Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD

Inclusion Criteria

• All patients must sign an informed consent consistent with GCP guidelines prior to participation in the trial.
• All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe airway obstruction with a post-bronchodilator FEV1 >=30% of predicted normal and 80 IU/L, ALT >80 IU/L, bilirubin >1.5 x ULN or creatinine >1.5 x ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients)
• Patients with a history of asthma or a total blood eosinophil count >=600/mm3. A repeat eosinophil count will not be conducted in these patients
• Patients with any of the following conditions:
• a diagnosis of thyrotoxicosis
• a diagnosis of paroxysmal tachycardia (>100 beats per minute)
• a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms) as recommended by ICH E14. For patients who have a QTc interval between 450 ms and 500 ms, as judged by site personnel, there will be a confirmatory reading by centralized evaluation institute. If the confirmatory reading is still greater than 450 ms, patient will be excluded. Patients with a QTc interval >=500 ms will immediately be excluded from the study.
• a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) as recommended by ICH E14.
• Patients with any of the following conditions:
• a history of myocardial infarction within 1 year
• a diagnosis of clinically relevant cardiac arrhythmia
• known active tuberculosis
• a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last 5 years (patients with treated basal cell carcinoma are allowed)
• a history of life-threatening pulmonary obstruction
• a history of cystic fibrosis
• clinically evident bronchiectasis
• a history of significant alcohol or drug abuse
• Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
• Patients being treated with any of the following concomitant medications:
• medications that prolong the QT/QTc interval
• oral beta-adrenergics and beta-adrenergics patchs
• beta-blockers (topical beta-blockers for ocular conditions are allowed)
• oral corticosteroid medication at unstable doses (i.e. less than 6 weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
• Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
• Patients who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
• Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening visit
• Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other component of the Respimat inhalation solution delivery system
• Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women
• Patients who have previously been participated in this study or are currently participating in another study
• Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
• The randomization of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the screening visit or during the screening period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation