Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

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).

Detailed description:

Arms:
arm 1: Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT arm 2: Olodaterol solution for inhalation - RESPIMAT arm 3: Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Interventions: intervention 1: Tiotropium + Olodaterol intervention 2: Respimat intervention 3: Tiotropium + Olodaterol intervention 4: Olodaterol intervention 5: Respimat intervention 6: Respimat
Intervention descriptions: intervention 1: Tiotropium and Olodaterol FDC once daily inhalation intervention 2: Respimat inhaler intervention 3: Tiotropium and Olodaterol FDC once daily inhalation intervention 4: Olodaterol once daily inhalation intervention 5: Respimat inhaler intervention 6: Respimat inhaler

Protocol document: