Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Severe chronic obstructive pulmonary disease (COPD) patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 793
Healthy volunteers: no

Brief summary:
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms:
arm 1: Add-on treatment arm 2: Add-on treatment

Interventions: intervention 1: Budesonide/formoterol (Symbicort® Turbuhaler®) intervention 2: Tiotropium (SpirivaTM)
Intervention descriptions: intervention 1: Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily intervention 2: Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily

Protocol document: