NCT00239278已完成2 期
Effects of High Dose Inhaled Budesonide+ Formoterol Versus Placebo and Oral Prednisolone on Biomarkers of Airway Inflammation in the Treatment of Exacerbations in Non-hospitalised Patients With Mild to Moderate COPD.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
研究概览
简要总结
The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •smoking-induced COPD according to ATS criteria
- •FEV1 <85% of predicted at enrolment and <70% of predicted but > 0.7 Liter at Exacerbation
- •FEV1/IVC ratio <88% of predicted for men and <89% for women
排除标准
- •history of asthma
- •known hypersensitivity to the study drugs
- •serious concomitant diseases
- •pregnancy or lactating
- •abnormal Chest X-ray or blood gasses
结局指标
主要结局
Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
次要结局
- Inflammatory markers in induced sputum, blood/serum and urine
- Lung function tests at clinic
- Diary cards for PEF and symptoms
- Patient Related outcomes
- Questioning for Adverse Events and in blood: routine tests and cortisol
研究者
研究点 (1)
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