Study identifier:D5122C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A 12-week, randomised, double-blind, placebo-controlled, parallel-group, multi-national, phase III, efficacy and safety study of inhaled formoterol 4.5 μg and 9 μg twice daily in Japanese and European patients with chronic obstructive pulmonary disease (COPD)
Chronic Obstructive Pulmonary Disease
Phase 3
No
Formoterol Turbuhaler® 4.5mg, Formoterol Turbuhaler® 9 mg, Turbuhaler® placebo
All
613
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: F 4.5 bid Formoterol 4.5 ug twice daily (bid) | Drug: Formoterol Turbuhaler® 4.5mg 4.5 mg inhaled twice daily Other Name: Oxis |
Experimental: F 9.0 bid Formoterol 9.0 ug bid | Drug: Formoterol Turbuhaler® 9 mg 9 mg inhaled twice daily Other Name: Oxis |
Placebo Comparator: PBO Placebo | Drug: Turbuhaler® placebo placebo inhaled twice daily |