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

临床试验：人类吸入粉尘螨的第一阶段研究

• 批准号: 7716893
• 负责人: David B. Peden
• 金额: $ 0.18万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716893
• 关键词: Allergens; Allergic; Breathing; Computer Retrieval of Information on Scientific Projects Database; Depressed mood; Dermatophagoides farinae; Dose; End Point; Funding; Gamma Particles; Grant; Hour; Human; Institution; Measurement; Measures; Mucociliary Clearance; Phase; Phase I Clinical Trials; Protocols documentation; Pulmonary Function Test/Forced Expiratory Volume 1; Radiolabeled; Radionuclide Imaging; Reaction; Research; Research Personnel; Resources; Sampling; Series; Source; Sputum; United States National Institutes of Health; Visit; pyroglyphid; radiotracer; response

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.

这个子项目是众多研究子项目之一