NCT00274547已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,829
- 试验地点
- 26
- 主要终点
- Percentage of patients experiencing an exacerbation
研究概览
简要总结
The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.
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
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of patients experiencing an exacerbation
时间窗: 6 months
Percentage of patients hospitalized for a COPD exacerbation
时间窗: 6 months
次要结局
- Number of unscheduled out-patient visits(6 months)
- Time to first COPD exacerbation(6 months)
- Total number of days of corticosteroids for an COPD exacerbation(6 months)
- Total number of hospital admissions and total hospital days(6 months)
- Time to first hospitalization associated with an COPD exacerbation(6 months)
- Total number of antibiotics for an COPD exacerbation(6 months)
- Trough post-dose FEV1 and FVC(after 3 and 6 months)
- 90 minute post-dose FEV1 and FVC(after 3 and 6 months)
- Occurrence of serious adverse events(6 months)
研究者
研究点 (26)
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