Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis
Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis
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DOI：
10.1016/s1081-1206(10)60624-2
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发表时间：
2007-07-01
影响因子：
5.9
通讯作者：
Shah, Tushar
中科院分区：
文献类型：
--
作者：
Chervinsky, Paul;Kunjibettu, Sudeesha;Shah, Tushar
背景资料：环索奈德是一种正在开发的用于过敏性鼻炎的皮质类固醇，在长达6周的季节性过敏性鼻炎和常年性过敏性鼻炎（PAR）试验中已被证明是安全有效的。然而，环索奈德的长期安全性和有效性尚不清楚。目的：证明PAR患者鼻内环索奈德200 μ g每日一次的长期安全性。患者（≥ 12岁）有2年或更长PAR病史的患者以双盲方式随机接受环索奈德，200 μ g，或安慰剂，每天早晨一次，持续52周。在整个研究过程中监测自发和诱发的不良事件。进行耳、鼻和喉检查以评价局部耐受性。此外，监测24小时尿游离皮质醇水平、早晨血浆皮质醇水平、眼内压和透镜混浊，以评价鼻内环索奈德的全身安全性。环索奈德疗效测定24小时反射总鼻症状scores.Results：没有临床相关的差异，观察环索奈德和安慰剂组之间的不良事件，耳，鼻，咽喉检查，或24小时尿游离或早晨血浆皮质醇水平。同样，在眼内压、视力或透镜混浊方面，未发现治疗组间存在临床相关差异。在疗效方面，环索奈德与安慰剂相比，在超过52周的时间内，24小时反射性总鼻症状评分显著降低（P <0.001）。结论：在这项研究中，鼻内环索奈德，200 μ g，每日一次，对PAR的长期治疗是安全有效的，没有快速耐受的证据。
Background: Ciclesonide is a corticosteroid in development for allergic rhinitis that has been shown to be safe and effective in seasonal allergic rhinitis and perennial allergic rhinitis (PAR) trials of up to 6 weeks in duration. However, the long-term safety and efficacy of ciclesonide are unknown.Objective: To demonstrate the long-term safety of intranasal ciclesonide, 200 mu g once daily, in patients with PAR.Methods: Patients (>= 12 years old) with a 2-year or longer history of PAR were randomized in a double-blind fashion to receive ciclesonide, 200 mu g, or placebo once daily in the morning for up to 52 weeks. Spontaneous and elicited adverse events were monitored throughout the study. Ear, nose, and throat examinations were performed to evaluate local tolerability. Additionally, 24-hour urinary free cortisol level, morning plasma cortisol level, intraocular pressure, and lens opacification were monitored to evaluate the systemic safety of intranasal ciclesonide. Ciclesonide efficacy was determined by measuring 24-hour reflective total nasal symptom scores.Results: No clinically relevant differences were observed between the ciclesonide and placebo groups in adverse events, ear, nose, and throat examinations, or 24-hour urinary free or morning plasma cortisol levels. Similarly, no clinically relevant differences were found between treatment groups in intraocular pressure, visual acuity, or lens opacification. With regard to efficacy, ciclesonide achieved a significantly greater reduction in 24-hour reflective total nasal symptom score compared with placebo over more than 52 weeks (P < .001).Conclusion: In this study, intranasal ciclesonide, 200 mu g once daily, was safe and effective for the long-term treatment of PAR, with no evidence of tachyphylaxis.