Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.
M et P Pharma AG, Emmetten, Switzerland.
Int Arch Allergy Immunol. 2020;181(5):385-394. doi: 10.1159/000506129. Epub 2020 Apr 7.
Drug-free viscous nasal applications have been shown to reduce nasal symptoms in individuals with seasonal allergic rhinitis (SAR). Nascum®-Plus (NP), a commercially available thixotropic gel, has been designed to reduce dryness and soreness of the nasal mucosa and prevent the absorption of small particles.
The aim of this study was to assess the efficacy of single-dose NP in treating nasal symptoms and secretion during challenge in an allergen challenge chamber (ACC). Furthermore, the effect of this treatment on biomarkers and immune cells of the allergic cascade were measured.
This open-label, cross-over, sequence-randomized, monocentric trial randomized 18 adults with SAR and a positive skin prick test reaction to Dactylis glomerata pollen to receive NP or no treatment during two 4-h ACC sessions 3 weeks apart. On Day 1, 9 subjects were challenged for 4 h with treatment, the other 9 without treatment, and vice versa on Day 22. Nasal lavage fluid and nasal filter eluate samples were obtained pre, 2, and 18 h post challenge in the ACC.
NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed. The treatment was safe and well-tolerated.
The physical barrier built by NP nasal gel can be safely applied in patients with allergic rhinitis. It reduces allergic nasal symptoms and secretion, but application of a single dose does not affect local inflammatory biomarkers.
无药物粘性鼻腔应用已被证明可减轻季节性过敏性鼻炎（SAR）患者的鼻部症状。Nascum®-Plus（NP）是一种市售的触变凝胶，旨在减少鼻黏膜的干燥和疼痛，并防止小颗粒的吸收。
本研究旨在评估单剂量 NP 在变应原激发室内（ACC）治疗激发时鼻部症状和分泌物的疗效。此外，还测量了这种治疗对过敏级联反应中生物标志物和免疫细胞的影响。
这是一项开放标签、交叉、随机、单中心试验，将 18 名 SAR 患者和对 Dactylis glomerata 花粉皮肤点刺试验阳性的患者随机分为两组，在相隔 3 周的两次 4 小时 ACC 期间接受 NP 或不治疗。第 1 天，9 名患者接受 4 小时治疗，另 9 名患者接受 4 小时无治疗，第 22 天反之亦然。在 ACC 中，在挑战前、2 小时和 18 小时后获得鼻冲洗液和鼻滤器洗脱液样本。
NP 显著减轻了鼻部症状，总鼻部症状评分（p <0.001），并最小化了鼻部分泌（p = 0.047），而对鼻液中的生物标志物和免疫细胞没有显著影响。治疗安全且耐受良好。
NP 鼻腔凝胶构建的物理屏障可安全应用于过敏性鼻炎患者。它可减轻过敏性鼻部症状和分泌物，但单次应用不会影响局部炎症生物标志物。
