A total of 1008 patients aged 12 years and older received NASONEX Nasal Spray 50 mcg 200 mcg/day (n=506) or placebo (n=502) for 15 days. Adverse events that occurred more frequently in patients treated with NASONEX Nasal Spray 50 mcg than in patients with the placebo included sinus headache (% in NASONEX Nasal Spray 50 mcg group vs. % in placebo) and epistaxis (1% in NASONEX Nasal Spray 50 mcg group vs. % in placebo) and the overall adverse event profile was similar to that observed in the other allergic rhinitis trials.
It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of mometasone furoate lies in its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate significantly inhibits the release of leukotrienes from leucocytes of allergic patients. In cell culture, mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNFα; it is also a potent inhibitor of leukotriene production. In addition, it is an extremely potent inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.
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