Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU

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)

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Inclusion Criteria:

• Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
• Current or previous smoker with a smoking history of 10 or more pack years
• Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value

Exclusion Criteria:

• History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
• Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
• Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.