Couroux Peter, Kunjibettu Sudeesha, Hall Nancy, Wingertzahn Mark A
Allied Research International-Cetero Research, Mississauga, Ontario, Canada.
Ann Allergy Asthma Immunol. 2009 Jan;102(1):62-8. doi: 10.1016/S1081-1206(10)60110-X.
Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR).
To evaluate the time to onset of action of ciclesonide, 200 microg/d, in patients with seasonal AR (SAR).
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.
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).
These results confirm that intranasal ciclesonide, 200 microg/d, has an onset of action of 6 hours in patients with SAR.
环索奈德是一种经批准用于治疗变应性鼻炎（AR）的鼻用皮质类固醇。
评估200μg/d环索奈德对季节性AR（SAR）患者的起效时间。
在环境暴露舱中进行的一项双盲、随机、安慰剂对照研究中，509名有至少2年SAR病史的成年人完成了1至5次豚草花粉暴露激发试验（平均[标准差]为3500[500]粒/m³）。激发试验成功的患者（定义为患者评估的即时总鼻症状评分[TNSS]≥6且流涕或鼻塞评分为-2）接受单剂量200μg鼻用环索奈德（n = 255）或安慰剂（n = 254）。在给予研究药物后1至12小时每小时测量环索奈德组和安慰剂组TNSS相对于基线变化的差异。
在第6小时，环索奈德组和安慰剂组TNSS的平均治疗差异为0.53（95%置信区间，0.03 - 1.03；P = 0.02）。在另外两个时间点也观察到了有利于环索奈德的显著治疗差异：第10小时（P = 0.01）和第12小时（P = 0.008）。
这些结果证实，200μg/d鼻用环索奈德对SAR患者的起效时间为6小时。
