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)
Overview
- Phase
- Phase 4
- Intervention
- tiotropium bromide
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 79
- Locations
- 50
- Primary Endpoint
- Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
18 mcg tiotropium bromide
Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Intervention: tiotropium bromide
placebo
Patient to receive one placebo inhalation powder capsule daily (in the morning) via HandiHaler
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
- 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)