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A proprietary blend of quail egg for the attenuation of nasal provocation with a standardized allergenic challenge: a randomized, double‐blind, placebo‐controlled study

机译:鹌鹑蛋的专有混合物,通过标准的变应原性挑战减轻鼻腔刺激:随机,双盲,安慰剂对照研究

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AbstractOccasional rhinitis symptoms caused by exposure to pollution or allergens is a growing concern. Based first on empirical observation of a lesser occurrence of allergies in quail farmers and then scientific works on ovomucoids properties, we developed a dietary supplement for the relief of such occasional rhinitis symptoms. The objective of the study was to determine whether one acute oral dose of the study product attenuates nasal provocation and other allergy-related symptoms after exposure to a standardized allergenic challenge as compared to placebo. Healthy subjects were recruited to participate in a randomized, double-blind, two-arm crossover, placebo-controlled, clinical trial. One acute dose of either the active study product (proprietary blend of quail egg) or placebo was given concomitantly to the standardized allergenic challenge. The primary endpoint was peak nasal inspiratory flow (PNIF) measurement and the secondary endpoints were subjects' perceived feelings of well-being based on Visual Analog Scale (VAS) scores for allergy-related symptoms, as well as immunoglobulin E count. Forty-three healthy subjects were enrolled and evaluable in a per protocol analysis. A gradual increase in PNIF from nadir up to Time 120 reflected the normal, gradual recovery from nasal obstruction induced by allergenic challenge for both the active and the placebo groups. At all postchallenge time points, the active group had higher PNIF values compared to the placebo group, indicating that the active product was associated with fewer symptoms and reduced intensity of these symptoms. The active product resulted also in statistically significant improvements of most of the subjects' perceived feelings of well-being based on VAS scores. No adverse events occurred during the study. In conclusion, the dietary supplement consisting of proprietary blend made of quail eggs provides fast and efficient relief of allergic rhinitis symptoms caused by the most common outdoor and indoor allergens, without adverse events.
机译:摘要由暴露于污染或过敏原引起的偶发性鼻炎症状日益引起人们的关注。首先基于对鹌鹑养殖户过敏发生率较低的经验观察,然后根据卵类粘液特性进行科学研究,我们开发了膳食补充剂来缓解这种偶尔的鼻炎症状。这项研究的目的是确定与口服安慰剂相比,口服标准剂量的研究产品后,是否能减轻鼻腔激怒和其他与过敏有关的症状。健康受试者被招募参加一项随机,双盲,两臂交叉,安慰剂对照的临床试验。给予标准化研究的致敏性挑战的一剂急性剂量的活性研究产品(鹌鹑蛋专有混合物)或安慰剂。主要终点是鼻吸气峰值(PNIF)测量,次要终点是基于过敏相关症状的视觉模拟量表(VAS)得分以及免疫球蛋白E计数的受试者感觉到的幸福感。根据方案分析,招募了43位健康受试者并对其进行了评估。从最低点到时间120 PNIF逐渐增加,反映了活性组和安慰剂组从变应原性刺激诱发的鼻阻塞正常,逐渐恢复。在所有激发后的时间点,活性组的PNIF值均高于安慰剂组,这表明活性产物与较少的症状相关,并且这些症状的强度降低。活性产品还可以根据VAS分数在统计学上显着改善大多数受试者的幸福感。研究期间未发生不良事件。总之,由鹌鹑蛋制成的专有混合物组成的膳食补充剂可快速有效地缓解由最常见的室外和室内过敏原引起的过敏性鼻炎症状,而不会产生不良事件。

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