A PLACEBO-CONTROLLED AND ACTIVE-CONTROLLED RANDOMIZED TRIAL OF PROPHYLACTIC TREATMENT OF SEASONAL ALLERGIC RHINITIS WITH MOMETASONE FUROATEAQUEOUS NASAL SPRAY

Background: Topical nasal corticosteroids have become a mainstay of tr eatment for the symptoms of seasonal allergic rhinitis (SAR), it is li kely that topical corticosteroids, by, blocking an initial influx of i nflammatory cells in the nasal mucosa induced by aa aeroallergens, may have a preventive effect on nasal allergy symptoms when administered before the pollen season. Objective: This study was designed to assess the efficacy and safety of an 8-week course of mometasone furoate nas al spray (MFNS), 200 mu g once daily, in the treatment of SAR compared with beclomethasone dipropionate aqueous nasal spray (BDP), 168 mu g twice daily, and placebo vehicle, when treatment is initiated before t he anticipated-onset of the ragweed season. Methods: Three hundred for ty-nine patients with SAR to ragweed pollen from nine centers in the N ortheast and Midwest of the United States were randomized to one of th e three intranasal study medications (MFNS, 200 mu g once daily BDP, 1 68 mu g twice daily or placebo, vehicle), starting 4 week before the e stimated start of the ragweed season. Results: The proportion of ''min imal symptom'' days (total nasal symptom score less than or equal to 2 ) was statistically significantly higher in both the MFNS and BDP grou ps when compared with the placebo vehicle group (p < 0.01). The two ac tive treatment groups were not statistically significantly different f rom each other. MFNS and BDP displayed a similar safety profile that d id nor differ from placebo. Conclusions: This suggests that MFNS, 200 mu g (once daily), is a useful therapy in the prophylactic treatment o f SAR.