TY - JOUR T1 - Dose-proportional lung bioavailability of beclometasone dipropionate and formoterol fumarate across three different dose strenghts of CHF1535 pMDI JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P702 AU - Giorgia Ciurlia AU - Annalisa Piccinno AU - Roberta Baronio AU - Daniela Acerbi Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P702.abstract N2 - INTRODUCTION: Foster® 100/6 pMDI is a well characterized fixed combination of beclomethasone dipropionate (BDP) 100µg and formoterol fumarate (FF) 6µg, licensed for use in adult asthmatic patients. New strenghts (50/6µg and 200/6µg) are investigated to expand the therapeutic opportunity.OBJECTIVE: To assess the proportional lung deposition of the new strenghts of Foster®, when compared to Foster® 100/6µg and the equivalent lung deposition of FF across increasing doses of BDP.METHODS: Open label, randomized, three-way single-dose crossover study in 24 healthy volunteers. Subjects received four inhalations of each strenght corresponding to BDP/FF 200µg/24µg, 400µg/24µg and 800µg/24µg with charcoal block. Pharmacokinetics of BDP/B17MP and FF and cardiovascular effects (heart rate (HR) and blood pressure (BP)) were studied over 12 hours after administration.RESULTS: Lung bioavailability of B17MP was dose proportional within the dose range tested, since the 90% CI for dose-normalised AUC0-t, AUC0-12h, and AUC0-∞ for all the comparisons were within the acceptance interval 80-125%. Bioequivalence of FF can be concluded since the 90% CI for AUC0-t were within the acceptance interval 80-125%, when comparing the 50µg vs. 100µg BDP doses and the 200µg vs. 50µg, but slightly below the lower limit for 100µg vs. 200µg. Calculation of time averaged values for HR and BP indicated similar effects across treatments confirming the bioequivalence of FF.CONCLUSIONS: The lung bioavailability of BDP/B17MP was demonstrated to be proportional across three different strengths while the lung deposition of FF remained unchanged across increasing doses of BDP. ER -