146 A 6-Week Study of the Efficacy and Safety of Ciclesonide Hydrofluoroalkane Nasal Aerosol in the Relief of Nasal Symptoms of Perennial Allergic Rhinitis

BACKGROUND: Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a potential treatment for allergic rhinitis. The objective of this study was to determine the efficacy and safety of CIC-HFA compared to placebo in subjects with perennial allergic rhinitis (PAR). METHODS: Subjects ≥12 years of age with a ≥2 year history of PAR were randomized in a placebo-controlled, double-blind, parallel group, multicenter study to CIC-HFA 74 μg (N = 298), CIC-HFA 148 μg (N = 505), or placebo (N = 307) QD AM for 26 weeks. Subject-reported change from baseline in the average of AM and PM reflective total nasal symptom score (rTNSS) and instantaneous total nasal symptom score (iTNSS) averaged over the first 6 weeks of treatment period were key endpoints and were calculated as a sum of the 4 individual nasal symptoms of congestion, runny nose, sneezing, and nasal itching each on a scale of 0 (no signs/symptoms evident) to 3 (severe symptoms). Change from baseline in the individual reflective and instantaneous nasal symptom scores over the first 6 weeks of treatment period were also evaluated. Treatment-emergent adverse events (TEAEs) were assessed throughout the study. RESULTS: CIC-HFA 74 μg and CIC-HFA 148 μg doses demonstrated a statistically significant improvement in rTNSS (LS mean change 0.70 & 0.54 respectively, P ≤ 0.001 for both), iTNSS (LS mean change 0.58 & 0.42 respectively, P ≤ 0.05 for both) and improvements in individual reflective and instantaneous nasal symptoms (P ≤ 0.05 for all, unadjusted for multiplicity) at 6 weeks from baseline. The overall incidence of TEAEs was low and comparable between the CIC treatment groups and placebo. The most frequently reported TEAEs (≥2% of subjects in any treatment group) were nausea, headache, sinus headache, cough, upper respiratory tract infection, instillation site discomfort, nasal discomfort, nasopharyngitis, sinusitis, oropharyngeal pain, and epistaxis. CONCLUSIONS: In this study, once-daily treatment with CIC-HFA 74μg or CIC-HFA 148μg demonstrated statistically significant improvements in the nasal symptoms of PAR. Both active treatments were well tolerated.