Krug N, Hohlfeld J M, Larbig M, Buckendahl A, Badorrek P, Geldmacher H, Behnke W, Dunkhorst W, Windt H, Loedding B, Luettig B, Koch W
Fraunhofer Institute of Toxicology and Experimental Medicine, Hannover, Germany.
Clin Exp Allergy. 2003 Dec;33(12):1667-74. doi: 10.1111/j.1365-2222.2003.01810.x.
There is an increasing need for allergen inhalation systems to perform basic clinical research and test anti-allergic drugs under well-controlled conditions. This requires stability of environmental conditions like temperature and humidity, as well as allergen concentration and reproducible induction of allergic symptoms.
The aim of this study was to validate an environmental exposure unit for controlled human pollen inhalation studies in participants with seasonal allergic rhinitis.
Temperature, relative humidity, and air flow rate were kept constant with an air conditioning system. Pollen atmosphere was generated using a specially designed feeding system and monitored online by laser counter and offline using rotating rod samplers. Efficacy (total nasal symptom score, nasal air flow rate, nasal secretion) and safety (lung function) parameters were evaluated at different pollen concentrations and repeated allergen challenges.
Temperature, humidity, and air flow rate in the environmental exposure unit remained constant within a range of <2%. The spatial distribution and the temporal stability of the pollen concentration varied only slightly over 4 h (+/-10% and <4%, respectively). Dose-dependent induction of allergic rhinitis symptoms, reduction in nasal air flow rate, and increase in nasal secretion were observed over time. These effects were reproducible from day to day. Lung function remained clinically normal at all concentrations and from day to day.
Thus, pollen exposure in the environmental exposure unit is an effective, reproducible, safe, and suitable method for single-centre clinical studies on the efficacy of anti-allergic treatment or basic clinical research.
在严格控制的条件下进行基础临床研究和测试抗过敏药物，对过敏原吸入系统的需求日益增加。这需要温度和湿度等环境条件的稳定性，以及过敏原浓度和过敏症状的可重复诱导。
本研究的目的是验证一种环境暴露装置，用于对季节性过敏性鼻炎患者进行可控的人体花粉吸入研究。
使用空调系统使温度、相对湿度和空气流速保持恒定。使用专门设计的输送系统产生花粉环境，并通过激光计数器进行在线监测，使用旋转棒采样器进行离线监测。在不同花粉浓度和重复过敏原激发下，评估疗效（总鼻症状评分、鼻气流速率、鼻分泌物）和安全性（肺功能）参数。
环境暴露装置中的温度、湿度和空气流速在<2%的范围内保持恒定。花粉浓度的空间分布和时间稳定性在4小时内仅略有变化（分别为±10%和<4%）。随着时间的推移，观察到过敏性鼻炎症状的剂量依赖性诱导、鼻气流速率降低和鼻分泌物增加。这些效应每天都可重复。在所有浓度下，肺功能每天都保持临床正常。
因此，环境暴露装置中的花粉暴露是一种有效、可重复、安全且适合用于抗过敏治疗疗效单中心临床研究或基础临床研究的方法。
