Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.
Altamira Medica AG, Zug, Switzerland.
Int Arch Allergy Immunol. 2023;184(2):111-121. doi: 10.1159/000526423. Epub 2022 Nov 2.
Symptoms of allergic rhinitis can be reduced by nonpharmacological nasal sprays that create a barrier between allergens and the nasal mucosa. A new nasal spray (AM-301) containing the clay mineral bentonite was tested for its ability to reduce symptoms of grass pollen.
This open-label, crossover, noninferiority trial compared the efficacy and safety of AM-301 to that of hydroxypropyl methylcellulose (HPMC; Nasaleze® Allergy Blocker), an established barrier method. Adults with seasonal allergic rhinitis were exposed to Dactylis glomerata pollen, in a controlled setting, the Fraunhofer allergen challenge chamber, first without protection and then protected by HPMC or AM-301 (7 days apart). Efficacy was assessed from total nasal symptom score (TNSS), nasal secretion weight, and subjective rating. The primary endpoint was the difference, between AM-301 and HPMC, in least square mean change in TNSS over a 4-h exposure to allergen.
The study enrolled 36 persons, and 35 completed all study visits. The mean TNSS was 5.91 (SD = 1.45) during unprotected exposure, 5.20 (SD = 1.70) during protection with HPMC, and 4.82 (SD = 1.74) during protection with AM-301. The difference in least square means between the two treatments was -0.39 (95% CI: -0.89 to 0.10), establishing the noninferiority of AM-301. No difference in mean weight of nasal secretions was observed between the treatments. Efficacy was rated as good or very good for AM-301 by 31% and for HPMC by 14% of subjects. Sixteen subjects reported adverse events with a relationship to AM-301 or HPMC; most adverse events were mild, and none was serious.
DISCUSSION/CONCLUSION: AM-301 demonstrated noninferiority toward HPMC in the primary endpoint and was perceived better in subjective secondary endpoints. Both barrier-forming products had a persisting protective effect over 4 h and were safe.
通过在过敏原和鼻黏膜之间形成屏障的非药物性鼻腔喷雾剂，可以减轻过敏性鼻炎的症状。一种含有膨润土的新型鼻腔喷雾剂（AM-301）已被测试其减轻草花粉症状的能力。
这项开放标签、交叉、非劣效性试验比较了 AM-301 与羟丙基甲基纤维素（HPMC；Nasaleze® Allergy Blocker）的疗效和安全性，HPMC 是一种已确立的屏障方法。在受控环境 Fraunhofer 过敏原挑战室中，首先让患有季节性过敏性鼻炎的成年人接触 Dactylis glomerata 花粉，然后分别用 HPMC 或 AM-301（相隔 7 天）进行保护，评估疗效从总鼻症状评分（TNSS）、鼻分泌物重量和主观评分。主要终点是 AM-301 与 HPMC 之间，在 4 小时暴露于过敏原期间 TNSS 最小平方均数变化的差异。
该研究共纳入 36 人，35 人完成了所有研究访问。未受保护暴露时的平均 TNSS 为 5.91（SD=1.45），用 HPMC 保护时为 5.20（SD=1.70），用 AM-301 保护时为 4.82（SD=1.74）。两种治疗方法之间最小平方均数的差异为-0.39（95%CI：-0.89 至 0.10），确立了 AM-301 的非劣效性。两种治疗方法之间的鼻分泌物平均重量无差异。31%的受试者认为 AM-301 有效或非常有效，14%的受试者认为 HPMC 有效或非常有效。16 名受试者报告了与 AM-301 或 HPMC 有关的不良事件；大多数不良事件为轻度，无严重不良事件。
讨论/结论：AM-301 在主要终点方面表现出非劣效性，在主观次要终点方面被认为更好。两种形成屏障的产品均具有 4 小时以上的持续保护作用且安全。
