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
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
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