Comparison of Safety and Efficacy of Berodual® Administered Via the Respimat® Device With That Administered Via the Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion criteria

• Age >= 40 years
• Diagnosis of COPD according the following criteria:

• screening FEV1<= 65% predicted
• Screening FEV1/FVC <= 70%
• Smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent
• Able to be trained in the proper use of MDI and Respimat®
• Able to be trained in the performance of technically satisfactory pulmonary function tests
• All patients must be willing and able to sign informed consent in accordance with Good clinical Practice (GCP) and local legislation

Exclusion criteria

• History of cardiovascular, renal, neurologic, liver or endocrine dysfunction (e.g. hyperthyreosis) if they are clinically significant. A clinically significant disease is defined as one 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 or the study or the patient's ability to participate in the study
• Patients with a recent (<= one year) history of myocardial infarction
• Tuberculosis with indication for treatment
• History of cancer within the last five years (excluding basal carcinoma)
• Patients who have undergone thoracotomy
• Current psychiatric disorders
• History of life-threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
• An upper and lower respiratory tract infection in the four weeks prior to the screening visit
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
• Patients with known narrow-angle glaucoma or raised intra-ocular pressure
• Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion
• Patients with:

• Serum glutamic oxalo-acetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) >200% of the upper limit of the normal range
• Bilirubin >150% of the upper limit of the normal range
• Creatinine >125% of the upper limit of the normal range
• Patients who are on chronic oxygen therapy
• Intolerance to aerosolised ipratropium- or fenoterol-containing products, or hypersensitivity to any of the MDI ingredients
• Oral corticosteroid mediation at dose greater than 10 mg prednisolone per day or equivalent
• Beta-blocker medication
• Changes in the pulmonary therapeutic plan within the last four weeks prior to the screening visit (not including withholding of medication before the screening visit)
• Concomitant or recent (within the last month) use of investigational drugs
• History of drug abuse and/or alcoholism
• Pregnant or nursing women and women of child-bearing potential not using a medically approved means of contraception
• Previous participation in this study (i.e. having been allocated a randomized treatment number)
• Patients with a history of asthma, allergic rhinitis or atopy or who have blood eosinophil count above 600/mm3 (a repeat eosinophil count will not be conducted in these patients) and those patients on antihistamines, anti-leukotrienes, sodium cromoglycate or nedocromil sodium
• Patients who are unable to comply with the medication restrictions specified in section 4.2 or who cannot use an MDI without a spacer