PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY OF THE EFFICACY AND SAFETY OF TRIAMCINOLONE ACETONIDE AEROSOL NASAL INHALER IN PEDIATRIC-PATIENTS WITH SEASONAL ALLERGIC RHINITIS

Triamcinolone acetonide (TAA) aerosol nasal inhaler has been shown to effectively relieve the symptoms of seasonal allergic rhinitis in adul ts and adolescents. We conducted a study to evaluate the efficacy and safety of once-daily administration of TAA aerosol nasal inhaler in pe diatric patients aged 6 to 11 years with grass seasonal allergic rhini tis. This multi-center, randomized, double-blind, placebo-controlled, parallel-group study enrolled 116 children who were treated with eithe r TAA aerosol nasal inhaler (220 mu g/d) or placebo once daily for 2 w eeks. Patients evaluated the severity of rhinitis symptoms (nasal stuf finess, discharge, sneezing, and itching) daily according to a four-po int scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). Patien ts' and physicians' global evaluations of overall treatment efficacy w ere assessed at the end of the 2-week treatment period. Patients treat ed with TAA aerosol nasal inhaler had significantly greater reductions in all nasal symptom scores overall and in virtually all symptoms at the end of week 1 and week 2 compared with those in the placebo group. Both patients' and physicians' global evaluations of efficacy favored TAA aerosol nasal inhaler over placebo. This study demonstrated that once-daily administration of 220 mu g of TAA aerosol nasal inhaler was well tolerated and effectively reduced the symptoms of seasonal aller gic rhinitis in pediatric patients.