Intranasal triamcinolone and growth velocity

Area of Science:

• Pediatric Endocrinology
• Allergy and Immunology
• Clinical Trial Design

Background:

• US FDA guidelines were issued for clinical trials on intranasal corticosteroids and child growth.
• Previous studies had conflicting results and inadequate designs.
• This study adhered to FDA guidelines to assess triamcinolone acetonide aqueous nasal spray (TAA-AQ) in children with perennial allergic rhinitis (PAR).

Purpose of the Study:

• To evaluate the effect of TAA-AQ on the growth velocity (GV) of children with PAR.
• To assess the safety of TAA-AQ, including hypothalamus-pituitary-adrenal (HPA) axis function.

Main Methods:

• A randomized, double-blind, placebo-controlled, parallel-group, multicenter study.
• 110 μg of TAA-AQ or placebo was administered once daily to children aged 3-9 years with PAR for 12 months.
• Growth velocity was measured using stadiometry at baseline, during treatment, and at follow-up. HPA axis function was assessed via urinary cortisol levels.

Main Results:

• A total of 216 children completed the study.
• The least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) compared to the placebo group (6.09 cm/year), a statistically significant difference (P = .01).
• This reduction was clinically nonsignificant, evident within 2 months, and normalized post-treatment. No HPA axis suppression was observed.

Conclusions:

• This study, using FDA-recommended design, found a small, statistically significant effect of TAA-AQ on children's growth velocity.
• The observed effect on growth was not clinically significant and reversible.
• TAA-AQ did not suppress the HPA axis in children with PAR.