NCT00159289撤回不适用
Effect of Endotoxin on Inflammatory Markers in Exhaled Breath, Sputum, Saliva and Nasal Lavage in Healthy Non-Smokers and Current Smokers Including Patients With COPD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- sputum induced
研究概览
简要总结
The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second [FEV1] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s)
- •0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production)
- •I-II: Mild-moderate COPD
- •FEV1 reversibility of < 15% after inhaled beta2-agonists
- •FEV1/forced vital capacity (FVC) < 70% predicted
- •FEV1 between greater than or equal to 50% and less than 80%
- •With or without chronic symptoms (cough, sputum production)
- •Able to comprehend and grant a written informed consent
排除标准
- •Concomitant use or pre-treatment within the last 4 weeks with oral steroids
- •Respiratory infection within 4 weeks prior to entry into the trial
- •Females who are pregnant or lactating
- •History of current or past drug or alcohol abuse
结局指标
主要结局
sputum induced
次要结局
未报告次要终点
研究者
研究点 (2)
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