Study identifier:D589BL00023
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A randomised, parallel-group, open-label, multicentre, 3-month phase IV, efficacy and tolerability study of budesonide/formoterol (Symbicort® Turbuhaler® 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (SpirivaTM 18 μg/inhalation, 1 inhalation once daily) compared with tiotropium (SpirivaTM18 μg/inhalation, 1 inhalation once daily) alone in severe chronic obstructive pulmonary disease (COPD) patients
Chronic obstructive pulmonary disease (COPD)
Phase 4
No
Budesonide/formoterol (Symbicort® Turbuhaler®), Tiotropium (SpirivaTM)
All
793
Interventional
40 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Other: 1 Add-on treatment | Drug: Budesonide/formoterol (Symbicort® Turbuhaler®) Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily Drug: Tiotropium (SpirivaTM) Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily |
Other: 2 Add-on treatment | Drug: Tiotropium (SpirivaTM) Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily |