背景:空气中过敏原浓度的波动经常对评估“现场”研究中过敏原免疫疗法(AIT)的功效提出挑战。过敏原暴露室(AEC)是专门的医疗设施,旨在使个人在受控环境下以确定且一致的浓度暴露于过敏原。该研究的目的是验证timothy草花粉的激发试验,并评估其在过敏性鼻炎患者的AEC中的安全性。
方法:在ALLEC®AEC中,不同浓度的蒂牧草花粉被分散。过敏性症状通过总鼻症状评分(TNSS)来测量,声学鼻测,峰值鼻吸气流量(PNIF)和鼻排出量。肺功能,通过峰值呼气流速(PEFR)和第一秒用力呼气量(FEV1)评估,用于评估安全性。
结果:环境条件的稳定性证明了测试的一致性,包括温度,湿度和二氧化碳水平,以及草花粉的恒定浓度在每立方米1000至10,000个颗粒(p/m3)的预定水平。过敏个体在3000p/m3及以上的浓度出现症状,在所有测量的端点上。在所有挑战中,肺功能均未受到影响。在整个测试中证实了症状的再现性。发现8000p/m3的浓度以及120分钟的攻击持续时间是最佳的。
结论:该研究表明,ALLEC®草花粉暴露室提供了一种可靠且安全的方法来诱导过敏性鼻炎患者的可重复症状。这种方法可以有效地应用于AIT期间的过敏诊断和临床终点确定。
BACKGROUND: The fluctuation in concentrations of airborne allergens frequently presents a challenge to assessing the efficacy of allergen immunotherapy (AIT) in \'field\' studies. Allergen exposure chambers (AECs) are specialized medical installations developed to expose individuals to allergens at defined and consistent concentrations under a controlled environment. The aim of the study was to validate the provocation test with timothy grass pollen as well as to assess its safety in the AEC in patients with allergic rhinitis.
METHODS: In the ALLEC® AEC, varying concentrations of timothy grass pollen were dispersed. Allergic symptoms were measured by total nasal symptom score (TNSS), acoustic rhinometry, peak nasal inspiratory flow (PNIF) and nasal discharge volume. Lung function, assessed through peak expiratory flow rate (PEFR) and forced expiratory volume in the first second (FEV1), was used to evaluate safety.
RESULTS: The consistency of the test was proved by the stability of environmental conditions, including temperature, humidity and CO2 levels, as well as constant concentrations of grass pollen at predetermined levels ranging from 1000 to 10,000 particles per cubic meter (p/m3). Allergic individuals developed symptoms at concentrations of 3000 p/m3 and above, across all measured endpoints. Lung function was not affected throughout all the challenges. The reproducibility of symptoms was confirmed throughout the tests. The concentration of 8000 p/m3 together with a challenge duration of 120 min was found to be optimal.
CONCLUSIONS: The study demonstrates that the ALLEC® grass pollen exposure chamber provides a reliable and safe method for inducing repeatable symptoms in patients with allergic rhinitis. This approach can be effectively applied for allergy diagnostics and clinical endpoint determination during AIT.