 400 <mu>g/day BUD. Changes from baseline in a.m. PE F at weeks 5-6 were 15.9 l/min for BDP-AH and 14.2 l/min for BUD-DPI; the g roups were statistically equivalent (90% CI -7.02-10.44; p<-0.001 [equivale nce=within <plus/minus> 25 l/min]). Other efficacy assessments (evening PEF , FEV1, asthma symptoms, P-agonist use) confirmed the treatments were clini cally equivalent. Thirty-nine (40%) patients on BDP-AH and 35 (37%) on BUD- DPI experienced at least one adverse event (p=0.767). Four (4%) patients on BDP-AH and 3 (3%) on BUD-DPI reported increased asthma symptoms. BDP-AH at half the daily dose provided equivalent asthma control to BUD-DPI; both tr eatments were well tolerated.