A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Treatment failure defined as: death from any cause
研究概览
简要总结
Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller.
The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of 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
- •Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease [GOLD] severity stage II)
- •Smoking history of > 10 pack years
排除标准
- •Signs of severe exacerbation (arterial pH < 7.26 or pCO2 > 9.3 kPa)
- •History of asthma
- •Significant or unstable co-morbidity
- •Participated in another study 4 weeks before admission
- •Previously randomized to this study
- •Findings on chest radiography other than those fitting with signs of COPD
- •Known hypersensitivity to prednisolone
- •Non-compliant
结局指标
主要结局
Treatment failure defined as: death from any cause
admission to the intensive care unit
readmission to the hospital because of COPD
and the necessity to intensify pharmacologic treatment
次要结局
- Changes in forced expiratory volume in 1 second (FEV1)
- St. George's Respiratory Questionnaire (SGRQ) scores
- Clinical COPD Questionnaire (CCQ) scores
- and length of hospital stay