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Effect of intranasal triamcinolone acetonide on basal hypothalamic-pituitary-adrenal axis function in children with
George Georges1, Kenneth T Kim, Paul Ratner
1GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
Insights
Triamcinolone acetonide aqueous (TAA-AQ) nasal spray effectively treats allergic rhinitis (AR) symptoms in children. This study found TAA-AQ did not significantly suppress hypothalamic-pituitary-adrenal (HPA) axis function, demonstrating its safety for pediatric AR management.
Area of Science:
- Pediatric Endocrinology
- Allergy and Immunology
- Pharmacology
Background:
- Intranasal corticosteroids are primary treatments for allergic rhinitis (AR).
- Limited data exist on their impact on the basal hypothalamic-pituitary-adrenal (HPA) axis in children.
- Understanding HPA axis function is crucial for pediatric safety assessments of AR medications.
Purpose of the Study:
- To evaluate the effect of a 6-week triamcinolone acetonide aqueous (TAA-AQ) nasal spray on HPA axis function in children with AR.
- To measure 24-hour serum cortisol area under the curve (AUC(0-24h)) as a primary indicator of HPA axis function.
- To assess the safety and efficacy of TAA-AQ in pediatric patients.
Main Methods:
- Phase 4, multicenter, double-blind, placebo-controlled, parallel-group study.
- Randomized children aged 2-11 years with AR to receive TAA-AQ or placebo.
- Assessed 24-hour serum cortisol AUC(0-24h) and total nasal symptom scores (rTNSSs) at baseline and post-treatment.
Main Results:
- The ratio of TAA-AQ to placebo for change in serum cortisol AUC(0-24h) was 0.966 (95% CI, 0.892-1.045), indicating no clinically meaningful suppression.
- TAA-AQ demonstrated a significantly greater reduction in mean rTNSS compared to placebo (p = 0.0007).
- Treatment-emergent adverse events and changes in serum cortisol trough levels were similar between groups.
Conclusions:
- Triamcinolone acetonide aqueous nasal spray is safe and well-tolerated in children with AR.
- TAA-AQ treatment for 6 weeks was not associated with clinically significant suppression of basal HPA axis function.
- TAA-AQ provides effective symptom control for pediatric allergic rhinitis without compromising HPA axis integrity.
Abstract:
Intranasal corticosteroids are the most effective medication class for controlling allergic rhinitis (AR) symptoms. However, limited data are available on their effects on basal hypothalamic-pituitary-adrenal (HPA) axis function in children. This study was designed to determine the effect of 6-week triamcinolone acetonide aqueous (TAA-AQ) nasal spray treatment on HPA axis function by measuring 24-hour serum cortisol area under the curve (AUC(0-24h)) in children with AR aged 2-11 years. This phase 4, multicenter, double-blind, placebo-controlled, parallel-group study randomized children with AR to receive TAA-AQ (110 μg, 2-11 years old, or 220 μg, 6-11 years old) or placebo. At pre- and posttreatment domiciled visits, 24-hour serum cortisol and reflective total nasal symptom scores (rTNSSs) were assessed. Safety assessment included treatment-emergent adverse events (TEAEs) at each visit and trough levels of 24-hour serum cortisol. A total of 140 subjects (mean age, 7.2 years; males, 59%) were randomized; 66 from each group completed treatment. The ratio of TAA-AQ to placebo for change from baseline in serum cortisol AUC(0-24h) was 0.966 (95% confidence interval, 0.892-1.045). Reduction from baseline in mean rTNSS was significantly greater in the TAA-AQ than in the placebo group (difference: least square mean ± SE = -0.85 ± 0.24; p = 0.0007). The safety profile was similar (TEAEs, TAA-AQ, 27.5%; placebo, 25.4%), and so was the mean change in serum cortisol trough level (TAA-AQ, -0.4 μg/dL; placebo, -0.1 μg/dL; p = 0.1818 for treatment difference) from pre- to posttreatment. TAA-AQ was safe, well tolerated, and not associated with clinically meaningful suppression of serum cortisol AUC(0-24h) in children with AR. Clinical trial NCT01154153, www.clinicaltrials.gov.
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