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Title: Nasal Aerosol Ciclesonide Reduces Symptoms of Seasonal Allergic Rhinitis: Presented at AAAAI

"Nasal Aerosol Ciclesonide Reduces Symptoms of Seasonal Allergic Rhinitis: Presented at AAAAI"

By Ed Susman PHILADELPHIA -- March 18, 2008 -- Patients who were treated with ciclesonide nasal aerosol were able to reduce symptoms of seasonal allergic rhinitis better than subjects on a placebo spray, researchers reported here at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI 2008). The study tested the effectiveness of a new formulation of the nasal spray. Unlike previous aqueous-based sprays, the new formula uses a hydrofluoroalkane nasal aerosol. "The effect sizes and results are comparable with previous trials of ciclesonide nasal spray," said Eli Meltzer, MD, Co-Director, Allergy and Asthma Medical Group and Research Center, and Clinical Professor of Pediatrics, University of California, San Diego, California. In his poster presentation on March 15, Dr. Meltzer described the findings from a dose-ranging study, which assigned 122 patients to ciclesonide 75 mcg/day, 125 patients to 150 mcg/day, 136 patients to 300 mcg/day, and 120 patients to a placebo spray. Patients were followed over a 14-day period using total nasal symptoms score (TNSS), the primary endpoint. Reductions in TNSS from baseline were 1.14 points with placebo, 1.89 points with ciclesonide 75 mcg/day ([P = .002 vs placebo), 2 points with ciclesonide 150 mcg/day (P < .001 vs placebo), and 1.89 points with ciclesonide 300 mcg/day (P = .003 vs placebo).

"Ciclesonide 150 mcg/day demonstrated a small numeric improvement in the primary endpoint and had a faster onset of action versus the 300-mcg/day and 75-mcg/day doses," Dr. Meltzer said. "There were no clinically meaningful differences versus placebo or between doses in the incidence of adverse events."

About 3.1% of patients taking placebo experienced adverse events, primarily nasal discomfort. Rates of adverse events with ciclesonide were 6.5% in the 75-mcg/day group, 1.6% with the 150-mcg/day dose (nasal discomfort and epistaxis), and 5.9% in the 300-mcg/group. Headache was the most frequent of the recorded events.

Funding for this study was provided by Sepracor.

[Presentation title: Effectiveness of Ciclesonide Nasal Aerosol in Adult and Adolescent Patients With Seasonal Allergic Rhinitis. Abstract 206]

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