A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multi Center Study to Assess the Safety and Efficacy of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) Subjects Recovering From Hospitalization for an Acute Exacerbation (Hospital Discharge Study 2)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 50
- 主要终点
- Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).
研究概览
简要总结
A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 2)
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
研究组 & 干预措施
18 mcg tiotropium bromide
Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
干预措施: tiotropium bromide (Drug)
placebo
Patient to receive one placebo inhalation powder capsule daily (in the morning) via HandiHaler
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).
时间窗: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
Percentage (number) of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality. Time to the next adverse clinical outcome event from the Two Twin Trials, present 205.478 (NCT01662986) and 205.477 (NCT01663987) was not analysed, only Kaplan Meier curve was plotted. So this endpoint has not been disclosed. This endpoint was analysed using combined data, as specified in the analysis plan
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug.
时间窗: Baseline and 12 weeks
Change from baseline of trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study drug. Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.
次要结局
- Percentage of Patients With Adverse Clinical Event During on Study.(from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years)
- Percentage of Patients With 30-day Hospital Readmission Rates Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(from date of hospital discharge prior to randomization upto readmission days >1 and <31 days)
- Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(Baseline and week 12)
- Change From Baseline of Trough FVC at 12 Weeks on Study Drug.(baseline and 12 weeks)
- Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(Baseline and week 12)
- Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years)
- Exposure of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years)
- Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(from first drug administration to the last timepoint with information of EXACT-PRO, Up to 2 years)
- Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years)
- Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).(from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years)
- Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years)
- Exposure of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)(from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years)