Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 809
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: olodaterol intervention 2: tiotropium intervention 3: placebo
Intervention descriptions: intervention 1: fixed dose combination intervention 2: fixed dose combination intervention 3: None

Protocol document: