Efficacy and Safety of Fluticasone Propionate Hydrofluoroalkane Inhalation Aerosol in Four- to Eleven-Year-Old Children with Asthma: A Randomized, Double-Blinded, Placebo-Controlled Study

Levy, Arden; Given, John; Weinstein, Steven F.; Kent, Edward F.; Clements, Diane; Wu, Wei; Cott, Catherine A.; Crim, Courtney

doi:10.1089/pai.2006.19.106

Cited by 4 publications

(2 citation statements)

References 15 publications

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“…Fluticasone propionate HFA is approved in the United States for the treatment of asthma in children 4 years of age and older. A recent trial in children aged 4 to 11 years also demonstrated efficacy of FP HFA 88 μg twice a day over placebo in terms of lung function, albuterol use, and nighttime awakenings 23 . The 2 studies reported here show that FP systemic exposure from FP HFA was significantly lower compared with the FP CFC formulation and that there was no effect from FP HFA on the hypothalamic–pituitary–adrenal axis as measured by 24‐hour urinary cortisol excretion.…”

Section: Resultssupporting

confidence: 55%

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Systemic Exposure and Urinary Cortisol Effects of Fluticasone Propionate Formulated With Hydrofluoroalkane in 4‐ to 11‐Year‐Olds With Asthma

Kim¹,

Milgrom

Yoon³

et al. 2008

The Journal of Clinical Pharma

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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.

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Section: Resultssupporting

confidence: 55%

“…No episodes of candidiasis occurred in this study. This is most likely related to the short study duration, because a recent double‐blind placebo‐controlled study in a similar population reported oral candidiasis in 2 of 160 FP HFA–treated children compared with none of 81 children who received placebo 23 …”

Section: Discussionmentioning

confidence: 99%