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PEDIATRICS Vol. 114 No. 2 August 2004, pp. 525

SUPPLEMENT ARTICLE

LACK OF EFFECT OF FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY ON THE HYPOTHALAMIC-PITUITARY-ADRENAL AXIS IN 2- AND 3-YEAR-OLD PATIENTS

Christopher Randolph, MD

Waterbury, CT

Galant SP, Melamed IR, Nayak AS, et al. Pediatrics. 2003;112:96–100

	Purpose of the Study.

TOP Purpose of the Study. Study Population. Methods. Results. Conclusions. Reviewer's Comments.

 
To determine the effects of fluticasone propionate (FP) (200 µg daily) on the hypothalamic-pituitary-adrenal (HPA) axis among patients 2 to 3 years of age.

	Study Population.

TOP Purpose of the Study. Study Population. Methods. Results. Conclusions. Reviewer's Comments.

 
Children 2 to 3 years of age who demonstrated positive skin test responses to 1 seasonal allergen and the presence of nasal symptoms for 1 hour daily on most days or the use of rhinitis medication on most days during the relevant allergen exposure season were studied.

	Methods.

TOP Purpose of the Study. Study Population. Methods. Results. Conclusions. Reviewer's Comments.

 
Children were administered FP (200 µg daily) (N = 33) or vehicle placebo (N = 32) for 6 weeks. Twelve-hour urine samples were collected, for determination of urinary cortisol levels, at the end of the 6-week treatment and at baseline. Routine chemical analyses, hematologic assessments, and electrolyte measurements were also performed at screening and at the last treatment visit. The secondary safety measures included the incidence of clinically significant alterations in laboratory test results, in the case of adverse effects.

	Results.

TOP Purpose of the Study. Study Population. Methods. Results. Conclusions. Reviewer's Comments.

 
There were no differences in urinary cortisol levels between the children who received FP and those who received placebo. The most common adverse events reported for either group were cough and fever. Vomiting was observed more frequently for the FP group (18% vs 3%), as was abdominal pain (12% vs 6%) and epistaxis (6% vs 0%). However, there were no statistically significant differences in any of these findings.

	Conclusions.

TOP Purpose of the Study. Study Population. Methods. Results. Conclusions. Reviewer's Comments.

 
FP (200 µg/day) was equivalent to placebo with respect to its effects on HPA axis function, as determined by 12-hour urinary free cortisol levels, among 2- to 3-year-old children. FP was otherwise well tolerated by these 2- to 3-year-old children with allergic rhinitis.

	Reviewer’s Comments.

TOP Purpose of the Study. Study Population. Methods. Results. Conclusions. Reviewer's Comments.

 
At this juncture, FP nasal spray appears to be safe, in terms of HPA axis suppression, among young children.

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PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics

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This Article Extract Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Randolph, C. Search for Related Content PubMed Articles by Randolph, C. Social Bookmarking                         What's this?