A Double Blind, Crossover Placebo-controlled Study to Evaluate the Effect of L-arginine and Aminoguanidine on Bronchial and Alveolar Nitric Oxide and Nitric Oxide Metabolites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bronchial exhale nitric oxide (JNO)
研究概览
简要总结
The primary aim of this study is to investigate the effects of oral and inhaled administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with COPD.
详细描述
Nitric oxide (NO) is produced by resident and inflammatory cells in the respiratory tract by the enzyme NO synthase (NOS), which exists in three isoforms: neuronal NOS (nNOS), inducible NOS (iNOS), and endothelial NOS. NO production is increased in patients with COPD, and the production of NO under oxidative stress conditions generates reactive nitrogen species that may amplify the inflammatory response in COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smokers
- •Normal spirometry (FEV1 >90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s)
- •At risk (current smokers)
- •Normal spirometry, with or without chronic symptoms (cough, sputum production)
- •FEV1 reversibility of <15% after inhaled beta2-agonists*
- •Moderate COPD
- •FEV1 greater than or equal to 30% and < 80%
- •FEV1/FVC < 70% predicted
- •FEV1 reversibility of <15% after inhaled beta2-agonists
- •With or without chronic symptoms (cough, sputum production, dyspnea)
- •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
研究组 & 干预措施
Chronic Obstructive Pulmonary Disease COPD
COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
干预措施: Placebos (Drug)
Healthy volunteers non smoker
Control group
干预措施: Aminoguanidine (Drug)
Healthy volunteers non smoker
Control group
干预措施: Placebos (Drug)
Healthy volunteers smoker
More than 10 pack-years
干预措施: Aminoguanidine (Drug)
Healthy volunteers smoker
More than 10 pack-years
干预措施: Placebos (Drug)
Chronic Obstructive Pulmonary Disease COPD
COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
干预措施: Aminoguanidine (Drug)
结局指标
主要结局
Bronchial exhale nitric oxide (JNO)
时间窗: 24 hours
Bronchial exhale nitric oxide (JNO) as assessed by Chemo luminescence
次要结局
未报告次要终点