Effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis

Background: Ciclesonide is an investigational corticosteroid under development for treatment of allergic rhinitis. Ciclesonide is converted to active metabolite, desisobutyryl-ciclesonide (des-CIC), by upper and lower airway esterases. In vitro studies in human nasal epithelial cells and bronchial epithelial cells have demonstrated a long duration of anti-inflammatory activity of des-CIC. Objective: To evaluate the dose-dependent efficacy and safety of a hypotonic intranasal formulation of ciclesonide in patients with seasonal allergic rhinitis (SAR). Methods: This was a phase 2, randomized, parallel-group, double-blind, placebo-controlled study. Adults (n = approximately 145 per treatment group) with a minimum 2-year history of SAR received placebo or ciclesonide (25, 50, 100, or 200 mu g/d) for 14 days. The primary end point was change in the sum of morning and evening reflective total nasal symptom scores (TNSSs) over 2 weeks. Safety was monitored throughout the study. Results: Ciclesonide, 100 mu g/d (P = .04) and 200 mu g/d (P = .003), significantly improved the sum of morning and evening reflective TNSS vs placebo at more than 2 weeks of treatment. Baseline values for morning and evening reflective TNSS ranged from 17.80 to 18.82 across treatment groups. The average change from baseline in reflective TNSS was -4.2 for placebo and -4.8, -4.8, -5.3, and -5.8 for ciclesonide, 25, 50, 100, and 200 mu g/d, respectively. There were no dose-related differences in the incidence of adverse events among treatment groups. Conclusions: Results from this study indicate that 100-mu g and 200-mu g daily doses of ciclesonide are effective in the treatment of SAR. Ciclesonide, 200 mu g/d, appears to be the optimal dose studied for reducing the symptoms of SAR while maintaining an acceptable safety profile.