J Clin Pharmacol
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PEDIATRICS

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

Kenneth T. Kim, MD, Henry Milgrom, MD, Y. Kellie Yoon, MD, Arden L. Levy, MD, Paul Matz, MD, Michael J. Welch, MD, Anthony Cahn, MD, David A. Collins, PhD, Steven Kathman, PhD, Rashmi Mehta, PhD, Sheng-Fang Su, PhD and Robert L. Kunka, PhD

From the West Coast Clinical Trials, LLC, Cypress, California (Drs Kim, Yoon); National Jewish Medical and Research Centers, Denver, Colorado (Dr Milgrom); Spartanburg Pharmaceutical Research, Spartanburg, South Carolina (Dr Levy); Medford Medical Clinic, Medford, Oregon (Dr Matz); Allergy and Asthma Medical Group and Research Center, San Diego, California (Dr Welch); GlaxoSmithKline, Greenford, United Kingdom (Dr Cahn); GlaxoSmithKline, Research Triangle Park, North Carolina (Drs Collins, Kathman, Mehta, Kunka); and GlaxoSmithKline, Philadelphia, Pennsylvania (Dr Su). Presented in part at the annual meeting of the American College of Clinical Pharmacology, October 24-27, 2004, Dallas, Texas.

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 µg twice a day or fluticasone propionate chlorofluorocarbon 88 µg twice a day. In study 2, 63 subjects received 13.5 days of placebo followed by 27.5 days of fluticasone propionate hydrofluoroalkane 88 µg twice a day. The main outcome measure for study 1 was the difference between fluticasone propionate hydrofluoroalkane and fluticasone propionate chlorofluorocarbon in fluticasone propionate AUClast (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.

Key Words: Children • asthma • fluticasone • systemic effects • urinary cortisol

Address for reprints: Kenneth T. Kim, MD, West Coast Clinical Trials, LLC, 5630 Cerritos Ave, Cypress, CA 90630.


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