A Randomised, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed-dose Combination (2.5µg / 5µg, 5µg / 5µg ) and Olodaterol (5 µg) Delivered by the RESPIMAT Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Phase 3
- Intervention
- Tiotropium + Olodaterol
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 122
- Locations
- 24
- Primary Endpoint
- Number (%) of Patients With Drug-related AEs
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Tiotropium + Olodaterol (high dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Intervention: Tiotropium + Olodaterol
Tiotropium + Olodaterol (high dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Intervention: Respimat
Olodaterol
Olodaterol solution for inhalation - RESPIMAT
Intervention: Olodaterol
Olodaterol
Olodaterol solution for inhalation - RESPIMAT
Intervention: Respimat
Tiotropium + Olodaterol (low dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Intervention: Tiotropium + Olodaterol
Tiotropium + Olodaterol (low dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Intervention: Respimat
Outcomes
Primary Outcomes
Number (%) of Patients With Drug-related AEs
Time Frame: From first drug administration until 21 days after the last administration, upto 392 days
Number (%) of patients with drug-related Adverse Events (AEs).
Secondary Outcomes
- FEV1 AUC0-3h Response(Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks)
- Trough FEV1 Response(Baseline and 1 h, 10 min pre-dose after 52 weeks)