NCT00106821已完成4 期
An 8 Week Randomized, Placebo Controlled, Double-blind Study to Assess the Efficacy of Tiotropium Inhalation Capsules in Patients of African Descent With Chronic Obstructive Pulmonary Disease
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 22
- 主要终点
- The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
研究概览
简要总结
The purpose of this study is to look at the benefits of tiotropium, an approved drug for the treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a population of patients with COPD who are of African American descent.
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
- •Male or female of African descent
- •40 years of age or older
- •Diagnosis of COPD
- •History of smoking at least one pack per day for at least 10 years
- •Currently experiencing shortness of breath at least with exertion
排除标准
- •Recent myocardial infarction or hospitalization for congestive heart failure
结局指标
主要结局
The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
次要结局
- FEV1 AUC0-3 after single dose, 4 weeks of treatment, peak FEV1 on each test day, trough FEV1 at weeks 4 & 8, FVC trough (weeks 4 & 8), peak and AUC(0-3) (on all test days), FEV1 and FVC at all time points, rescue albuterol use, dyspnea SOP questionnaire
研究者
研究点 (22)
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