Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler Compared to Ipratropium Bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo in Adults With Chronic Obstructive Pulmonary Disease

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study

Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded

All patients with a SGOT (serum glutamic oxaloacetic transaminase) \>80 IU/L, SGPT (serum glutamic pyruvic transaminase) \>80 IU/L, bilirubin \>2.0 mg/dL or creatinine \>2.0 mg/dL will be excluded regardless of the clinical condition

Patients who have a total blood eosinophil count ≥600/mm3

Patients with a recent history (i.e., one year or less) of myocardial infarction

Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy

Patients with a history of cancer, other than treated basal cell carcinoma, within the last 5 years

Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis

Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1

Patients with a history of asthma or allergic rhinitis

Patients with a history of and/or active alcohol or drug abuse

Patients with known active tuberculosis

Patients with an upper or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period

Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction

Patients with known narrow-angle glaucoma

Patients with current significant psychiatric disorders

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

Patients who are being treated with cromolyn sodium or nedocromil sodium

Patients who are being treated with antihistamines for any excluded allergic conditions

Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day

Patients who initiated use of an inhaled steroid or changed doses less than 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period

Patients who are being treated with beta-blocker medications, MAO (monoamine oxidase) inhibitors or tricyclic antidepressants. Beta blocker eye medications (e.g., Betoptic) for treatment of non-narrow angle glaucoma are allowed

Patients who have had changes in their therapeutic plan within the last 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period

Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception

Patients with known hypersensitivity to anticholinergic drugs or any component of the ipratropium bromide/salbutamol Respimat® solution (including BAC (Benzalkonium chloride) and EDTA (Ethylenediaminetetraacetic acid)) or the ipratropium bromide/salbutamol MDI components

Previous participation in this study

Patients who are currently participating in another study

What this study is about