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| |  Ciclesonide Nasal Spray Safe and Effective for Long-Term Treatment of Perennial Allergic Rhinitis in Adolescents: Presented at AAAAI By Maggie Schwarz WASHINGTON, DC -- March 19, 2009 -- Ciclesonide nasal spray demonstrated improvement in health-related quality of life and limited potential for systemic side effects in adolescents with perennial allergic rhinitis (PAR), according to results of a post hoc analysis presented here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Bruce M. Prenner, MD, Allergy Associates Medical Group Inc, San Diego, California, and colleagues examined the long-term safety and efficacy of ciclesonide nasal spray in adolescents with PAR in a subgroup analysis. They presented their results on March 15. Ciclesonide is an aqueous, hypotonic, intranasal corticosteroid indicated for seasonal rhinitis in children aged 6 years and more and for perennial rhinitis in those aged 12 years and more. For this post hoc analysis, Dr. Prenner and colleagues collected data as part of a phase 3, randomised, multicentre, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with PAR. At randomisation, 78 patients with a mean age of 14.9 years were randomised to receive ciclesonide 200 mcg once daily at 2 actuations per nostril, 50 mcg per actuation in the morning (n = 52) or placebo (n = 26). The proportion of treatment-emergent adverse events was comparable between groups (59.0% with at least 1 adverse event). The most frequently reported adverse event was upper respiratory tract infection (ciclesonide, 15.4%; placebo, 23.0%). Epistaxis was reported infrequently (ciclesonide, 3.8%; placebo, 7.7%). No clinically relevant changes in cortisol or ocular safety were noted for either group. Changes in 24-hour reflective total nasal symptom scores changed significantly compared with baseline with ciclesonide (-2.0, P < .001) and placebo (-1.3, P < .004); the treatment difference was 0.7 (P = .085). Ciclesonide improved the Rhinoconjunctivitis Quality of Life Questionnaire score versus baseline (ciclesonide, -0.7; P < .001), while the difference for placebo versus baseline was -0.5 (P < .040); the treatment difference was 0.2 (P = .354). Dr. Prenner concluded that ciclesonide 200 mcg was safe and effective in adolescents for long-term treatment of PAR. There were no clinically relevant changes in safety measures, suggesting a limited potential for systemic adverse effects. PAR symptom improvements were associated with health-related quality-of-life improvements compared with baseline, the researchers said. Dr. Prenner noted that in the present subgroup of 78 adolescents, statistically significant differences in efficacy parameters versus placebo were not demonstrable because of the limited number of patients. In his team's larger, phase 3 trial, which included 441 patients ranging from 12 to 65 years of age, the reduction in 24-hour reflective total nasal symptom score was significant over a 1-year period (P < .001). Funding for this study was provided by Nycomed US and Sepracor Inc.
[Presentation title: Long-Term Safety and Efficacy of Ciclesonide Nasal Spray in Adolescents With Perennial Allergic Rhinitis. Abstract 502]
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