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首页> 外文期刊>Allergy >Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis.
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Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis.

机译：糠酸氟替卡松鼻喷雾剂对常年性变应性鼻炎的成人和青少年的长期安全性。

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Background: Fluticasone furoate is a novel-enhanced affinity glucocorticoid and its long-term safety must be assessed. This study was designed to assess the safety and tolerability of 12-month intranasal administration of fluticasone furoate in adult and adolescent patients with perennial allergic rhinitis (PAR). Methods: In this randomized, double-blind, placebo-controlled, parallel-group study, 806 patients with PAR were randomized to once daily (od) fluticasone furoate nasal spray 110 mug (n = 605) or vehicle placebo nasal spray (n = 201) for 12 months, following a 7- to 14-day screening period. Safety was assessed by monitoring adverse events (AEs), 24-h urinary cortisol excretion, nasal and ophthalmic examinations, electrocardiograms and clinical laboratory tests. Plasma concentrations of fluticasone furoate were determined from blood samples. Results: Fluticasone furoate was well tolerated. The incidence of most AEs was similar to that observed with placebo, with the exception of epistaxis, whichwas more frequently reported on active treatment. There were no clinically meaningful differences between fluticasone furoate and placebo in terms of safety assessments, including mean changes in ophthalmic parameters and 24-h urine cortisol excretion. Plasma concentrations of fluticasone furoate were not quantifiable in the majority of patients following intranasal administration. Conclusions: Long-term (12-month) administration of fluticasone furoate 110 mug od revealed an AE profile typical of the intranasal corticosteroid class in both adult and adolescent patients with PAR, with no evidence of clinically relevant systemic corticosteroid exposure.
机译：背景：氟替卡松糠酸酯是一种新型的亲和性糖皮质激素，必须评估其长期安全性。本研究旨在评估氟替卡松糠酸酯在成人和青少年常年性变应性鼻炎（PAR）患者中12个月鼻内给药的安全性和耐受性。方法：在这项随机，双盲，安慰剂对照的平行组研究中，将806例PAR患者随机分配到每天一次（od）糠酸氟替卡松鼻喷雾剂110杯（n = 605）或赋形剂安慰剂鼻喷雾剂（n = 201），为期7到14天的筛选期后的12个月。通过监测不良事件（AE），24小时尿皮质醇排泄，鼻腔和眼科检查，心电图和临床实验室检查来评估安全性。从血样中测定氟替卡松糠酸酯的血浆浓度。结果：氟替卡松糠酸酯耐受性良好。除鼻出血外，大多数不良事件的发生率与安慰剂相似，但在主动治疗中更为常见。在安全性评估方面，糠酸氟替卡松与安慰剂之间在临床上没有有意义的区别，包括眼科参数的平均变化和24小时尿皮质醇排泄。鼻内给药后大多数患者的血浆氟替卡松浓度无法确定。结论：糠酸氟替卡松110杯od的长期（12个月）给药显示，成人和青少年PAR患者的鼻内皮质类固醇类型均具有典型的AE分布，没有临床相关的全身性皮质类固醇暴露的证据。

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