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临床试验/NCT03859050
NCT03859050招募中不适用

Alveolar Macrophage Programming Following Endotoxin Exposure

National Jewish Health2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
主要终点
Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated

研究概览

简要总结

The histologic hallmarks of lung inflammation include accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Written, informed consent

排除标准

  • Current or recent illness (past 2 weeks)
  • Presence or prior history of cardiac, pulmonary or systemic disease
  • Bleeding disorder, use of systemic anticoagulants or antiplatelet therapy
  • American Society of Anesthesiology (ASA) class 2 or greater
  • Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants)
  • Use of any inhaled substance, including tobacco, marijuana, e-cigarrettes, cocaine, methamphetamines, or toxic vapors in the past 3 months or greater than 10 pack-year smoking history
  • Alcohol use disorder or greater than 7 drinks/week for women or greater than 14 drinks/week for men in the past 3 months
  • Allergy or prior adverse reaction to lidocaine, midazolam or fentanyl
  • Abnormal spirometry or electrocardiogram at time of screening
  • Pregnant (based on urine pregnancy test) or breast feeding

研究组 & 干预措施

LPS arm

Experimental

干预措施: bronchoscopy with intrabronchial administration of lipopolysaccharide (Other)

结局指标

主要结局

Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated

时间窗: 7 days

Resident and recruited macrophages will be purified using fluorescence activated cell sorting (FACS) and subjected to RNA sequencing.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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