Brandon Simpson

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

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 microg) 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 microg for 6 weeks. METHODS Eighty children received TAA aqueous nasal spray 220 microg or 440 microg 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 microg/day) has no measurable effect on adrenocortical function in pediatric patients with allergic rhinitis. Pharmacokinetic parameters after 440 microg/day of TAA aqueous nasal spray indicate a rapid decline of plasma drug levels, with little or no systemic accumulation of study drug.

Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis

BACKGROUND In order to accommodate increasing patient preferences a new aqueous formulation of triamcinolone acetonide nasal spray was developed for the relief of symptoms associated with seasonal and perennial allergic rhinitis. OBJECTIVE This multicenter, randomized, double-blind study was designed to compare the efficacy and safety of once-daily triamcinolone acetonide aqueous nasal spray (220 micrograms/day) with placebo in relieving the symptoms of seasonal allergic rhinitis due to ragweed. METHODS One hundred forty patients received either a once daily 220-microgram dose of triamcinolone acetonide aqueous nasal spray or placebo for 2 weeks. Patients evaluated the severity of seasonal allergic rhinitis symptoms daily for 2 weeks according to a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Physician and patient global evaluations of overall treatment effectiveness were assessed at the end of the treatment period. RESULTS Patients receiving triamcinolone acetonide aqueous nasal spray, 220 micrograms/day, had significantly (P < .05) greater improvements in all rhinitis symptoms at weeks 1 and 2 and overall for the 2-week treatment period compared with the placebo group. A significant (P = .006) improvement in the nasal index occurred as early as 12 hours after the first dose of triamcinolone acetonide aqueous nasal spray. Both patients and physicians reported a greater overall improvement in symptoms for the triamcinolone acetonide aqueous nasal spray group. There were no differences between the two treatment groups in the incidence of adverse events. CONCLUSIONS This study confirmed that a 220-microgram dose of triamcinolone acetonide aqueous nasal spray, administered once daily for 2 weeks, is well tolerated and reduces effectively the severity of symptoms of seasonal allergic rhinitis due to ragweed.

Long-term safety and efficacy of triamcinolone acetonide aqueous nasal spray for the treatment of perennial allergic rhinitis.

This 12-month, multicenter, open-label study to assess the long-term safety and efficacy of triamcinolone acetonide (TAA) aqueous nasal spray for perennial allergic rhinitis (PAR) symptom relief was a continuation of a 4-week, double-blind study. Patients who received TAA Aqueous (220 micrograms/day) during the 4-week, double-blind study continued with the same treatment for the open label study; those randomized to placebo during the 4-week, double-blind study received TAA Aqueous (220 micrograms/day) for the open-label study. Dose reduction to 110 micrograms/day was allowed if it was felt that symptom relief would be maintained. Safety was assessed by daily diary entries and clinical laboratory results. Long-term efficacy was assessed by visual analog scale (VAS). Of the 172 patients who began the open-label study, 94.2 percent completed 3 months of treatment, 83.6 percent completed 6 months, and 62 percent completed 12 months. PAR symptom relief improved progressively throughout the study. Adverse events were generally mild or moderate and consistent with long-term use and winter symptoms. The most common adverse events were pharyngitis (32 percent of patients), rhinitis (28.5 percent), headache (22.1 percent), and epistaxis (18 percent). Adverse events related to the local effects of the study medication were similar to those observed in long-term studies with TAA aerosol. The aqueous nasal spray formulation of triamcinolone acetonide was well tolerated and continued to relieve nasal symptoms with long-term use in adolescent and adult patients with PAR.

Poster 33: Triamcinolone Acetonide Aqueous Nasal Spray does not Alter Adrenocortical Function in Children with Allergic Rhinitis

used as controls. The characteristics of the glycoprotein and the mitotic activity of the olfactory epithelial cells were investigated using eight kinds of lectins and BrdU (50 mg/ kg), which was injected an hour before sacrifice. The results were as follows: 1. In experimental groups the olfactory epithelium showed degenerative changes such as atrophy and squamous metaplasia, which were observed until 2 weeks after the inhalation. 2. The olfactory epithelium started to recover in 3 weeks and showed a similar state compared with the control group in 4 weeks after the inhalation. 3. In the control group, positive reactions appeared in the supporting cells to PNA, SBA, WGA, ECL, and PHA-L; in the olfactory cells to PNA, SBA, WGA, and UEA; and in the proper basal cells to GS-I, SBA, WGA, and PHA-L. In the experimental groups the positive reaction increased in the supporting cells to SBA, ECL, and PHA-L and in Bowmans gland to all used lectins, except ECL and GS-I. 4. The number of BrdU-labeled cells in the olfactory epithelium was 14.83 _+ 1.21/ram in the control group. The mitotic activities were decreased to 4.8 _+ 0.8/mm in 2 weeks and recovered within 3 weeks after the inhalation. 5. The double-labeling immunostaining method was performed with proper basal cell-specific lectins (GS-I or PHAL) and BrdU to find the stem cells of olfactory receptor cells. In BrdU-labeled cells containing positive reactions to these specific lectins, the proper basal cells occupied 18% in control groups and 60.7% in lesioned groups (4 days to 2 weeks after inhalation) and 44.5% in recovery groups (3 to 6 weeks after inhalation). In conclusion, formaldehyde gas inhalation causes atrophy and squamous metaplastic changes of olfactory epithelium and the proper basal cells take charge of more active mitotic activity in the regeneration of the olfactory epithelium rather than globose basal cells after the cytotoxic damage of formaldehyde gas.

Triamcinolone Acetonide Aqueous Nasal Spray (Nasacort Aqueous) Relieves the Symptoms of Seasonal Ragweed Allergic Rhinitis

Triamclnolone Acetonide Aqueous Nasal Spray (Nasacort Aqueous] Relieves the Symptoms of Seasonal Ragweed Allergic Rhinitis GUY A. SETrlPANE, MD (presenter), PHILIP E. KORENBLAT, MD, JOHN WINDER, MD, WILLIAM R. LUMRY, MD, JEAN MURPHREE, MD, VIVIAN B. ALDERFER, PHD, BRANDON SIMPSON, and JOSEPH A. SMITH, MD, Providence, R.I., St. Louis, Mo., Sylvania, Ohio, Dallas and San Antonio, Tex., and Collegeville, Pa.