Lack of effect of fluticasone propionate aqueous nasal spray on the hypothalamic-pituitary-adrenal axis in 2- and 3-year-old patients.
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 microg/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.
Galant
Stanley P
SP
ClinTrials of Orange County, Orange, California 92868, USA. drgalant@galantandlin.com
Melamed
Isaac R
IR
Nayak
Anjuli S
AS
Blake
Kathryn V
KV
Prillaman
Barbara A
BA
Reed
Kenneth D
KD
Cook
Cindy K
CK
Philpot
Edward E
EE
Rickard
Kathleen A
KA
D000281:Administration, Intranasal; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000378:metabolism / Q000652:urine; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy / Q000652:urine; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy / Q000652:urine
D000730:Androstadienes; D018926:Anti-Allergic Agents; D000068298:Fluticasone; D006854:Hydrocortisone