Once-Daily Treatment With Beclomethasone Dipropionate Nasal Aerosol 320 Mu G Provides 24-Hour Nasal Symptom Relief In Patients With Seasonal Allergic Rhinitis

Symptoms of seasonal allergic rhinitis (SAR) are often most severe during morning hours, making 24-hour duration of effect a critical feature of once-daily medications. This study evaluated the 24-hour nasal symptom relief following once-daily morning dosing with beclomethasone dipropionate (BDP) nasal aerosol in patients with SAR. In this dose-ranging, double-blind, placebo-controlled study, patients with SAR (≥12 years of age) were randomized to placebo (n=124) or BDP nasal aerosol 320 μg/day (n=122), along with 2 lower active doses. Although the primary efficacy end point was change from baseline in the am and pm patient-reported reflective total nasal symptom score over the 2-week treatment period, am patient-reported instantaneous total nasal symptom score (iTNSS) was also evaluated. Symptom relief data for the optimal dose of BDP nasal aerosol (320 μg/day) compared with placebo are reported here. Primary efficacy results indicated that BDP nasal aerosol 320 μg/day is the optimally safe and effective dose for the treatment of SAR in adolescent and adult patients. At week 2, treatment with BDP nasal aerosol 320 μg/day also resulted in greater improvements in am iTNSS (LS mean treatment difference –0.83; 95% CI –1.33, –0.33; P=0.001), as well as in each of the am instantaneous individual nasal symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion; P<0.05 for all), compared with placebo. Safety and tolerability were comparable between the treatments. Once-daily morning treatment with BDP nasal aerosol 320 μg provides 24-hour nasal symptom relief in adolescents and adults with SAR.