Skoner DP, Gentile D, Banerji D, et al. Ann Allergy Asthma Immunol. 2003;90:56–64
Purpose of the Study.
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 among pediatric subjects.
The subjects were 59 children (4–10.5 years of age) who were within normal limits for height and had a ≥1-year history of allergic rhinitis that required treatment and positive prick skin test responses to an inhalant allergen. Patients who had used corticosteroids in the previous 60 days were excluded from the study.
The study was a randomized, 4-way, crossover trial comparing 2 doses of TAA nasal spray, 1 dose of FP nasal spray, and placebo among pediatric patients with perennial allergic rhinitis. The study was conducted from October 1998 through September 1999, at Children’s Hospital of Pittsburgh (Pittsburgh, PA). After a 2-week baseline period, subjects entered 4 treatment periods, each lasting 2 weeks, with a 2-week washout period between treatments. Lower-leg growth velocity was measured knemometrically. HPA axis function was assessed by measuring 12-hour (overnight) urine samples for cortisol/creatinine ratios. Three clinic visits occurred during each treatment period.
Of the 59 subjects, 49 completed the study in all 4 treatment periods. Four subjects discontinued participation because of adverse events (110-μg TAA group: broken foot, nasal burning sensation, asthma exacerbation; placebo group: asthma exacerbation), 3 were lost to follow-up monitoring, 1 withdrew consent, and 2 were noncompliant. In terms of lower-leg growth velocity, no differences were found between either dose of TAA and FP or between the treatment group and the placebo group. In terms of HPA axis function, the urinary cortisol/creatinine ratios from the beginning to the end of the 2-week treatment period did not differ significantly between the TAA doses and placebo; however, the mean value for the FP group was lower than those seen for other treatment groups (statistically significant). Because the coefficient of variation for the cortisol measurements was quite high, the clinical relevance of this finding is unclear.
This study showed that daily use of nasal sprays with TAA at 110 μg, TAA at 220 μg, or FP at 200 μg did not produce any clinically meaningful effects on lower-leg growth velocity during the 2 weeks of treatment. FP was shown to produce a statistically significant level of HPA axis suppression, compared with placebo; however, the clinical relevance of this finding is unclear.
Many pediatricians and parents have concerns regarding the effects of corticosteroid use, whether for treatment of allergic rhinitis (as a nasal spray) or for treatment of asthma, on the growth and HPA axis function of children. This study provides additional reassurance that short-term use of nasal corticosteroid sprays at standard doses does not affect growth or the HPA axis.