Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 295
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD

Detailed description:

Arms:
arm 1: patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily arm 2: patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily arm 3: patient will receive tiotropium 5 mcg once daily arm 4: patient will receive olodaterol 5 mcg once daily arm 5: None

Interventions: intervention 1: Placebo intervention 2: Tiotropium intervention 3: Olodaterol intervention 4: tiotropium + olodaterol intervention 5: Tiotropium + Olodaterol intervention 6: Respimat
Intervention descriptions: intervention 1: placebo matching tiotropium + olodaterol FDC intervention 2: Tiotropium 5 mcg once daily intervention 3: Olodaterol 5 mcg once daily intervention 4: tiotropium + olodaterol 5 mcg once daily intervention 5: Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily intervention 6: Respimat inhaler

Protocol document: