The Role of Inhaled Particle Size on the Inflammatory Response Induced by Endotoxin Inhalation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Absolute neutrophil count in sputum
研究概览
简要总结
The purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as particles of different sizes.
详细描述
Endotoxins are inflammatory substances present in the environment. In man, the inhalation of the lipopolysaccharride moiety (LPS) induces measurable immune responses. With an inhaled single dose of 20 micron, the inflammatory response in man is sub-clinical. During bronchoprovocation tests with allergens, the particle size determines to a large extent the intensity of the response. the response to LPS as a function of particle size is not known and will be studied in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteer, non-smoking or ex-smoker >1mth and <10packs/year
- •normal ECG
- •normal lab values for hematology, ionogram, AST, ALT, alk phosphatases, urea, creatinine and CRP
- •FEV1/forced vital capacity >0.7 and FEV1>80% of predicted value
- •able to produce valid sputum following induction (>=50% viable cells, <50% squamous cells and <60% neutrophils)
- •females must be using contraception
- •written informed consent
排除标准
- •infection within 14 days
- •history of bronchial asthma
- •obstructive respiratory condition with FEV1 <70% of theoretical value
结局指标
主要结局
Absolute neutrophil count in sputum
时间窗: 24hrs after LPS inhalation
次要结局
- Calgranulin A/B(0, 6 and 24hrs after LPS inhalation)
- Safety labs from peripheral blood(At the Screening Visit 1 and the Final Visit 5)
- white blood cells and differential in peripheral blood(0, 6 and 24 hrs after LPS inhalation)
- CC16 in peripheral blood(0, 6 and 24hrs after LPS inhalation)
- CRP in peripheral blood(0, 6 and 24hrs after LPS inhalation)
- Alveolo-capillary diffusion(0, 6 and 24hrs after LPS inhalation)
- 12-lead ECG(Screening Visit 1 and final Visit 5)
- Physical exam(At the Screening Visit 1, at the three Visits with LPS inhalation and at the Final Visit)
- Spirometry (FEV1 and FEV1/FEV)(0, 1, 6 and 24hrs after LPS inhalation)