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| |  Nasonex Does Not Affect Growth In Children With Allergic Rhinitis KENILWORTH, NJ -- February 9, 2000 -- A one-year clinical study published in the on-line medical journal Pediatrics found no evidence of growth suppression in young children using Nasonex(R) (mometasone furoate monohydrate) Nasal Spray 50 mcg* to treat the nasal symptoms of perennial allergic rhinitis.
In the study, average standing heights and growth rates in children ages three to nine years who received Nasonex Nasal Spray for one year were similar to those given a placebo (non-medicated nasal spray). Nasonex is the first and only nasally inhaled corticosteroid indicated for treating the nasal symptoms of seasonal and perennial allergic rhinitis in children as young as 3 years of age. "The study results confirm that Nasonex can help children as young as 3 years of age get the safe and effective relief they need from their nasal allergy symptoms," said Eric J. Schenkel, M.D., director of the Valley Clinical Research Center in Easton, Pa., and lead investigator of the study. The Phase III randomized, double-blind, placebo-controlled multicenter study involved 98 children ages three to nine years with perennial allergic rhinitis. Forty-nine patients were treated with 100 micrograms of Nasonex (one spray per nostril) daily and 49 patients were treated with placebo. The standing height of each child was measured using a stadiometer, an accurate measure of height, at the beginning of the trial and during specific time intervals throughout the one-year study. "The absence of an effect on growth after one year of treatment with Nasonex , as seen in this study, is especially important for young children suffering from perennial allergic rhinitis who often need chronic treatment, "Schenkel added. "Many times, these children also are suffering from other allergic disorders, such as asthma, and are taking multiple treatments that place them at increased risk for systemic side effects, including growth suppression. Treating physicians must therefore carefully consider the safety profile of each medication and select ones that have minimal adverse effects." Controlled clinical studies have shown intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving ntranasal corticosteroids, including Nasonex, should be monitored routinely (eg, via stadiometry). The potential of Nasonex to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. The incidence of treatment-related adverse events were similar for both placebo and Nasonex groups in this study. In other clinical trials using the recommended dose of Nasonex, the overall incidence of adverse events was comparable to placebo and included headache, viral infection, pharyngitis, epistaxis/blood-tinged mucus, and coughing. * Calculated on the anhydrous basis. Related Link: Nasonex (mometasone furoate monohydrate).
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