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)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: 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