Efficacy and long-term safety of mometasone furoate nasal spray in children with perennial allergic rhinitis

Current Medical Research and Opinion
C E Baena-Cagnani, Piyush Patel

Abstract

Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and reduces quality of life. This study evaluated efficacy and long-term safety of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in children with PAR. This study comprised a double-blind, 4-week efficacy and safety period followed by a 6-month, open-label safety period. Primary efficacy variable during the double-blind period was mean change in physician-evaluated total nasal symptom score (TNSS) from baseline to day 15. Other efficacy variables during this phase included subject-evaluated TNSS, individual nasal symptoms, and total symptom score (TSS, nasal and non-nasal symptoms, summed). Physician-evaluated improvement in overall condition of PAR was assessed during the open-label period. Adverse events (AEs) were monitored throughout. Subjects aged 3-11 years with PAR (n = 381) were randomized to MFNS 100 microg (n = 190) or placebo (n = 191) daily for 4 weeks; 357 subjects continued into the open-label period, receiving MFNS only. Between baseline and day 15, significantly greater mean changes were seen with MFNS-treated ...Continue Reading

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Apr 13, 2012·Journal of Environmental and Public Health·Diego Saporta
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