Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 μg once daily, for the treatment of seasonal allergic rhinitis

Background: A hypotonic aqueous nasal spray of ciclesonide is indicated for the treatment of allergic rhinitis (AR). A new nasal aerosol formulation of ciclesonide containing a hydrofluoroalkane propellant delivered via a metered-dose inhaler (CIC-HFA) is currently in clinical development as a potential treatment for AR.Objectives: To study the efficacy and safety of once-daily administration of CIC-HFA 80 or 160 mu g compared with placebo in subjects 12 years and older with seasonal AR (SAR).Methods: Subjects 12 years and older with a >= 2-year history of SAR were randomized in a placebo-controlled, double-blind, parallel-group, multicenter study to receive CIC-HFA 80 or 160 mu g or placebo once daily in the morning for 2 weeks. Changes from baseline in reflective total nasal symptom scores (rTNSSs), instantaneous TNSSs (iTNSSs), and reflective total ocular symptom scores (rTOSSs) in subjects with a baseline rTOSS of >= 5.00 were evaluated. Treatment-emergent adverse events were monitored throughout the study.Results: Seven hundred seven subjects were randomized. From baseline, CIC-HFA 80 or 160 mu g demonstrated 15.1% and 16.0% reductions in rTNSSs (P < .0001, 3.7% for placebo), 14.3% and 15.4% reductions in iTNSSs (P < .0001, 3.9% for placebo), and 15.7% and 15.0% reductions in rTOSSs (P < .001, 6.8% for placebo). The overall incidence of treatment-emergent adverse events was low and comparable between the CIC-HFA and placebo groups.Conclusions: In this study, once-daily treatment with CIC-HFA 80 or 160 mu g demonstrated statistically significant improvements in nasal and ocular symptoms of SAR. Both doses of active treatment were well tolerated. Ann Allergy Asthma Immunol. 2010;105:471-479.

背景：环索奈德低渗鼻腔喷雾剂适用于过敏性鼻炎（AR）的治疗。一种含有氢氟烷烃推进剂的新型环索奈德鼻腔气雾剂制剂，通过定量吸入器给药（CIC - HFA），目前正处于临床研发阶段，作为AR的一种潜在治疗方法。 目的：研究在12岁及以上季节性过敏性鼻炎（SAR）患者中，每日一次给予80μg或160μg的CIC - HFA与安慰剂相比的疗效和安全性。 方法：12岁及以上、有≥2年SAR病史的患者，在一项安慰剂对照、双盲、平行组、多中心研究中被随机分组，在早晨每日一次接受80μg或160μg的CIC - HFA或安慰剂，持续2周。对基线反射性总鼻症状评分（rTNSSs）≥5.00的患者，评估其rTNSSs、瞬时鼻症状评分（iTNSSs）和反射性总眼症状评分（rTOSSs）相对于基线的变化。在整个研究过程中监测治疗期间出现的不良事件。 结果：707名患者被随机分组。与基线相比，80μg或160μg的CIC - HFA使rTNSSs分别降低15.1%和16.0%（P <.0001，安慰剂为3.7%），使iTNSSs分别降低14.3%和15.4%（P <.0001，安慰剂为3.9%），使rTOSSs分别降低15.7%和15.0%（P <.001，安慰剂为6.8%）。治疗期间出现的不良事件总体发生率较低，且CIC - HFA组和安慰剂组之间相当。 结论：在本研究中，每日一次使用80μg或160μg的CIC - HFA治疗，在SAR的鼻和眼症状方面显示出统计学上的显著改善。两种剂量的活性治疗均耐受性良好。《过敏、哮喘与免疫学纪事》2010年；105：471 - 479。