NCT00869596已完成1 期
A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Sputum percent neutrophils
研究概览
简要总结
This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
- •Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
- •Subject is a nonsmoker
- •Subject is in generally good health
- •Subject is willing to comply with the diet, alcohol, and caffeine study restrictions
排除标准
- •Subject is a nursing mother
- •Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
- •Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
- •Subject has a recent history of allergic rhinitis at screening
- •Subject has any respiratory disease at screening
- •Subject has daily phlegm or a chronic cough
- •Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study
- •Subject consumes excessive amounts of alcohol or caffeine
- •Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening
- •Subject has a history of stroke, seizures, or major neurological disorders
- •Subject regularly uses illicit drugs or has a history of drug/alcohol abuse
- •Subject received a vaccination within 3 weeks of screening
研究组 & 干预措施
2
Active Comparator
Fluticasone 440 mcg
干预措施: fluticasone propionate (Drug)
3
Active Comparator
Fluticasone 1980 mcg
干预措施: fluticasone propionate (Drug)
结局指标
主要结局
Sputum percent neutrophils
时间窗: 6 hours following inhaled LPS challenge
次要结局
- Sputum absolute neutrophils (per mL)(6 hours following inhaled LPS challenge)
- Sputum levels of IL1beta and IL8(6 hours following inhaled LPS challenge)
- Sputum mRNA expression levels of CD14 and IL1beta(6 hours following inhaled LPS challenge)
研究者
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