University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pa.
University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pa.
J Allergy Clin Immunol Pract. 2024 Apr;12(4):1049-1061. doi: 10.1016/j.jaip.2023.12.016. Epub 2024 Jan 18.
Chronic rhinosinusitis (CRS) is a prevalent inflammatory disease. No medications are Food and Drug Administration-approved for the most common form, CRS without nasal polyps (also called "chronic sinusitis"). Novel biomechanics of the exhalation delivery system deliver fluticasone (EDS-FLU; XHANCE) to sinonasal areas above the inferior turbinate, especially sinus drainage pathways not reached by standard-delivery nasal sprays.
Assess EDS-FLU efficacy for CRS (irrespective of nasal polyps).
Two randomized, EDS-placebo-controlled trials in adults with CRS irrespective of polyps (ReOpen1) or exclusively without polyps (ReOpen2) were conducted at 120 sites in 13 countries. Patients received EDS-FLU 1 or 2 sprays/nostril, or EDS-placebo, twice daily for 24 weeks. Coprimary measures were composite symptom score through week 4 and ethmoid/maxillary sinus percent opacification by computed tomography at week 24.
ReOpen1 (N = 332) composite symptom score least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -1.58 and -1.60 versus -0.62 (P < .001, P < .001); ReOpen2 (N = 223), -1.54 and -1.74 versus -0.81 (P = .011, P = .001). In ReOpen1, sinus opacification least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -5.58 and -6.20 versus -1.60 (P = .045, P = .018), and in ReOpen2, -7.00 and -5.14 versus +1.19 (P < .001, P = .009). Acute disease exacerbations were reduced by 56% to 66% with EDS-FLU versus EDS-placebo (P = .001). There were significant, and similar magnitude, symptom reductions in patients using standard-delivery nasal steroid products just before entering the study (P < .001). Adverse events were similar to standard-delivery intranasal steroids.
EDS-FLU is the first nonsurgical treatment demonstrated to reduce symptoms, intrasinus opacification, and exacerbations in replicate randomized clinical trials in CRS, regardless of polyp status.
慢性鼻-鼻窦炎（CRS）是一种常见的炎症性疾病。没有药物被美国食品和药物管理局批准用于最常见的形式，即没有鼻息肉的 CRS（也称为“慢性鼻窦炎”）。新型呼气输送系统的生物力学将氟替卡松（EDS-FLU；XHANCE）输送到鼻甲上方的鼻-鼻窦区域，特别是标准输送鼻腔喷雾剂无法到达的窦引流途径。
评估 EDS-FLU 治疗 CRS（不论是否有鼻息肉）的疗效。
在 13 个国家的 120 个地点进行了两项随机、EDS-安慰剂对照试验，纳入了有或无鼻息肉的 CRS 成年患者（ReOpen1）或仅无鼻息肉的 CRS 成年患者（ReOpen2）。患者接受 EDS-FLU 每次每侧鼻腔喷 1 或 2 次，或 EDS-安慰剂，每天 2 次，持续 24 周。主要复合指标是第 4 周的综合症状评分和第 24 周的计算机断层扫描额窦/上颌窦的混浊百分比。
ReOpen1（N=332）中 EDS-FLU 每次每侧鼻腔喷 1 或 2 次与 EDS-安慰剂相比，复合症状评分的最小二乘均数变化分别为-1.58 和-1.60 与-0.62（P<0.001，P<0.001）；ReOpen2（N=223）中，分别为-1.54 和-1.74 与-0.81（P=0.011，P=0.001）。在 ReOpen1 中，EDS-FLU 每次每侧鼻腔喷 1 或 2 次与 EDS-安慰剂相比，窦混浊的最小二乘均数变化分别为-5.58 和-6.20 与-1.60（P=0.045，P=0.018），在 ReOpen2 中，分别为-7.00 和-5.14 与+1.19（P<0.001，P=0.009）。与 EDS-安慰剂相比，EDS-FLU 使急性疾病恶化减少了 56%至 66%（P=0.001）。在进入研究之前使用标准鼻腔类固醇产品的患者中，症状有显著且相似程度的减轻（P<0.001）。不良反应与标准鼻腔内类固醇相似。
在复发性随机临床试验中，EDS-FLU 是第一个被证明可减轻症状、窦内混浊和恶化的非手术治疗方法，无论息肉状态如何。
