Ratner Paul H, Wingertzahn Mark A, van Bavel Julius H, Hampel Frank, Darken Patrick F, Shah Tushar
Sylvana Research, Department of Pediatrics, University of Texas Health Science Center, San Antonio, TX 78229, USA.
J Allergy Clin Immunol. 2006 Nov;118(5):1142-8. doi: 10.1016/j.jaci.2006.07.050. Epub 2006 Sep 25.
Allergic rhinitis (AR), an inflammatory disease of the nasal mucosa, affects approximately 25% of adults and 40% of children in the United States. Ciclesonide nasal spray is a corticosteroid being developed as a hypotonic formulation for AR.
We sought to evaluate the efficacy, safety, and tolerability of ciclesonide nasal spray in adult and adolescent patients with seasonal AR (SAR).
In this double-blind study patients (age, >or=12 years) were randomized to receive 200 microg of intranasal ciclesonide (n = 164) or placebo (n = 163) once daily for 28 days. The primary measure was morning and evening patient-assessed reflective total nasal symptom score (TNSS). Additionally, instantaneous TNSSs, physician-assessed overall nasal signs and symptoms severity, and the results of the Rhinoconjunctivitis Quality of Life Questionnaire were evaluated. Adverse events were monitored throughout the study.
Ciclesonide significantly improved average morning and evening reflective and instantaneous TNSSs compared with placebo over days 1 to 14 (P < .001). Improvements were also noted over days 1 to 28 (P < .001) and over days 15 to 28 (P = .011). Ciclesonide was well tolerated.
Intranasal ciclesonide was superior to placebo in relieving nasal symptoms in adult and adolescent patients with SAR. These results confirm the dose range-finding study in patients with SAR and support the efficacy of ciclesonide in AR.
In a clinical setting ciclesonide was shown to be safe and effective in the treatment of SAR in adolescent and adult patients.
变应性鼻炎（AR）是一种鼻黏膜炎症性疾病，在美国约25%的成年人和40%的儿童受其影响。环索奈德鼻喷雾剂是一种正在研发的用于AR的低渗制剂。
我们旨在评估环索奈德鼻喷雾剂在成年和青少年季节性AR（SAR）患者中的疗效、安全性和耐受性。
在这项双盲研究中，年龄≥12岁的患者被随机分组，每天一次接受200μg鼻内用环索奈德（n = 164）或安慰剂（n = 163），共28天。主要测量指标为患者早晚自我评估的反射性总鼻症状评分（TNSS）。此外，还评估了即时TNSS、医生评估的总体鼻体征和症状严重程度以及变应性鼻结膜炎生活质量问卷的结果。在整个研究过程中监测不良事件。
与安慰剂相比，在第1至14天，环索奈德显著改善了平均早晚反射性和即时TNSS（P <.001）。在第1至28天（P <.001）以及第15至28天（P =.011）也观察到了改善。环索奈德耐受性良好。
鼻内用环索奈德在缓解成年和青少年SAR患者的鼻症状方面优于安慰剂。这些结果证实了在SAR患者中进行的剂量探索性研究，并支持环索奈德在AR中的疗效。
在临床环境中，环索奈德被证明在治疗青少年和成年患者的SAR方面是安全有效的。
