A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

An Open-label Phase III, Multi-centre 52-week , Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9 Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Inclusion Criteria:

• A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
• Documented COPD symptoms for more than 2 years
• Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC<70%

Exclusion Criteria:

• History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
• Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
• COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.