EXTRAFINE BECLOMETHASONE DIPROPIONATE BREATH‐ACTUATED INHALER (400 μG/DAY) VERSUS BUDESONIDE DRY POWDER INHALER (800 μG/DAY) IN ASTHMA

Abstract

SUMMARYHydrofluoroalkane‐134a beclomethasone dipropionate extrafine aerosol breath‐actuated inhaler (Qvar™ Autohaler™; BDP‐AH) provides an alternative to chlorofluorocarbon metered dose inhalers or dry powder inhalers (DPIs). The aim of this six‐week, open‐label study was to determine whether BDP‐AH demonstrates equivalent asthma control to twice the dose of budesonide (BUD)‐DPI (Pulmicort Turbuhaler®). Adults with symptomatic asthma inadequately controlled on BUD‐DPI 400 μg/day and β‐agonist were enrolled. Patients (n=193) were randomised to receive 400 μg/day BDP‐AH (n=98) (two puffs of 100 μg/actuation inhaler twice daily) or 800 μg/day BUD‐DPI (n=95) (two puffs of 200 μg/actuation inhaler twice daily). Both groups showed a statistically significant change from baseline in morning (a.m.) peak expiratory flow (PEF) at weeks 5–6 (p<0.01), indicating study treatment improved a.m. PEF over prestudy 400 μg/day BUD. Changes from baseline in a.m. PEF at weeks 5–6 were 15.9 l/min for BDP‐AH and 14.2 l/min for BUD‐DPI; the groups were statistically equivalent (90% Cl ‐7.02–10.44; p<‐0.001 [equivalence=within ± 25 l/min]). Other efficacy assessments (evening PEF, FEV1, asthma symptoms, β‐agonist use) confirmed the treatments were clinically 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 treatments were well tolerated.