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 microg/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 1 to 5 priming sessions of ragweed pollen exposure (mean [SD] of 3,500 [500] grains/m3). Patients with successful priming visits (defined as patient-assessed instantaneous total nasal symptom scores [TNSSs] > or =6 and rhinorrhea or nasal congestion scores -2) received a single dose of intranasal ciclesonide, 200 microg (n = 255), or placebo (n = 254). The difference in the change from baseline in TNSSs between the ciclesonide and placebo groups was measured hourly 1 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 microg/d, has an onset of action of 6 hours in patients with SAR.