Mometasone Furoate Nasal Spray Improves Nasal and Ocular Symptoms of Seasonal Allergic Rhinitis in Adolescent Patients

Abstract

Symptoms of Seasonal Allergic Rhinitis in Adolescent Patients R. Anolik, D. Pearlman, M. Danzig, D. Gates; Allergy & Asthma Specialists, PC, Blue Bell, PA, Colorado Allergy and Asthma Centers, PC, Denver, CO, Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: In a population of adolescents, a demographic with a high incidence of seasonal allergic rhinitis (SAR), data for mometasone furoate nasal spray (MFNS) was examined. METHODS: Data from patients aged 12 to 17 years with symptomatic SAR enrolled in a phase III study were analyzed. These patients, who were part of a larger trial, were randomized to treatment with MFNS 200 mcg qd (n586) or placebo (n582) for 15 days. Symptom severity scores (05none; 35severe) were recorded in patient diaries twice daily. Endpoints included changes from baseline in total nasal symptom score (TNSS), as well as individual symptom scores and total ocular sign/symptom scores (TOSS). The endpoints were the same as those for the total study population. RESULTS: Over the 15 days of treatment, a significantly greater decrease from baseline in mean TNSS was observed with MFNS (-2.47; 28.8% decrease) compared with placebo (-0.9; 9.6% decrease) (P<0.001). In addition, MFNS demonstrated statistically significant improvements over placebo for each full day of the treatment period. Over the 15 days, improvements were seen with MFNS for each individual symptom: congestion (-0.66 vs -0.16; P<0.001); rhinorrhea (-0.63 vs -0.19; P<0.001); sneezing (-0.66 vs -0.26; P<0.001); and nasal itching (-0.52 vs -0.28; P50.03). The MFNS group demonstrated greater improvement in mean TOSS compared with the placebo group (-1.31 vs -0.55; P50.011). No serious adverse events were reported. CONCLUSIONS: In adolescents with symptomatic SAR, MFNS 200 mcg qd was shown to provide significant improvement in nasal and ocular J ALLERGY CLIN IMMUNOL VOLUME 119, NUMBER 1 Abstracts S61