A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,903
- 试验地点
- 818
- 主要终点
- Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.
研究概览
简要总结
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
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 (Participant, Investigator)
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
研究组 & 干预措施
tiotropium + olodaterol high dose
Once daily 2 puffs solution for inhalation Respimat
干预措施: olodaterol (Drug)
tiotropium + olodaterol high dose
Once daily 2 puffs solution for inhalation Respimat
干预措施: tiotropium (Drug)
tiotropium
Once daily 2 puffs solution for inhalation Respimat
干预措施: tiotropium (Drug)
结局指标
主要结局
Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.
时间窗: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
次要结局
- Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.(From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days)
- Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.(From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days)
- Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.(From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days)
- Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.(From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days)