van Weissenbruch Ranny, Klimek Ludger, Gálffy Gabriella, Emmeluth Melanie, Koltun Arkady, Kopietz Ferdinand, Nguyen Duc Tung, Kuhl Hans Christian, Pohl Wolfgang, Scadding Glenis K, Price David, Mullol Joaquim
Department of ENT Head and Neck Surgery, Wilhelmina Ziekenhuis, Assen, the Netherlands.
Department of Otorhinolaryngology and Head and Neck Plastic Surgery, Zentrum für Rhinologie und Allergologie, Wiesbaden, Germany.
J Asthma Allergy. 2020 Dec 2;13:633-645. doi: 10.2147/JAA.S277734. eCollection 2020.
Patients with poorly controlled allergic rhinitis (AR) experience nasal symptoms, sleep disturbances, activity impairment, and decreased quality-of-life (QoL). MP-AzeFlu is safe and effective for moderate-to-severe seasonal and perennial AR, but its impact on QoL requires investigation in the real-world, especially among phenotypes of immunoglobulin (Ig)E-mediated AR. This subanalysis of an observational study evaluated response to MP-AzeFlu via assessment of sleep quality and trouble with daily activities.
This multicenter, prospective, non-interventional, real-life study included a convenience sample of patients with a history of moderate-to-severe AR presenting with acute AR symptoms (visual analog scale [VAS] ≥50 mm). Over approximately 14 days of treatment with MP-AzeFlu (137 µg azelastine HCL and 50 µg fluticasone propionate administered via single 0.137-mL spray in each nostril twice daily), changes in sleep quality and trouble with daily work, school, social, and outdoor activities were evaluated using a VAS for the entire study population and for four subgroups based on IgE response phenotype. VAS scores ranged from "not at all troubled" (0 mm) to "extremely troubled" (100 mm).
Following MP-AzeFlu treatment, mean VAS scores for sleep quality impairment and work or school impairment decreased from 55.2 mm at baseline to 22.1 mm and 57.6 mm at baseline to 23.0 mm, respectively, after ~14 days. Similar results were observed for mean VAS scores for impairment of social activity (55.1 mm to 22.4 mm) and impairment of outdoor activity (64.4 mm to 25.0 mm). For all VAS scores, results were similar across populations, regardless of phenotype of IgE-mediated disease, comorbidity, age, and sex.
MP-AzeFlu relieves symptoms and improves patient-reported QoL, illustrated by better sleep quality and less impairment of work, school, social, and outdoor activities after 14 days. The QoL benefits of MP-AzeFlu were consistent regardless of the phenotype of IgE-mediated disease.
Clinical Trial Registration (CTR) Number: EUPAS23075. Trial Register Date: March 12, 2018. First patient visit; Last patient visit: February 2018; April 2019.
过敏性鼻炎（AR）控制不佳的患者会出现鼻部症状、睡眠障碍、活动受限以及生活质量（QoL）下降。MP-AzeFlu对中重度季节性和常年性AR安全有效，但其对生活质量的影响需要在现实世界中进行研究，尤其是在免疫球蛋白（Ig）E介导的AR表型中。这项观察性研究的亚分析通过评估睡眠质量和日常活动困扰来评估对MP-AzeFlu的反应。
这项多中心、前瞻性、非干预性的现实生活研究纳入了有中重度AR病史且出现急性AR症状（视觉模拟量表[VAS]≥50mm）的患者的便利样本。在使用MP-AzeFlu（137μg盐酸氮卓斯汀和50μg丙酸氟替卡松，通过每次在每个鼻孔喷入0.137mL单次剂量，每日两次）进行约14天的治疗期间，使用VAS对整个研究人群以及基于IgE反应表型的四个亚组评估睡眠质量和日常工作、学校、社交及户外活动困扰的变化。VAS评分范围从“完全无困扰”（0mm）到“极度困扰”（100mm）。
MP-AzeFlu治疗后，睡眠质量受损和工作或学校活动受损的平均VAS评分分别从基线时的55.2mm降至约14天后的22.1mm，以及从基线时的57.6mm降至23.0mm。社交活动受损（从55.1mm降至22.4mm）和户外活动受损（从64.4mm降至25.0mm）的平均VAS评分也观察到类似结果。对于所有VAS评分，无论IgE介导疾病的表型、合并症、年龄和性别如何，各人群的结果相似。
MP-AzeFlu可缓解症状并改善患者报告的生活质量，表现为14天后睡眠质量更好，工作、学校、社交和户外活动的受限更少。无论IgE介导疾病的表型如何，MP-AzeFlu对生活质量的益处都是一致的。
临床试验注册号（CTR）：EUPAS23075。试验注册日期：2018年3月12日。首例患者就诊时间；末例患者就诊时间：2018年2月；2019年4月。
