Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 291
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 olodaterol 5 mcg once daily arm 2: placebo comparator for tiotropium + olodaterol arm 3: patient will receive tiotropium 5 mcg once daily arm 4: patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily arm 5: patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily

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

Protocol document: