A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Phase 4
- Intervention
- FDC of tiotropium + olodaterol
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 221
- Locations
- 22
- Primary Endpoint
- Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
Intervention: FDC of tiotropium + olodaterol
FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
Intervention: Placebo
Free combination tiotropium + olodaterol
Intervention: Tiotropium
Free combination tiotropium + olodaterol
Intervention: Olodaterol
Outcomes
Primary Outcomes
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
Time Frame: Day 29
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
Secondary Outcomes
- Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment(Day 29)
- Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28(Day 28)