Evaluation of the Effects of Varying Doses of Inhaled Corticosteroids on Suppression of Total Exhaled, Bronchial, and Alveolar Nitric Oxide as Markers of Endogenous Inflammation in Patients With Moderate-to-severe COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- total exhaled, bronchial, and small airway/alveolar nitric oxide
研究概览
简要总结
To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in stable patients with moderate-to-severe COPD who are current non-smokers and not on oral corticosteroids.
详细描述
Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary end points will include measurements of nitric oxide at varying expiratory flow rates to calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of copd
- •Current non-smoker
- •Not on oral corticosteroids
- •Must be able to use Advair discus or salmeterol discus
排除标准
- •Pregnancy
- •Current smoker
- •On corticosteroids
- •Clinically unstable
研究组 & 干预措施
long acting bronchodilator
salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide
干预措施: Salmeterol (Drug)
bronchodilator/ inhaled corticosteroid
fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
干预措施: fluticasone 250/salmeterol 50 (Drug)
bronchodilator/ inhaled corticosteroid
fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
干预措施: salmeterol and fluticasone propionate (Drug)
C
Fluticasone 100mcg/salmeterol 50mcg
干预措施: fluticasone 100mcg/ salmeterol 50mcg (Drug)
C
Fluticasone 100mcg/salmeterol 50mcg
干预措施: Salmeterol (Drug)
结局指标
主要结局
total exhaled, bronchial, and small airway/alveolar nitric oxide
时间窗: 3 months
次要结局
- lung function(3 months)
研究者
Arthur F Gelb MD
Arthur F Gelb MD
Gelb, Arthur F., M.D.
