RT Journal Article
SR Electronic
T1 Pharmacokinetic and pharmacodynamic evaluation after administration of beclomethasone dipropionate and formoterol fumarate as fixed or free metered-dose inhaler combination in adolescent asthma
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P4134
VO 42
IS Suppl 57
A1 Piotr Kuna
A1 Germano Lucci
A1 Mirco Govoni
A1 Roberta Baronio
A1 Elena Carzana
A1 Anja Elgalal
A1 Iwona Stelmach
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P4134.abstract
AB INTRODUCTION: Foster pMDI is a fixed dose combination of beclomethasone dipropionate (BDP) 100µg and formoterol fumarate (FF) 6µg marketed for use in adult asthma with or without a spacer device (AeroChamber PlusTM, AC).OBJECTIVE: To investigate the pharmacokinetic (PK), pharmacodynamic (PD) and safety profile of Foster in asthmatic adolescents with or without AC, in comparison to a free combination of marketed pMDI products: Qvar 100µg for BDP and Atimos 6µg for FF.METHODS: Open label, randomized, three-way crossover study on 30 asthmatic adolescents receiving a single dose of BDP/FF (400µg/24µg) as Foster, Foster+AC or Qvar+Atimos. All assessments were performed over 8h post-dose.RESULTS: Foster with or without AC was equivalent to Qvar+Atimos or Foster alone in terms of systemic exposure (AUC0-t) to B17MP (active metabolite of BDP) and FF; 90% CIs for the geometric means ratio fixed/free were within 0.8-1.25. Dose administration with Foster+AC resulted in slightly higher peak concentrations (Cmax) of B17MP and FF than with Qvar+Atimos or Foster alone. Foster with or without AC showed a similar PD (FEV1, plasma potassium and glucose) and safety profile (pulse rate) in comparison to Qvar+Atimos.CONCLUSIONS: Overall, data show comparable PK, PD and safety profiles of Foster, with or without AC, in comparison to the free combination of marketed BDP+FF in asthmatic adolescents, with only a slight increase in peak plasma concentrations of B17MP and FF when AC is used, in agreement with data already obtained in the adult population.