Lack of effect of fluticasone propionate aqueous nasal spray on the hypothalamic-pituitary-adrenal axis in 2- and 3-year-old patients.
Pediatrics
; 112(1 Pt 1): 96-100, 2003 Jul.
Article
in En
| MEDLINE
| ID: mdl-12837873
ABSTRACT
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.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Anti-Allergic Agents
/
Hypothalamo-Hypophyseal System
/
Androstadienes
Type of study:
Clinical_trials
Limits:
Child, preschool
/
Female
/
Humans
/
Male
Language:
En
Journal:
Pediatrics
Year:
2003
Document type:
Article
Affiliation country:
United States