NCT00259779已完成3 期
A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exacerbation, Followed by Twelve Weeks Open Follow up Period With Budesonide/Formoterol (Symbicort Forte Turbuhaler)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 37
- 主要终点
- Forced Expiratory Volume in one second (FEV1)
研究概览
简要总结
To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
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
- •Patients with chronic obstructive pulmonary disease and an acute exacerbation
- •After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value.
- •Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease
排除标准
- •Diagnosis/history of asthma
- •Oxygen uptake (saturation) is <92% after the initial acute treatment
- •A requirement for regular use of oxygen therapy
- •Regular treatment with any inhaled steroid >1 000 µg/day at study entry
- •Additional inclusion and exclusion criteria will be evaluated by the investigator
结局指标
主要结局
Forced Expiratory Volume in one second (FEV1)
次要结局
- Number of patients with treatment failures
- Time to first exacerbation
- Number of patients developing an exacerbation
- Diary cards
- Quality of Life
- - Adverse Events (AEs)
- Serious Adverse Events (SAEs) and Discontinuations due to AEs
- Variables will be assessed before and over the 2+12 weeks treatment period
研究者
研究点 (37)
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