Onset of action of ciclesonide once daily in the treatment of seasonal allergic rhinitis

Background: Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR). Objective: To evaluate the time to onset of action of ciclesonide, 200 mu g/d., in patients with seasonal AR (SAR). Methods: In a double-blind, randomized, placebo-controlled study conducted in an environmental exposure chamber, 509 adults with at least a 2-year history of SAR completed I to 5 priming sessions of ragweed pollen exposure (mean [SD] of 3,500 [500] grains/m(3)). Patients with successful priming visits (defined as patient-assessed instantaneous total nasal symptom scores [TNSSs] >= 6 and rhinorrhea or nasal congestion scores 2::2) received a single dose of intranasal ciclesonide. 200 (n = 255), or placebo (n = 254). The difference in the change from baseline in TNSSs between the ciclesonide and placebo groups was measured hourly I to 12 hours after study drug administration. Results: At hour 6, the mean treatment difference in TNSSs between ciclesonide and placebo was 0.53 (95% confidence interval, 0.03-1.03; P = .02). Significant treatment differences in favor of ciclesonide were also observed at 2 additional time points: hour 10 (P = .01) and hour 12 (P = .008). Conclusions: These results confirm that intranasal ciclesonide, 200 mu g/d, has an onset of action of 6 hours in patients with SAR.