Unger-Manhart Nicole, Morokutti-Kurz Martina, Zieglmayer Petra, Russo Antonella, Siegl Cornelia, König-Schuster Marielle, Koller Christiane, Graf Philipp, Graf Christine, Lemell Patrick, Savli Markus, Zieglmayer René, Dellago Hanna, Prieschl-Grassauer Eva
Marinomed Biotech AG, Korneuburg, Austria.
Vienna Challenge Chamber, Vienna, Austria.
Int J Gen Med. 2024 Nov 8;17:5105-5121. doi: 10.2147/IJGM.S476707. eCollection 2024.
This study aimed to develop a hyperosmolar, barrier-forming nasal spray based on carrageenan and sorbitol, and to demonstrate its decongestant effect in the context of allergic rhinitis (AR).
The efficacy of the nasal spray components was tested in vitro by barrier function, virus replication inhibition, and water absorption assays. The decongestant effectiveness was assessed in a randomized, controlled, crossover environmental chamber trial, where participants with a history of seasonal grass pollen AR were exposed to grass pollen allergens under controlled conditions. Forty-one adults were randomized to receive either carrageenan- and sorbitol-containing nasal spray (CS) or saline solution (SS). After 1 week, participants repeated the exposure with the treatment they had not received before. The primary efficacy endpoint was the mean change in nasal congestion symptom score (NCSS). Secondary efficacy endpoints were nasal airflow, nasal secretion, total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total respiratory symptom score (TRSS).
Preclinical assays demonstrated barrier-building, virus-blocking, and water-withdrawing properties of the CS components. In the clinical study, there was no significant difference in mean NCSS change from pre- to post-treatment between CS and SS. However, nasal airflow increased over time after treatment with CS, while it declined after SS, leading to a growing difference in airflow between CS and SS (p = 0.04 at 6:00 h). Mean nasal secretion over 2-6 h was reduced by ~25% after CS (p = 0.003) compared to pre-treatment, while it was reduced by only ~16% after SS (p = 0.137). No significant differences in TNSS, TOSS and TRSS were observed between CS and SS.
CS improves nasal airflow and reduces nasal secretion in adults with AR. We propose CS as a safe and effective adjuvant to baseline pharmacological treatments.
NCT04532762.
本研究旨在研发一种基于角叉菜胶和山梨醇的高渗屏障形成型鼻喷雾剂，并在变应性鼻炎（AR）背景下证明其减充血作用。
通过屏障功能、病毒复制抑制和吸水试验在体外测试鼻喷雾剂成分的功效。在一项随机、对照、交叉环境舱试验中评估减充血效果，有季节性草花粉AR病史的参与者在受控条件下暴露于草花粉过敏原。41名成年人被随机分为接受含角叉菜胶和山梨醇的鼻喷雾剂（CS）或盐溶液（SS）。1周后，参与者用他们之前未接受过的治疗重复暴露。主要疗效终点是鼻充血症状评分（NCSS）的平均变化。次要疗效终点是鼻气流、鼻分泌物、总鼻症状评分（TNSS）、总眼症状评分（TOSS）和总呼吸症状评分（TRSS）。
临床前试验证明了CS成分的屏障构建、病毒阻断和吸水特性。在临床研究中，CS和SS治疗前后NCSS平均变化无显著差异。然而，CS治疗后鼻气流随时间增加，而SS治疗后鼻气流下降，导致CS和SS之间气流差异增大（6:00时p = 0.04）。与治疗前相比，CS治疗后2 - 6小时的平均鼻分泌物减少了约25%（p = 0.003），而SS治疗后仅减少了约16%（p = 0.137）。CS和SS之间在TNSS、TOSS和TRSS方面未观察到显著差异。
CS可改善AR成人的鼻气流并减少鼻分泌物。我们建议将CS作为基线药物治疗的安全有效辅助药物。
NCT04532762。
