Department of Clinical Immunology, Wroclaw Medical University, Wroclaw, Poland.
ALL-MED Medical Research Institute, Wroclaw, Poland.
Clin Exp Allergy. 2024 Jul;54(7):489-499. doi: 10.1111/cea.14482. Epub 2024 Apr 14.
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.
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 (FEV), was used to evaluate safety.
The consistency of the test was proved by the stability of environmental conditions, including temperature, humidity and CO levels, as well as constant concentrations of grass pollen at predetermined levels ranging from 1000 to 10,000 particles per cubic meter (p/m). Allergic individuals developed symptoms at concentrations of 3000 p/m 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/m together with a challenge duration of 120 min was found to be optimal.
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.
空气中过敏原浓度的波动经常给评估过敏原免疫疗法（AIT）的疗效带来挑战。过敏原暴露室（AEC）是专门开发的医疗设备，可在受控环境下以定义且一致的浓度使个体暴露于过敏原。该研究的目的是验证豚草花粉激发试验，并评估其在过敏性鼻炎患者 AEC 中的安全性。
在 ALLEC®AEC 中，分散不同浓度的豚草花粉。通过总鼻症状评分（TNSS）、声鼻测量、鼻峰吸气流量（PNIF）和鼻分泌物量来测量过敏症状。通过呼气峰流速（PEFR）和第一秒用力呼气量（FEV）评估肺功能，以评估安全性。
通过环境条件的稳定性，包括温度、湿度和 CO 水平，以及在预定的 1000 至 10000 个/立方米（p/m）范围内恒定浓度的花粉，证明了试验的一致性。在所有测量终点中，所有过敏个体在浓度达到 3000 p/m 及以上时都会出现症状。整个挑战过程中肺功能不受影响。整个测试中都确认了症状的可重复性。发现 8000 p/m 的浓度和 120 分钟的挑战持续时间是最佳的。
该研究表明，ALLEC®豚草花粉暴露室为诱导过敏性鼻炎患者可重复的症状提供了一种可靠且安全的方法。这种方法可有效地应用于过敏诊断和 AIT 期间的临床终点确定。
