Spiriva Assessment of FEV1 - (SAFE-Portugal). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Treatment in Patients With COPD. A Three-month Parallel Group, Double-blind, Randomised, Placebo-controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 66
- 主要终点
- Change in trough FEV1 after 12 weeks of treatment.
研究概览
简要总结
Evaluate whether the effect of inhaled tiotropium bromide on the change in trough forced expiratory volume (FEV1), compared to placebo in patients with chronic obstructive pulmonary disease (COPD), is affected by smoking status.
详细描述
Evaluate whether the effect of inhaled tiotropium bromide on the change in trough FEV1 from baseline to week 12 compared to placebo in patients with COPD is affected by smoking status. Secondary objectives include FEV1 at interim visit and FVC at on-treatment visits, use of rescue medication, COPD symptom scores, Physicians Global Evaluation and EQ-5D scores.
Study Hypothesis:
The primary objective of the study is to show superiority of tiotropium against placebo with respect to trough FEV1 at 12 weeks. Then the 5% two-sided hypotheses test is:
H0: Mean trough FEV1 at 12 weeks in tiotropium = Mean trough FEV1 at 12 weeks in placebo H1: Mean trough FEV1 at 12 weeks in tiotropium unequal Mean trough FEV1 at 12 weeks in placebo If the null hypothesis is rejected in favour of the alternative hypothesis (H1) based on all patients, the same hypotheses will be tested in both sub-populations of current and ex-smokers respectively.
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
Change in trough FEV1 after 12 weeks of treatment.
时间窗: week 12
次要结局
- Trough FEV1 at interim visit(week 6)
- Change in FVC at weeks 6 and 12(week 6, week 12)
- Use of rescue medication (daytime and night-time)(12 weeks)
- Assessment of COPD symptoms(week 0, week 6, week 12)
- The Physician's Global Evaluation at Visits 2 and 4(week 0, week 12)
- Pulse Rate(12 weeks)
- Quality of life questionnaire (EQ-5D) at Visits 2 and 4(week 0, week 12)
- Blood Pressure(12 weeks)