%0 Journal Article
%T Similar Results in Children with Asthma for Steady State Pharmacokinetic Parameters of Ciclesonide Inhaled with or without Spacer
%A H. Boss
%A P. Minic and R. Nave
%J Clinical Medicine Insights: Pediatrics
%D 2012
%I 
%R 10.4137/CMPed.S4311
%X Background: Ciclesonide is an inhaled corticosteroid administered by a metered dose inhaler (MDI) to treat bronchial asthma. After inhalation, the inactive ciclesonide is converted by esterases in the airways to active metabolite desisobutyryl-ciclesonide (des-CIC). Aim: To compare the pharmacokinetic (PK) parameters of des-CIC in children after administration of therapeutic dose of ciclesonide with and without spacer (AeroChamber PlusTM). Methods: Open-label, 3 period, cross over, repeated dose, PK study in 37 children with mild to moderate stable asthma (age: 6每11 y; body weight: 20每53 kg). During each 7-day treatment period, ciclesonide was inhaled once in the morning: A) 160 米g MDI with spacer, B) 80 米g MDI with spacer, and C) 160 米g MDI without spacer. Serum PK parameters of ciclesonide and des-CIC were determined on Day 7 of each period. The primary PK parameters were the AUC 而 and Cmax for des-CIC. Results: Inhaling ciclesonide with spacer led to a dose proportional systemic exposure (AUC 而) of des-CIC (0.316 米g*h/L for 80 米g and 0.663 米g*h/L for 160 米g). The dose-normalized systemic exposure for des-CIC (based on AUC 而) was 27% higher after inhalation of ciclesonide 80 米g or 160 米g with spacer than without spacer; the corresponding Cmax values for des-CIC were, respectively, 63% and 55% higher with spacer. No clinically relevant abnormalities or adverse drug reactions were observed. Conclusions: Inhalation of therapeutic ciclesonide dose with spacer led to a slight increase in the systemic exposure of des-CIC, which does not warrant dose adjustment.
%U http://www.la-press.com/similar-results-in-children-with-asthma-for-steady-state-pharmacokinet-article-a2036