PDF(Pubmed)
Abstract：
UNASSIGNED: Pollen variation can affect field study data quality. Nasal allergen challenge (NAC) is considered the gold standard for evaluating allergic rhinitis, while environmental exposure chambers (EECs) are mainly used in phase 2 drug development studies. We aimed to study birch-induced allergic rhinitis under 3 different conditions.
UNASSIGNED: This study included 30 participants allergic to birch pollen, based on birch skin prick test, specific immunoglobulin E (IgE), and positive NAC. Participants were exposed to placebo twice, followed by 2 consecutive 4-h birch airborne exposures, repeated on 2 occasions to evaluate reproducibility and priming effect. Nasal response was defined as total corrected nasal symptom score (ΔTNSS) ≥ 5 during NAC and EEC. The primary end-point was to measure TNSS during the last 2 h of first allergen exposure. TNSS was also analyzed during natural exposure.
UNASSIGNED: The dose most commonly yielding positive TNSS during NAC was 175.2 ng/200 μL. Eighteen participants experienced ΔTNSS ≥5 during the last 2 h of the first exposure, whereas 21 had positive responses at all 4 exposures. Mean ΔTNSS was 1 with placebo versus 6 with birch. Exposures were reproducible, with no observed priming effect. Airborne Bet v 1 was 25 ng/m3, while the pollen measurement was 279/m3 during pollen season. TNSS reached 5 in 67.9% of participants during peak pollen season.
UNASSIGNED: EEC outcomes were similar to those obtained with NAC and natural exposure, suggesting the usefulness of EEC in allergic rhinitis studies. The primary end-point was reached, as 60% of participants experienced nasal responses.
UNASSIGNED: This study included 30 participants allergic to birch pollen, based on birch skin prick test, specific immunoglobulin E (IgE), and positive NAC. Participants were exposed to placebo twice, followed by 2 consecutive 4-h birch airborne exposures, repeated on 2 occasions to evaluate reproducibility and priming effect. Nasal response was defined as total corrected nasal symptom score (ΔTNSS) ≥ 5 during NAC and EEC. The primary end-point was to measure TNSS during the last 2 h of first allergen exposure. TNSS was also analyzed during natural exposure.
UNASSIGNED: The dose most commonly yielding positive TNSS during NAC was 175.2 ng/200 μL. Eighteen participants experienced ΔTNSS ≥5 during the last 2 h of the first exposure, whereas 21 had positive responses at all 4 exposures. Mean ΔTNSS was 1 with placebo versus 6 with birch. Exposures were reproducible, with no observed priming effect. Airborne Bet v 1 was 25 ng/m3, while the pollen measurement was 279/m3 during pollen season. TNSS reached 5 in 67.9% of participants during peak pollen season.
UNASSIGNED: EEC outcomes were similar to those obtained with NAC and natural exposure, suggesting the usefulness of EEC in allergic rhinitis studies. The primary end-point was reached, as 60% of participants experienced nasal responses.
摘要：
■花粉变异会影响野外研究数据质量。鼻过敏原攻击（NAC）被认为是评估过敏性鼻炎的金标准，而环境暴露室（EEC）主要用于第二阶段药物开发研究。我们旨在研究3种不同条件下桦树诱导的过敏性鼻炎。
■这项研究包括30名对桦树花粉过敏的参与者，根据桦树皮穿刺试验,特异性免疫球蛋白E（IgE），和积极的NAC。参与者两次接触安慰剂，随后是2次连续4小时的桦树空气暴露，重复2次，以评估重现性和启动效果。鼻反应定义为NAC和EEC期间的总矫正鼻症状评分（ΔTNSS）≥5。主要终点是在首次过敏原暴露的最后2小时内测量TNSS。在自然暴露期间还分析了TNSS。
■在NAC期间最常产生阳性TNSS的剂量为175.2ng/200μL。18名参与者在第一次暴露的最后2小时内经历了ΔTNSS≥5，而21在所有4次暴露中均有阳性反应。安慰剂的平均ΔTNSS为1，桦木的平均ΔTNSS为6。暴露是可重复的，没有观察到的启动效应。机载Betv1为25ng/m3，而花粉季节的花粉测量值为279/m3。在花粉高峰季节，TNSS达到67.9％的参与者中的5。
■EEC结果与使用NAC和自然暴露获得的结果相似，提示EEC在过敏性鼻炎研究中的有用性。达到主要终点,60%的参与者经历了鼻腔反应。
■这项研究包括30名对桦树花粉过敏的参与者，根据桦树皮穿刺试验,特异性免疫球蛋白E（IgE），和积极的NAC。参与者两次接触安慰剂，随后是2次连续4小时的桦树空气暴露，重复2次，以评估重现性和启动效果。鼻反应定义为NAC和EEC期间的总矫正鼻症状评分（ΔTNSS）≥5。主要终点是在首次过敏原暴露的最后2小时内测量TNSS。在自然暴露期间还分析了TNSS。
■在NAC期间最常产生阳性TNSS的剂量为175.2ng/200μL。18名参与者在第一次暴露的最后2小时内经历了ΔTNSS≥5，而21在所有4次暴露中均有阳性反应。安慰剂的平均ΔTNSS为1，桦木的平均ΔTNSS为6。暴露是可重复的，没有观察到的启动效应。机载Betv1为25ng/m3，而花粉季节的花粉测量值为279/m3。在花粉高峰季节，TNSS达到67.9％的参与者中的5。
■EEC结果与使用NAC和自然暴露获得的结果相似，提示EEC在过敏性鼻炎研究中的有用性。达到主要终点,60%的参与者经历了鼻腔反应。
