Portal de Periódicos da CAPES

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

2009; Elsevier BV; Volume: 102; Issue: 1 Linguagem: Inglês

10.1016/s1081-1206(10)60110-x

1534-4436

Peter Couroux, Sudeesha Kunjibettu, Nancy Hall, Mark A. Wingertzahn,

Olfactory and Sensory Function Studies

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 μg/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/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) received a single dose of intranasal ciclesonide, 200 μg (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 μg/d, has an onset of action of 6 hours in patients with SAR.