Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 813
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with 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

Interventions: intervention 1: tiotropium intervention 2: placebo intervention 3: olodaterol intervention 4: tiotropium intervention 5: tiotropium intervention 6: olodaterol
Intervention descriptions: intervention 1: fixed dose combination intervention 2: None intervention 3: fixed dose combination intervention 4: fixed dose combination intervention 5: None intervention 6: fixed dose combination

Protocol document: