Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

Exclusion Criteria

• •1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN
• •2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
• •3. Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute)
• •4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
• •5. Patients who have undergone thoracotomy with pulmonary resection
• •6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six 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.
• •7. Patients who regularly use daytime oxygen therapy for more than one hour per day.
• •8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
• •9. Pregnant or nursing women
• •10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).