Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

An Open Phase III, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18 μg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).

Inclusion Criteria:

• Outpatients, men or women ≥ 40 years
• A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
• Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%, post-bronchodilator

Exclusion Criteria:

• A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis
• Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start.
• Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator