Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2624
Healthy volunteers: no

Brief summary:
The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms:
arm 1: Once daily 2 puffs solution for inhalation Respimat arm 2: Once daily 2 puffs solution for inhalation Respimat arm 3: Once daily 2 puffs solution for inhalation Respimat arm 4: Once daily 2 puffs solution for inhalation Respimat arm 5: Once daily 2 puffs solution for inhalation Respimat

Interventions: intervention 1: tiotropium + olodaterol intervention 2: tiotropium intervention 3: olodaterol intervention 4: tiotropium intervention 5: tiotropium + olodaterol intervention 6: Respimat
Intervention descriptions: intervention 1: fixed dose combination intervention 2: low dose intervention 3: one dose only intervention 4: high dose intervention 5: fixed dose combination intervention 6: Respimat inhaler

Protocol document: