Galant SP, Melamed IR, Nayak AS, et al. Pediatrics. 2003;112:96–100
Purpose of the Study.
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.
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.
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.
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.
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.
At this juncture, FP nasal spray appears to be safe, in terms of HPA axis suppression, among young children.