A Comparison of 18 Mcg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 Mcg) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 11
- 主要终点
- The primary endpoint is trough FEV1 response which is defined as change from baseline FEV1 (visit 2) and trough FEV1 at week 4 (visit 4)
研究概览
简要总结
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
详细描述
This is a randomized, double-blind, double-dummy, parallel group study to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules and Atrovent MDI in patients with chronic obstructive pulmonary disease (COPD).
Following an initial screening visit, patients will enter a 2-week baseline period. Patients who successfully complete this phase will be randomized into the double-blind portion of the study in which they will receive tiotropium once daily (morning) or Atrovent four times daily. Pulmonary function testing will be conducted just prior to the start of therapy at Visit 2 (i.e. randomization visit after completion of the 2-week run-in period) and at 120 minutes post-dosing. Pulmonary function testing will be repeated at the same time intervals at the end of therapy.
Study Hypothesis:
Null and alternative hypotheses The primary objective of this study was addressed by a two-sided test at the 0.05 level of significance of the null hypothesis that, in patients with chronic obstructive pulmonary disease (COPD), the bronchodilator efficacy after one month is no greater on tiotropium inhalation capsules (18mcg once daily) than on ATROVENT MDI (2 puffs of 20 mcg q.i.d.), against the alternative hypothesis that the bronchodilator efficacy is greater on tiotropium inhalation capsules (18 mcg once daily).
Comparison(s):
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The primary endpoint is trough FEV1 response which is defined as change from baseline FEV1 (visit 2) and trough FEV1 at week 4 (visit 4)
次要结局
- FEV1 and FVC response at 2 hours post drug administration at on each pulmonary test day; Trough FVC response; Number of rescue medications; and Change from baseline in total score of patient evaluation questionnaire at week 4 (visit 4).