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PEDIATRICS Vol. 112 No. 1 July 2003, pp. 96-100

Lack of Effect of Fluticasone Propionate Aqueous Nasal Spray on the Hypothalamic-Pituitary-Adrenal Axis in 2- and 3-Year-Old Patients

Stanley P. Galant, MD*, Isaac R. Melamed, MD{ddagger}, Anjuli S. Nayak, MD§, Kathryn V. Blake, PharmD, Barbara A. Prillaman, MS||, Kenneth D. Reed, BS||, Cindy K. Cook, MS||, Edward E. Philpot, MD|| and Kathleen A. Rickard, MD||

* ClinTrials of Orange County, Orange, California
{ddagger} Child First Pediatrics, Englewood, Colorado
§ Allergy & Clinical Immunology Associates, Pittsburgh, Pennsylvania
Nemours Children’s Clinic, Jacksonville, Florida
|| GlaxoSmithKline, Research Triangle Park, North Carolina

Objective. Fluticasone propionate aqueous nasal spray (FP) at the highest recommended doses does not affect hypothalamic-pituitary-adrenal (HPA) axis function in adults or older children, but its potential effects in children younger than 4 years have not been previously studied. This randomized, double-blind, placebo-controlled study evaluated the effects of FP on HPA axis function measured by 12-hour urinary-free cortisol levels in children 2 to 3 years of age.

Methods. Patients ages 2 to 3 years with symptoms of allergic rhinitis were administered FP 200 µg/day (FP200 QD) or vehicle placebo for 6 weeks.

Results. The FP200 QD group (n = 33) was equivalent to the placebo group (n = 32) in mean change from baseline in the primary safety measure of 12-hour creatinine-corrected urinary-free cortisol concentration (geometric mean difference [standard error; SE] for placebo—FP200 QD = 0.96 [1.20]; 95% confidence interval 0.66, 1.39) at the end of the treatment period. The adjusted geometric mean change from baseline value was 0.98 for FP200 QD (SE = 1.14) and 0.94 for placebo (SE = 1.15); a value of 1.0 reflects no change from baseline. Cough and fever were the most common adverse events reported in either group.

Conclusions. FP200 QD was equivalent to placebo with respect to effects on HPA axis function measured by 12-hour urinary-free cortisol in 2- and 3-year-old patients. FP200 QD was well-tolerated in these very young children with allergic rhinitis.

Key Words: FP200 QD nasal spray • HPA axis • children <4 years old • allergic rhinitis

Abbreviations: HPA, hypothalamic-pituitary-adrenal • FP, fluticasone propionate aqueous nasal spray • FP200 QD, fluticasone propionate aqueous nasal spray 200 µg/day • SD, standard deviation • SE, standard error

Received for publication May 30, 2002; Accepted Nov 7, 2002.




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P3Rs:

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Safety of Fluticasone Propionate Nasal Spray in Children
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Pediatrics Online, 24 Nov 2003 [Full text]
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Pediatrics Online, 10 Dec 2003 [Full text]