A Comparison of 18 μg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 μg, 4 Times Daily) 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
- 141
- 试验地点
- 36
- 主要终点
- Trough FEV1 response: change from baseline FEV1 (visit 2) to visit 4 trough FEV1
研究概览
简要总结
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD).
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).
详细描述
This is a 2-treatment, randomized, double-blind, parallel design trial in adult patient with COPD.
Each dose of tiotropium or placebo will consist of one capsule self administered from the HandiHaler device once daily during the treatment period (tiotropium or placebo). Each dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.
Each dose of ipratropium MDI or placebo MDI will consist of 2 puffs; patients will inhale 2 puffs four times daily. The first dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.; subsequent doses will be taken at lunch, at dinner and when going to bed.
Study Hypothesis:
The null hypothesis is that there is no difference in mean response between tiotropium and ipratropium.
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
Trough FEV1 response: change from baseline FEV1 (visit 2) to visit 4 trough FEV1
时间窗: 4 weeks
次要结局
- All adverse events(4 weeks)
- Daily PEFR(4 weeks)
- Vital signs (pulse rate and blood pressure)(4 weeks)
- FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration(4 weeks)
- Trough FVC response(4 weeks)
- FVC (AUC0-3) response (as defined for FEV1)(4 weeks)
- Patient questionnaire(4 weeks)
- Amount of rescue medication(4 weeks)
- Number of patients with abnormalities in routine blood chemistry, haematology and urinanalysis(4 weeks)
- Changes from baseline in 12-lead electrocardiogram (ECG)(4 weeks)
- Physical examination(4 weeks)