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)

To demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium bromide, 1 puff q.i.d) administered via the Respimat® gives a bronchodilator response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg ipratropium bromide, 2 puffs q.i.d) administered via the MDI and that the safety profile is at least as good when COPD patients are treated for 12 weeks.


Eligibility Criteria:
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