Nasonex Clinical Trials and Studies
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Nasonex Clinical Trials and Studies
The efficacy and safety of Nasonex Nasal Spray, 50 µg 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 (age 17 to 85) and adolescents (age 12 to 16). 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 µg at doses ranging from 50 to 800 µg/day. The majority of patients were treated with 200 µg/day. These trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing. Patients treated with Nasonex Nasal Spray, 50 µg, 200 µg/day had a significant decrease in total nasal symptom scores compared to placebo-treated patients. No additional benefit was observed for mometasone furoate doses greater than 200 µg/day. A total of 350 patients have been treated with Nasonex Nasal Spray, 50 µg for 1 year or longer.
In patients with seasonal allergic rhinitis, Nasonex Nasal Spray, 50 µg demonstrated improvement in nasal symptoms (vs. placebo) within 2 days after the first dose. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.
Prophylaxis of seasonal allergic rhinitis for patients 12 years of age and older with Nasonex Nasal Spray, 50 µg, given at a dose of 200 µg/day, was evaluated in two clinical studies in 284 patients. These studies were designed such that patients received 4 weeks of prophylaxis with Nasonex Nasal Spray, 50 µg prior to the anticipated onset of the pollen season, how- ever, some patients received only 2 to 3 weeks of prophylaxis. Patients receiving 2 to 4 weeks of prophylaxis with Nasonex Nasal Spray, 50 µg demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients.
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