Nasacort Clinical Trials and Studies
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Nasacort Clinical Trials and Studies
Nasacort Nasal Inhaler In double-blind, parallel, placebo-controlled clinical trials of seasonal and perennial allergic rhinitis, in adults and adolescentes in fixed total daily doses of 110, 220 and 440 mcg per day, the responses to aerosolized triamcinolone acetonide demonstrated a statistically significant improvement over placebo. In open label trials where the doses were sometimes adjusted according to patients' signs and symptoms, the daily doses and regimens varied. The most commonly used dose was 110 mcg per day.
The Nasacort Nasal Inhaler, at a dose of 220 mcg once daily, has also been studied in two double blind placebo controlled trials of two and four weeks duration in children ages 6 through 11 years with seasonal and perennial allergic rhinitis. These trials included 162 males and 91 females. The nasal inhaler, administered at a fixed dose of 220 mcg once daily resulted in consistent and statistically significant reductions of allergic rhinitis symptoms over vehicle placebo.
In attempting to determine if systemic absorption played a role in the response to Nasacort, a clinical study comparing intranasal and depot intramuscular triamcinolone acetonide was conducted. The doses used were based on bioavailability studies of each formulation. The final doses of Nasacort (triamcinolone acetonide) 440 mcg once a day and Kenalog-40, 4 mg intramuscularly once a week, were chosen to deliver comparable total amounts of weekly triamcinolone acetonide. However, the weekly injection yielded sustained plasma levels throughout the dosing interval while the daily triamcinolone acetonide application resulted in daily peak and trough concentrations, the mean of which was 3.5 times below the Kenalog plasma levels. Both topical triamcinolone acetonide and intramuscular Kenalog-40 were clinically effective. In addition, in some studies there was evidence of improvement of eye symptoms. This suggests that triamcinolone acetonide, at least to some degree is acting by a systemic mechanism.
In order to evaluate the effects of systemic absorption on the Hypothalamic-Pituitary-Adrenal (HPA) axis, triamcinolone acetonide to adults in doses of 440 mcg once a day was compared to placebo and 42 days of a single morning dose of prednisone 10 mg. Adrenal response to a six-hour cosyntropin stimulation test suggests that intranasal triamcinolone acetonide 440 mcg/day for six weeks did not measurably affect adrenal activity. Conversely, oral prednisone at 10 mg/day significantly reduced the response to ACTH.
No evidence of adrenal axis suppression was observed in 26 pediatric patients exposed for 6 weeks to systemic levels of triamcinolone acetonide higher than the systemic levels observed following administration of the maximum recommended dose of triamcinolone acetonide nasal inhaler.
AQ Nasacort Nasal Spray: The safety and efficacy of triamcinolone acetonide AQ nasal spray has been evaluated in 10 double-blind, placebo-controlled clinical trials of two to four weeks in duration in adults and children 12 years and older with seasonal or perennial allergic rhinitis. The number of patients treated with the AQ nasal spray in these studies was 1266; of these patients, 675 were male and 591 were female.
Overall, the results of these Nasacort clinical trials showed that triamcinolone acetonide AQ nasal spray 220 mcg once daily (2 sprays in each nostril) when compared to placebo provides statistically significant relief of nasal symptoms including sneezing, stuffiness, discharge, and itching.
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