CLINICAL TRIAL: PHASE 1 STUDY OF DERMATOPHAGOIDES FARINAE INHALATION IN HUMANS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这将是一项关于吸入粉尘变应原提取物(粉尘螨或粉尘螨)对15名轻度过敏性哮喘受试者呼吸道反应的非盲法研究。主要终点将是FEV1比基线测量(在紧接之前获得)减少15% 挑战)在吸入一系列递增的过敏原中的一种后的10分钟内。这些剂量将以5次吸入过敏原的方式递送，同时增加吸入D粉尘变应原提取物的浓度。 痰样本将在挑战后24小时与基线样本进行分析和比较。在过敏原激发后4小时，我们将通过伽马闪烁成像测量吸入的放射性标记颗粒的粘液纤毛清除(MCC)作为探索性终点。预计粘液纤毛清除将被抑制，作为对变应原挑战的后期反应的一部分。将与本议定书基线访问期间从同一受试者获得的MCC进行比较。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This will be a non-blinded study of the effect of inhaled dust mite allergen extract (Dermatophagoides Farinae or D Farinae ) on airway responses in 15 mild allergic asthmatic subjects. The principal endpoint will be a decrease in FEV1 of 15% from baseline measurements (obtained immediately prior to challenge) within 10 minutes after inhalation of one of a series of increasing allergen doses. The doses will delivered as 5 inhalations of allergen at increasing concentrations of inhaled D Farinae allergen extract. Sputum samples will be analyzed and compared at 24 hours post challenge versus the baseline sample. At 4 hours post allergen challenge, we will measure mucociliary clearance (MCC) of inhaled, radiolabeled particles by gamma scintigraphy as an exploratory endpoint. It is expected that mucociliary clearance will be depressed as part of a late phase reaction to allergen challenge. Comparisons will be made with MCC obtained from the same subject during the baseline visit for this protocol.