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Mometasone furoate nasal spray, 50 mcg, at all three doses (50, 100, and 200 mcg/ day), was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion compared to placebo. All patients had a normal response to Cortrosyn. In the third study, adrenal function before and after up to 42 consecutive days of once-daily treatment was assessed in 52 patients with allergic rhinitis (ages 2 to 5 years), 28 of whom received mometasone furoate nasal spray, 50 mcg per nostril (total daily dose 100 mcg), by measuring morning plasma cortisol and 24-hour urinary-free cortisol levels. Mometasone furoate nasal spray was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary-free cortisol levels com-pared to placebo. Clinical Studies The efficacy and safety of NASONEX Nasal Spray, 50 mcg in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis have been evaluated in 18 controlled trials, and one uncontrolled clinical trial, in approximately 3000 adults (ages 17 to 85 years) and adolescents (ages 12 to 16 years). This included 1757 males and 1453 females, including a total of 283 adolescents (182 boys and 101 girls) with seasonal allergic or perennial allergic rhinitis, treated with NASONEX Nasal Spray, 50 mcg at doses ranging from 50 to 800 mcg/ day. majority of patients were treated with 200 mcg/ day. These trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing. Text Continues Below
Patients treated with NASONEX Nasal Spray, 50 mcg, 200 mcg/ day had a significant decrease in total nasal symptom scores compared to placebo-treated patients.No addi-tional benefit was observed for mometasone furoate doses greater than 200 mcg/ day. A total of 350 patients have been treated with NASONEX Nasal Spray,50 mcg for 1 year or longer. The efficacy and safety of NASONEX Nasal Spray, 50 mcg in the treatment of sea-sonal allergic and perennial allergic rhinitis in pediatric patients (ages 3 to 11 years) have been evaluated in four controlled trials.This included approximately 990 pediatric patients ages 3 to 11 years (606 males and 384 females) with seasonal allergic or perennial allergic rhinitis treated with mometasone furoate nasal spray at doses rang-ing from 25 to 200 mcg/ day. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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