The effects of intranasal triamcinolone acetonide and intranasal fluticasone propionate on short-term bone growth and HPA axis in children with allergic rhinitis.
OBJECTIVE
The purpose of this study was to evaluate the effects of triamcinolone acetonide (TAA) and fluticasone propionate (FP) aqueous nasal sprays on short-term lower-leg growth velocity and hypothalamic-pituitary-adrenal (HPA-axis function in pediatric subjects.


METHODS
In this controlled, double-blinded (TAA) or single-blinded (FP), four-way crossover trial, 59 subjects (mean age: 7.2 years) were randomized to receive each of four 2-week treatments in random order: TAA nasal spray 110 microg, TAA nasal spray 220 microg, FP nasal spray 200 microg, and placebo, administered by a third party once daily with a 2-week washout period between treatments. Lower-leg growth velocity was measured by knemometry, and HPA-axis function was measured using 12-hour overnight urinary cortisol levels.


RESULTS
Forty-nine subjects completed all four treatments and were included in the analyses. Mean growth velocity (+/- standard error) was 0.46 (+/- 0.06) mm/week for placebo, 0.37 (+/- 0.06) and 0.31 (+/- 0.06) mm/week for TAA nasal spray 110 and 220 microg, respectively, and 0.37 (+/- 0.06) mm/week for FP nasal spray. The treatment effect on mean growth velocity compared with placebo was -19.6% with TAA 110 microg, -32.6% with TAA 220 microg, and -21.7% with FP; none of these effects was considered statistically or clinically significant according to predefined criteria. No significant differences in changes in urine cortisol/creatinine ratios were observed between TAA 110 microg or 220 microg and placebo (4.38, 3.60, and -0.67, respectively, P > or = 0.157). In contrast, the change in mean urine cortisol/creatinine ratio values for FP (-3.59) were significantly lower compared with TAA 220 microg (P = 0.033) and placebo (P = 0.003). Knemometry exhibited less time-dependent variability than overnight urinary cortisol measurements.


CONCLUSIONS
Neither TAA nor FP had a clinically significant effect on lower-leg growth velocity. In contrast to FP, TAA nasal spray did not significantly affect HPA-axis function when used over a 2-week interval.
Skoner
David P
DP
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA. skonerd@chplink.chp.edu
Gentile
Deborah
D
Angelini
Betty
B
Kane
Robert
R
Birdsall
Deborah
D
Banerji
Donald
D
D000281:Administration, Intranasal; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D001846:Bone Development / Q000187:drug effects*; D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D003404:Creatinine / Q000652:urine; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D008297:Male; D015588:Observer Variation; D010414:Pennsylvania; D010913:Pituitary-Adrenal System / Q000187:drug effects*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects
D000730:Androstadienes; D005938:Glucocorticoids; D003404:Creatinine; D000068298:Fluticasone; D014222:Triamcinolone Acetonide; D006854:Hydrocortisone