Intranasal Triamcinolone and Growth Velocity

Abstract

BACKGROUND: Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR).METHODS: This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 mg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months). Hypothalamus-pituitary-adrenal (HPA) axis function was assessed by measuring urinary cortisol levels. Details of adverse events were recorded.RESULTS: Of 1078 subjects screened, 299 were randomized, and 216 completed the study (placebo, 107; TAA-AQ, 109). In the primary analysis (modified intent-to-treat: placebo, 133; TAA-AQ, 134), least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) versus placebo (6.09 cm/year). The difference (-0.45 cm/year; 95% confidence interval: -0.78 to -0.11; P = .01), although clinically nonsignificant, was evident within 2 months of treatment and stabilized thereafter. At follow-up, the GV approached baseline (6.70 cm/year) in the TAA-AQ group (6.59 cm/year) and decreased slightly in the placebo group (5.89 cm/year vs 6.06 cm/year at baseline). No HPA axis suppression was observed.CONCLUSIONS: By using rigorous Food and Drug Administration-recommended design elements, this study detected a small, statistically significant effect of TAA-AQ on the GV of children with PAR.

Molecular Actions of Glucocorticoids in Cartilage and Bone During Health, Disease, and Steroid Therapy

“…The longitudinal growth of children can be severely affected by regular GC medication, e.g., for juvenile arthritis (340). Additionally, inhaled GCs, despite being considered to act locally due to rapid systemic breakdown, in the case of asthma cause a weak but measurable delay of growth (344). Indirect and direct effects of GCs on the Environmental and physiological stress / Circadian rhythm FIGURE 1.…”

Adrenal suppression from glucocorticoids: preventing an iatrogenic cause of morbidity and mortality in children

“…Studies of the risk of AS related to intranasal corticosteroids alone have had variable results, although use in conjunction with ICS is a risk factor 36–38…”

Advances in Pediatric Pharmacology, Therapeutics, and Toxicology

“…Previous studies have yielded varying results regarding the potential systemic effects of intranasal corticosteroid such as growth retardation. The first randomized controlled trial based on FDA guidelines to assess the long-term effect of intranasal triamcinolone acetonide examined the difference in the growth velocity of children between 3 and 9 years of age who were treated for 12 months [82]. The randomized, double blind, placebo-controlled, parallel-group multicenter study was composed of a 4–6 month screening period followed by a 12 month treatment phase and a 2 month post-treatment follow-up.…”

“…The investigators found that triamcinolone acetonide had a small, statistically significant effect on growth velocity (−0.45 cm/year, 95% CI: −.78—0.11, P=0.01). However, during the follow-up period, the growth velocity in the triamcinolone acetonide increased to approach the baseline growth velocity [82]. …”