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临床试验/NCT00568347
NCT00568347已完成不适用

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

Arthur F Gelb MD1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

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

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

发起方
Arthur F Gelb MD
申办方类型
Indiv
责任方
Sponsor Investigator
主要研究者

Arthur F Gelb MD

Arthur F Gelb MD

Gelb, Arthur F., M.D.

研究点 (1)

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