A 26-week, Open-label Extension Study Evaluating The Long-term Safety And Tolerability Of Ciclesonide Hydrofluoroalkane Nasal Aerosol In Patients With Perennial Allergic Rhinitis

Assessment of the long-term effects of intranasal corticosteroids is important for their safe and effective use. The objective of this study was to evaluate the long-term safety and tolerability of hydrofluoroalkane nasal aerosol formulation of ciclesonide (CIC-HFA) which is in clinical development, following 26 weeks of treatment. Patients ≥12 years of age with a ≥2 year history of perennial allergic rhinitis (PAR) who had completed a 26-week efficacy and safety study of treatment with CIC-HFA 74 μg, CIC-HFA 148 μg, or placebo were eligible. In this open-label, multi-center, long-term extension study, patients received CIC-HFA 148 μg (N=824) QD AM for an additional 26 weeks. Safety assessments were patient-reported adverse events (AEs), and specific nasal AEs on examination including epistaxis, nasal ulcerations and nasal septal perforations during the 26-week treatment period. Efficacy assessments were change from baseline in morning reflective and instantaneous total nasal symptom score (AM rTNSS & AM iTNSS) at the end of the 26-week treatment period. A total of 431 (52.3%) patients reported AEs (≥2% of patients reporting any AE)). The most common AE was upper respiratory tract infection, (N=61, 7.4%).Specific nasal AEs were epistaxis (N=46, 5.6%), nasal septum disorder (N=13, 1.6%), nasal septum ulceration (N=4, 0.5%), and nasal discomfort (N=2, 0.2%). Improvement in AM rTNSS and AM iTNSS from baseline were observed following treatment with CIC-HFA 148 μg dose for 26 weeks. In this study, once-daily treatment with CIC-HFA 148 μg for 26 weeks was well tolerated and showed improvements in the nasal symptoms of PAR.