NCT01364519已完成1 期
A Randomized, Double-Blind (3rd Party Open), Placebo-Controlled, 2-Way Crossover Study To Determine The Effects Of A Single Inhaled Dose Of 500 MCG Fluticasone Propionate On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Sputum Neutrophil (%)
研究概览
简要总结
Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.
详细描述
Methodology Validation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Normoresponsive airways - histamine PC20>16mg/mL
- •Able to complete sputum induction successfully
排除标准
- •Non (or ex) smokers
- •No LPS challenge in previous 4 weeks
研究组 & 干预措施
Arm 1
Experimental
干预措施: Fluticasone Propionate (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo for Fluticasone Propionate (Drug)
结局指标
主要结局
Sputum Neutrophil (%)
时间窗: 6 hours post LPS challenge
次要结局
- Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta)(6 hours post LPS challenge)
- Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta)(1, 4 and 6 hours post LPS challenge)
- Sputum cells (macrophages and total cell count)(6 hours post LPS challenge)
研究者
研究点 (1)
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