Mometasone Furoate Nasal Spray is Rapidly Effective in the Treatment of Seasonal Allergic Rhinitis in an Outdoor (Park), Acute Exposure Setting

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Abstract
The objective of this study was to determine the time to onset of symptom relief following a single dose of mometasone furoate nasal spray (MFNS) in symptomatic patients with seasonal allergic rhinitis (SAR). This was a single-center, placebo-controlled, double-blind, randomized, parallel-group study with a 7-day run-in period followed by a single-dose administration of medication or placebo in an outdoor park setting. The park site provided an acute exposure to seasonal (tree and grass) pollens. Patients remained in the park for approximately 12 hours after dosing, during which time hourly assessments of SAR symptoms were recorded on a diary card. Two hundred thirty-nine patients with symptoms of SAR entered the study. Patients receiving any concurrent medication for treatment of their symptoms were excluded. Patients were randomized in a 1:1 ratio to receive treatment with either a single dose of MFNS (200 g) or matching placebo nasal spray. Outcome measures included an assessment of overall therapeutic response and change from baseline in total nasal plus non-nasal sign/symptom severity score, total nasal sign/symptom severity score, and total non-nasal sign/symptom severity score. Improvement in total nasal symptom scores, total non-nasal symptom scores, and total nasal plus non-nasal symptom scores were greater and more sustained in patients receiving MFNS than in patients receiving placebo. The mean decrease from baseline in total nasal plus non-nasal symptom scores was significantly greater in MFNS-dosed patients than in placebo-dosed patients at 5 hours after dosing (p < 0.01). The mean decrease from baseline in total nasal symptom scores was significantly greater in MFNS-dosed patients than in placebo-dosed patients at 7 hours after dosing (p < 0.01). The between-treatment differences in total nasal plus non-nasal symptom scores and total nasal symptom scores remained significant for all subsequent hourly assessments through 12 hours post-dose. Patient assessments of overall response to therapy at end point were significantly different between treatment groups (p < 0.01) with 60.5% of MFNS-treated patients reporting complete, marked, or moderate relief compared with 46.5% of placebo-treated patients. Mometasone furoate nasal spray produces a statistically significant improvement in nasal symptom scores in patients with SAR by 7 hours after administration of a single 200 g dose (100 g in each nostril).

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