The effects of triamcinolone acetonide aqueous nasal spray on adrenocortical function in children with allergic rhinitis.
BACKGROUND
Suppression of adrenocortical function, a risk associated with oral corticosteroids, is minimized with intranasal corticosteroids. Triamcinolone acetonide (TAA) aqueous nasal spray, at therapeutic doses, has no measurable effect on adrenocortical function in adults with allergic rhinitis.


OBJECTIVE
This double-blind, placebo-controlled study compared the effect of once-daily TAA aqueous nasal spray (220 or 440 microg) with placebo on adrenocortical function after 6 weeks of treatment in pediatric (children 6 to 12 years of age) patients with allergic rhinitis. The pharmacokinetic profile of TAA was examined after once-daily intranasal administration of TAA aqueous nasal spray 440 microg for 6 weeks.


METHODS
Eighty children received TAA aqueous nasal spray 220 microg or 440 microg or placebo for 6 weeks. Adrenocortical function was assessed by analyzing plasma cortisol levels before stimulation (0 hour) and at 30 and 60 minutes after a rapid 1-hour intravenous cosyntropin stimulation test performed before treatment and after 6 weeks of treatment. Samples for pharmacokinetic evaluation were collected from 19 patients at baseline (0 hour) and at 0.5, 1, 1.5, and 6 hours after the final dose of study medication.


RESULTS
After 6 weeks, no significant effects on adrenocortical function were observed at 30 or 60 minutes after cosyntropin stimulation with either dose of TAA aqueous nasal spray. TAA concentrations in plasma showed rapid elimination of the drug, with little or no accumulation.


CONCLUSIONS
TAA aqueous nasal spray (220 or 440 microg/day) has no measurable effect on adrenocortical function in pediatric patients with allergic rhinitis. Pharmacokinetic parameters after 440 microg/day of TAA aqueous nasal spray indicate a rapid decline of plasma drug levels, with little or no systemic accumulation of study drug.
Nayak
A S
AS
Ellis
M H
MH
Gross
G N
GN
Mendelson
L M
LM
Schenkel
E J
EJ
Lanier
B Q
BQ
Simpson
B
B
Mullin
M E
ME
Smith
J A
JA
D000280:Administration, Inhalation; D000302:Adrenal Cortex / Q000187:drug effects* / Q000503:physiopathology*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010919:Placebos; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology*; D014222:Triamcinolone Acetonide / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014867:Water / Q000737:chemistry
D005938:Glucocorticoids; D010919:Placebos; D014867:Water; D014222:Triamcinolone Acetonide