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)
Overview
- Phase
- Phase 4
- Intervention
- tiotropium bromide
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 79
- Locations
- 50
- Primary Endpoint
- Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug
- 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 1)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
18 mcg tiotropium
Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Intervention: tiotropium bromide
Placebo
Patient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)