Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 229
Healthy volunteers: no

Brief summary:
The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® after 6 weeks of treatment.

Detailed description:

Arms:
arm 1: Low dose arm 2: High dose arm 3: Low dose arm 4: High dose

Interventions: intervention 1: fluticasone propionate intervention 2: salmeterol intervention 3: placebo intervention 4: placebo intervention 5: tiotropium intervention 6: olodaterol intervention 7: olodaterol intervention 8: placebo intervention 9: placebo intervention 10: tiotropium intervention 11: fluticasone propionate intervention 12: salmeterol
Intervention descriptions: intervention 1: low dose intervention 2: None intervention 3: placebo/dummy for blinding purposes intervention 4: placebo/dummy for blinding purposes intervention 5: tiotropium high dose intervention 6: None intervention 7: None intervention 8: placebo/dummy for blinding purposes intervention 9: placebo/dummy for blinding purposes intervention 10: tiotropium low dose intervention 11: low dose intervention 12: None

Protocol document: