Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 404
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.

Detailed description:

Arms:
arm 1: once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat arm 2: once daily 2 puffs, FDC solution for inhalation Respimat arm 3: once daily 2 puffs, solution for inhalation Respimat

Interventions: intervention 1: Respimat inhaler intervention 2: tiotropium+olodaterol (low dose) intervention 3: tiotropium + olodaterol (high dose) intervention 4: Respimat inhaler intervention 5: Respimat inhaler intervention 6: placebo to tiotropium+olodaterol
Intervention descriptions: intervention 1: Respimat inhaler intervention 2: 2.5 µg tiotropium + 5 µg olodaterol intervention 3: 5 µg tiotropium + 5 µg olodaterol intervention 4: Respimat inhaler intervention 5: Respimat inhaler intervention 6: comparator

Protocol document: