Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Exclusion Criteria

• •1. Patients with a significant disease other than COPD
• •2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
• •3. Patients with a history of asthma or a total blood eosinophil count \>= 600/mm3.
• •4. 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 QTcF\* interval \> 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
• •5. Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
• •6. Patients who have undergone thoracotomy with pulmonary resection
• •7. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
• •8. Pregnant or nursing women
• •9. Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
• •10. Patients who have previously been randomized in this study or are currently participating in another study
• •11. Patients who are unable to comply with pulmonary medication restrictions prior to randomization
• •12. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit