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 1)
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
- Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug
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 1)
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
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 capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug
时间窗: Baseline and 12 weeks
Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.
Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
时间窗: From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years
Percentage 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, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead. This endpoint was analysed using combined data, as specified in the analysis plan.
次要结局
- Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)(Baseline and 12 weeks)
- Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)(from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years)
- Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)(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 205.477 (NCT01663987) and 205.478 (NCT01662986)(From first drug administration to the last timepoint with information of EXACT-PRO, up to 2 years)
- Change From Baseline of Trough FVC at 12 Weeks on Study Drug(Baseline and 12 weeks)
- Percentage of Patients With Adverse Clinical Event on Study(From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years)
- Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)(Baseline and 12 weeks)
- Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)(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 Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)(from date of hospital discharge prior to randomization up to readmission days >1 and <31 days)
- Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)(From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years)