Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Fluticasone Furoate, a Novel Inhaled Corticosteroid, in Children Aged 5-11 Years With Persistent Asthma: A Randomized Trial

This multi-center, randomized, double-blind, placebo-controlled, two-way crossover study characterized the safety, tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate (FF) in children (5-11 years) with persistent asthma. Twenty-seven children received inhaled FF 100 mu g or placebo via the ELLIPTA (TM) dry powder inhaler once daily for 14 days, with a >= 7 day washout period. Adverse events (AEs) were reported by eight (31%) and four (16%) subjects during FF 100 mg and placebo treatment, respectively. Headache was reported by three subjects during FF 100 mu g treatment and by no subjects during placebo treatment, all other AEs were reported by only one subject on either treatment; there were no serious AEs. Following repeat dosing, the arithmetic mean (SD) FF C-max was 26.71 pg/mL (9.16) at 31 minutes post-dose. Arithmetic mean (SD) FF AUC((0-t)) was 121.44 pg h/mL (83.04). Arithmetic mean values for weighted mean (SD) serum cortisol (0-12 hours) on day 14 were 56.49 (16.51) and 67.57 (20.66) ng/mL for FF 100 mu g and placebo, respectively. No clinically significant effect of FF on serum cortisol levels was observed. FF was well tolerated. Pharmacokinetic profiles were well defined and did not differ between age groups in the study population, and no clinically significant suppression of serum cortisol was observed.