Conditions: Chronic Obstructive Pulmonary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: no

Brief summary:
To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

Detailed description:

Arms:
arm 1: Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study. arm 2: Fixed combination of fluticasone and salmeterol

Interventions: intervention 1: Budesonide intervention 2: Fluticasone intervention 3: Indacaterol intervention 4: Salmeterol
Intervention descriptions: intervention 1: Budesonide 400 mcg twice a day via Breezhaler® device intervention 2: Fluticasone 250 mcg twice daily via Accuhaler® device intervention 3: Indacaterol 150 mcg once daily via Breezhaler® device intervention 4: Salmeterol 50 mcg twice daily via Diskus® device

Protocol document: