Bon Secours Consultant Private Clinic, Beacon ENT and Allergy Clinic at Beacon Hospital, Dublin, Ireland.
Meda Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany.
Immun Inflamm Dis. 2018 Dec;6(4):456-464. doi: 10.1002/iid3.237. Epub 2018 Oct 11.
Most allergic rhinitis (AR) patients have moderate-to-severe, persistent disease. Meda Pharma's AzeFlu (MP-AzeFlu) combines intranasal azelastine hydrochloride (AZE) and fluticasone propionate (FP) in a novel formulation in a single device to treat AR. This prospective, noninterventional study sought to assess the effectiveness of MP-AzeFlu (one spray/nostril twice daily; 548 µg AZE/200 µg FP daily dose) in relieving AR symptom severity.
A visual analogue scale (VAS) was used prior to MP-AzeFlu treatment on days 0, 1, 3, 7, 14, 21, 28, 35, and 42 by 53 persistent AR (PER) patients seen in routine clinical practice in Ireland. An endoscopy was performed on days 0 and 28, and symptoms of edema, discharge, and redness were scored on a three-point scale (for both nostrils).
Patients using MP-AzeFlu experienced rapid VAS score reduction from 73.4 mm (standard deviation [SD], 20.3) at Day 0 to 31.5 mm (SD, 25.0) at day 28 (P < 0.0001) to 28.1 mm (SD, 24.1) at day 42 (P < 0.0001), a 45.3-mm reduction. On average, patients achieved a clinically relevant VAS score cutoff of 50 mm before Day 7. Total endoscopy score decreased from 7.5 mm (SD, 3.1) at baseline to 3.5 mm (SD, 2.5) at Day 28. The incidence of severe edema on endoscopy decreased from 53.1% at baseline to 3.8% at Day 28. A similar reduction in the incidence of thick/mucousy discharge (from 28.3% to 4.8%) and severe redness (from 34.9% to 0%) was also observed.
MP-AzeFlu provided effective, rapid control of PER as assessed by VAS in a real-world clinical setting in Ireland. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved mucosal appearance after 28 days. These results confirm the safety of MP-AzeFlu and exceed the efficacy demonstrated in phase 3 clinical studies for controlling AR in PER patients.
大多数过敏性鼻炎（AR）患者的疾病为中重度持续性。Mepa 制药公司的 AzeFlu（MP-AzeFlu）将盐酸氮卓斯汀（AZE）和丙酸氟替卡松（FP）联合制成一种新制剂，装在一个装置中，用于治疗 AR。这项前瞻性、非干预性研究旨在评估 MP-AzeFlu（每日每侧鼻腔喷 2 次，每次 1 喷；每日剂量为 AZE548µg 和 FP200µg）在缓解 AR 症状严重程度方面的疗效。
在爱尔兰常规临床实践中，53 例持续性 AR（PER）患者在接受 MP-AzeFlu 治疗前的第 0、1、3、7、14、21、28、35 和 42 天使用视觉模拟量表（VAS）进行评估。在第 0 和 28 天进行内窥镜检查，并对每个鼻孔的水肿、分泌物和发红症状进行三分制评分。
使用 MP-AzeFlu 的患者 VAS 评分从第 0 天的 73.4mm（标准差 [SD]，20.3）迅速降至第 28 天的 31.5mm（SD，25.0）（P<0.0001），并在第 42 天（P<0.0001）降至 28.1mm（SD，24.1），降低了 45.3mm。平均而言，患者在第 7 天前达到了有临床意义的 VAS 评分 50mm。总内窥镜评分从基线时的 7.5mm（SD，3.1）降至第 28 天的 3.5mm（SD，2.5）。内窥镜检查时严重水肿的发生率从基线时的 53.1%降至第 28 天的 3.8%。同样，厚/黏液分泌物（从 28.3%降至 4.8%）和严重发红（从 34.9%降至 0%）的发生率也有所下降。
在爱尔兰的真实临床环境中，MP-AzeFlu 通过 VAS 评估，为 PER 患者提供了有效且快速的控制。在第 1 天就观察到症状改善，并持续 42 天，28 天后黏膜外观也得到改善。这些结果证实了 MP-AzeFlu 的安全性，并超过了在 PER 患者中控制 AR 的 3 期临床研究中显示的疗效。
