Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 221
Healthy volunteers: no

Brief summary:
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.

Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.

Detailed description:

Arms:
arm 1: Fixed Dose Combination of tiotropium + olodaterol arm 2: None

Interventions: intervention 1: FDC of tiotropium + olodaterol intervention 2: Placebo intervention 3: Tiotropium intervention 4: Olodaterol
Intervention descriptions: intervention 1: Fixed Dose Combination of tiotropium + olodaterol intervention 2: None intervention 3: None intervention 4: None

Protocol document: