Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol Provides Long-Term and Sustained 24-Hour Nasal Symptom Relief in Patients with Perennial Allergic Rhinitis

Abstract

Patients with perennial allergic rhinitis (PAR) suffer from nasal symptoms requiring year-round treatment. Symptoms are often most severe in the morning, making 24-hour duration of effect a critical component of once-daily treatments. This study assessed the 24-hour duration of nasal symptom relief following treatment with a nonaqueous, hydrofluoroalkane-propelled aerosol formulation of beclomethasone dipropionate (BDP nasal aerosol). In this double-blind, placebo-controlled study, eligible patients (≥12 years of age) were randomly assigned 4:1 to once-daily treatment with BDP nasal aerosol 320 μg or placebo. The primary efficacy measure was patient-reported 24-hour reflective total nasal symptom score (rTNSS) over the first 30 weeks (previously reported). Weekly averages of patient-reported am instantaneous TNSS (iTNSS) over the entire 52-week treatment period were also assessed and reported here. BDP nasal aerosol resulted in greater improvements in weekly patient-reported am iTNSS compared with placebo from week 1, which were maintained through 52 weeks of treatment. The least-square mean treatment differences from placebo for BDP nasal aerosol ranged from a minimum of –0.60 (P<0.001) at week 1 to a maximum of –1.33 (P=0.005) at week 40, and the effect was maintained to week 52 (–1.15; P=0.019). BDP nasal aerosol was well tolerated during long-term treatment, and the overall safety profile was comparable to that of placebo. The clinically meaningful improvements in morning instantaneous total nasal symptom score reported in this 52-week study support both the 24-hour and long-term sustained efficacy of once-daily BDP nasal aerosol 320 μg for the treatment of PAR.