Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 219
Healthy volunteers: no

Brief summary:
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

Detailed description:

Arms:
arm 1: tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing) arm 2: tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing) arm 3: tiotropium low dose; 2 inhalations once daily (a.m. dosing) arm 4: tiotropium high dose; 2 inhalations once daily (a.m. dosing) arm 5: one dose only; 2 inhalations once daily (a.m. dosing) arm 6: 2 inhalations once daily (a.m. dosing)

Interventions: intervention 1: tiotropium + olodaterol intervention 2: tiotropium intervention 3: olodaterol intervention 4: tiotropium intervention 5: tiotropium + olodaterol intervention 6: Placebo intervention 7: Respimat
Intervention descriptions: intervention 1: low dose + one dose only intervention 2: low dose intervention 3: one dose only intervention 4: high dose intervention 5: low dose + one dose only intervention 6: placebo matching tiotropium+olodaterol FDC intervention 7: Respimat inhaler

Protocol document: