NCT01714427已完成不适用
Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The effects of LPS instillation on a putative microvascular leak formation in a lung subsegment by radiologic imaging (magnetic resonance imaging, computed tomography) will be quantified.
研究概览
简要总结
The purpose of this study is to investigate the local and systemic inflammatory response and haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to determine the feasibility of imaging techniques to quantify lung inflammation in an adapted human endotoxin instillation model.
The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).
- •Nonsmoker
- •Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- •If female and of childbearing potential and subjects agrees to employ adequate birth control measures (e. g. oral contraceptives, barrier method)
- •Negative urine pregnancy test
排除标准
- •Known or suspected allergy to trial product or related products
- •Pregnancy or Lactation
- •Treatment with an investigational drug within three weeks prior to this trial
- •Participation in an LPS trial within the last 6 weeks
- •History of relevant cardiac arrhythmia
- •Preexisting open or closed angle glaucoma
- •History of Osteoporosis, Cushing´s syndrome, gastro-duodenal ulcera, cardiovascular disease, vasculitis, diabetes mellitus, hypertension, brain tumor or history of neurosurgery
- •Systemic tuberculosis
- •Hemorrhagic diathesis
- •Relevant liver or kidney dysfunction
- •Regular use of medication or abuse of alcohol unless considered clinically relevant
- •Use of any medication within one week prior to the first trial day
- •Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
- •Excessive sporting activities
- •Subjects on Monoamine oxidase inhibitors (should be stopped for at least two to three weeks before dihydrocodeine treatment is initiate)
- •Known acute or active hepatic disease within the past 3 months
- •A platelet count < 100,000 x 106/L, prothrombin time > 1.5, liver enzymes> 3 times the upper normal limit
- •Having received a vaccination up to 8 weeks before the trial
研究组 & 干预措施
Dexamethasone
Active Comparator
干预措施: Dexamethasone (Drug)
Sterile isotonic saline
Placebo Comparator
干预措施: Sterile isotonic saline (Drug)
结局指标
主要结局
The effects of LPS instillation on a putative microvascular leak formation in a lung subsegment by radiologic imaging (magnetic resonance imaging, computed tomography) will be quantified.
时间窗: 6/24 hours after LPS Instillation
次要结局
未报告次要终点
研究者
Bernd Jilma
Associate Professor of Clinical Pharmacology & Internal Medicine
Medical University of Vienna
研究点 (1)
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