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J Clin Pharmacol ; 48(1): 108-16, 2008 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-18094223

RESUMEN

The systemic exposure of fluticasone propionate with hydrofluoroalkane propellant compared with chlorofluoro-carbon propellant and the effect of fluticasone propionate hydrofluoroalkane on 24-hour urinary cortisol in children aged 4 to 11 years with asthma were evaluated. Study 1 was an open-label, 2-way crossover study in which 16 subjects were randomized to 7.5 days each of fluticasone propionate hydrofluoroalkane 88 mug twice a day or fluticasone propionate chlorofluorocarbon 88 mug twice a day. In study 2, 63 subjects received 13.5 days of placebo followed by 27.5 days of fluticasone propionate hydrofluoroalkane 88 mug twice a day. The main outcome measure for study 1 was the difference between fluticasone propionate hydrofluoroalkane and fluticasone propionate chlorofluorocarbon in fluticasone propionate AUC(last) (area under the plasma fluticasone propionate concentration-time curve from zero up to the last quantifiable plasma concentration), and for study 2, 24-hour overnight urinary cortisol excretion. In study 1, fluticasone propionate systemic exposure was significantly lower (55%) with hydrofluoroalkane metered dose inhaler compared with chlorofluorocarbon metered dose inhaler. Study 2 showed no statistically significant changes in 24-hour overnight urinary cortisol excretion and no relationship to fluticasone propionate systemic exposure at this dose. The results of these 2 studies showed that in children aged 4 to 11 years with asthma, fluticasone propionate hydrofluoroalkane has lower systemic exposure compared with chlorofluorocarbon and no hypothalamic-pituitary-adrenal axis effects as measured by 24-hour urinary cortisol excretion.


Asunto(s)
Androstadienos/uso terapéutico , Asma/tratamiento farmacológico , Hidrocarburos Fluorados/química , Hidrocortisona/orina , Administración por Inhalación , Propelentes de Aerosoles/química , Androstadienos/sangre , Androstadienos/farmacocinética , Antiasmáticos/administración & dosificación , Antiasmáticos/efectos adversos , Antiasmáticos/química , Área Bajo la Curva , Asma/metabolismo , Niño , Preescolar , Clorofluorocarburos/química , Tos/inducido químicamente , Estudios Cruzados , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Fiebre/inducido químicamente , Fluticasona , Semivida , Cefalea/inducido químicamente , Humanos , Hidrocortisona/análogos & derivados , Masculino , Inhaladores de Dosis Medida , Náusea/inducido químicamente , Infecciones del Sistema Respiratorio/inducido químicamente
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