Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II

Inclusion criteria

• Signed informed consent prior to participation.
• Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.
• Male or female between 40 and 75 years of age.
• Current or ex-smokers with smoking history of more than 10-pack years.
• Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.
• Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.

Exclusion criteria

• 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.
• Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
• Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).
• 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 or contraindications to exercise.
• Patients who have undergone thoracotomy with pulmonary resection.
• 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.
• Patients who regularly use daytime oxygen for more than one hour per day.
• Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
• Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
• Pregnant or nursing women.
• Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).