154 A 26-Week Study Evaluating the Safety and Efficacy of Ciclesonide Hydrofluoralkane Nasal Aerosol in Subjects With 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 long-term safety and efficacy 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 reflective total nasal symptom score (rTNSS) and instantaneous total nasal symptom score (iTNSS) averaged every 2 weeks over the 26 weeks of the treatment period were secondary endpoints and were calculated as a sum of the individual nasal symptoms of congestion, runny nose, sneezing, and nasal itching. Change from baseline in the individual reflective and instantaneous nasal symptom scores averaged every 2 weeks over the 26 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 improvement in rTNSS (LS mean change 0.65 & 0.52 respectively, P ≤ 0.01 for both), iTNSS (LS mean change 0.51 & 0.42 respectively, P ≤ 0.05 for both), and improvements in the individual reflective and instantaneous nasal symptoms (P ≤ 0.05 for all except instantaneous sneezing for the CIC-HFA 74 μg dose) at 26 weeks from baseline. P-values were unadjusted for multiplicity. The overall incidence of TEAEs was comparable between the CIC-HFA treatment groups and placebo. The most frequently reported TEAEs (≥5% of subjects in any treatment group) were headache, nasopharyngitis, upper respiratory tract infections, viral upper respiratory tract infections, sinusitis, and epistaxis. CONCLUSIONS: In this study, once-daily treatment with CIC-HFA 74 μg or CIC-HFA 148 μg demonstrated improvements in the nasal symptoms of PAR. Both active treatments were well tolerated.