A third study evaluated single, rising doses of NASONEX Nasal Spray, 50 mcg (1000, 2000, and 4000 mcg/day), orally administered mometasone furoate (2000, 4000, and 8000 mcg/day), orally administered dexamethasone (200, 400, and 800 mcg/day), and placebo (administered at the end of each series of doses) in 24 male volunteers (22 to 39 years of age). Dose administrations were separated by at least 72 hours. Determination of serial plasma cortisol levels at 8 AM and for the 24-hour period following each treatment were used to calculate the plasma cortisol area under the curve (AUC 0–24 ). In addition, 24-hour urinary free cortisol levels were collected prior to initial treatment administration and during the period immediately following each dose. No statistically significant decreases in the plasma cortisol AUC, 8 AM cortisol levels, or 24-hour urinary free cortisol levels were observed in volunteers treated with either NASONEX Nasal Spray, 50 mcg or oral mometasone, as compared with placebo treatment. Conversely, nearly all volunteers treated with the three doses of dexamethasone demonstrated abnormal 8 AM cortisol levels (defined as a cortisol level <10 mcg/dL), reduced 24-hour plasma AUC values, and decreased 24-hour urinary free cortisol levels, as compared to placebo treatment.
Seven hundred and twenty (720) patients 3 to 11 years of age with allergic rhinitis were treated with mometasone furoate nasal spray, 50 mcg (100 mcg total daily dose) in controlled clinical trials (see CLINICAL PHARMACOLOGY, Clinical Studies section). Twenty-eight (28) patients 2 to 5 years of age with allergic rhinitis were treated with mometasone furoate nasal spray, 50 mcg (100 mcg total daily dose) in a controlled trial to evaluate safety (see CLINICAL PHARMACOLOGY, Pharmacokinetics section). Safety and effectiveness in children less than 2 years of age with allergic rhinitis and in children less than 18 years of age with nasal polyps have not been established.