The effects of triamcinolone acetonide aqueous nasal spray on adrenocortical function in children with allergic rhinitis

• Published in: Journal of allergy and clinical immunology Vol. 101; no. 2; pp. 157 - 162
• Main Authors: Nayak, Anjuli S., Ellis, Mark H., Gross, Gary N., Mendelson, Louis M., Schenkel, Eric J., Lanier, Bobby Q., Simpson, Brandon, Mullin, Mary Ellen, Smith, Joseph A.
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01-02-1998; Elsevier
• Subjects: Administration, Inhalation; Adrenal Cortex - drug effects; Adrenal Cortex - physiopathology; adrenocortical function; allergic rhinitis; aqueous nasal spray; Biological and medical sciences; Child; clinical trial; corticosteroids; Double-Blind Method; Female; Glucocorticoids - adverse effects; Glucocorticoids - pharmacokinetics; Glucocorticoids - therapeutic use; hay fever; Histamine and antagonists. Allergy; Humans; Male; Medical sciences; pediatric; pharmacokinetics; Pharmacology. Drug treatments; Placebos; Rhinitis, Allergic, Perennial - drug therapy; Rhinitis, Allergic, Perennial - physiopathology; Rhinitis, Allergic, Seasonal - drug therapy; Rhinitis, Allergic, Seasonal - physiopathology; Triamcinolone acetonide; Triamcinolone Acetonide - adverse effects; Triamcinolone Acetonide - pharmacokinetics; Triamcinolone Acetonide - therapeutic use; Water - chemistry; clinical trial; PAR; adrenocortical function; aqueous nasal spray; AE; SAR; pediatric; corticosteroids; TAA; pharmacokinetics; allergic rhinitis; hay fever; Triamcinolone acetonide; Human; Corticosteroid; Immunopathology; Allergy; Nose disease; Rhinitis; Antiinflammatory agent; Adrenal cortex; Exploration; Intranasal administration; Hydrocortisone; Antiallergic; Biological activity; Blood plasma; Assay; Chemotherapy; Treatment; ENT disease; Aqueous solution; Pharmacokinetics; Child
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/S0091-6749(98)70379-3

Background: Suppression of adrenocortical function, a risk associated with oral corticosteroids, is minimized with intranasal corticosteroids. Triamcinolone acetonide (TAA) aqueous nasal spray, at therapeutic doses, has no measurable effect on adrenocortical function in adults with allergic rhinitis.
Objective: This double-blind, placebo-controlled study compared the effect of once-daily TAA aqueous nasal spray (220 or 440 μg) with placebo on adrenocortical function after 6 weeks of treatment in pediatric (children 6 to 12 years of age) patients with allergic rhinitis. The pharmacokinetic profile of TAA was examined after once-daily intranasal administration of TAA aqueous nasal spray 440 μg for 6 weeks.
Methods: Eighty children received TAA aqueous nasal spray 220 μg or 440 μg or placebo for 6 weeks. Adrenocortical function was assessed by analyzing plasma cortisol levels before stimulation (0 hour) and at 30 and 60 minutes after a rapid 1-hour intravenous cosyntropin stimulation test performed before treatment and after 6 weeks of treatment. Samples for pharmacokinetic evaluation were collected from 19 patients at baseline (0 hour) and at 0.5, 1, 1.5, and 6 hours after the final dose of study medication.
Results: After 6 weeks, no significant effects on adrenocortical function were observed at 30 or 60 minutes after cosyntropin stimulation with either dose of TAA aqueous nasal spray. TAA concentrations in plasma showed rapid elimination of the drug, with little or no accumulation.
Conclusions: TAA aqueous nasal spray (220 or 440 μg/day) has no measurable effect on adrenocortical function in pediatric patients with allergic rhinitis. Pharmacokinetic parameters after 440 μg/day of TAA aqueous nasal spray indicate a rapid decline of plasma drug levels, with little or no systemic accumulation of study drug. (J Allergy Clin Immunol 1998;101:157-62.)