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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
892
Average forced expiratory volume in one second (FEV1) between 0 and 1 hour (Area under the curve (AUC0-1h)) in litres
Time frame: after 12 weeks of treatment
Average (FEV1) between 0 and 1 hour (AUC0-1h) in litres on previous test days
Time frame: on day 1, 29, 57
Forced vital capacity (FVC) in litres measured at the same time as FEV1
Time frame: on day 1, 29, 57 and 85
Peak FEV1 between 0 and 1 hour post inhalation of study drug
Time frame: on day 1 and 85
Onset of bronchodilatory response
Linear interpolation of the time of the first therapeutic response and the observation just prior to to the first therapeutic response. Therapeutic response was defined as FEV1 measurement exceeding 1.15 times of the pre-dose value that was recorded at any time point during the one hour observation period.
Time frame: on day 1 and 85
Peak expiratory flow (PEF) measured pre-medication, morning and evening, averaged weekly
Time frame: up to 12 weeks
Symptom scores recorded on the patient diary card
Time frame: up to 12 weeks
Use of rescue bronchodilator medication
Time frame: up to 12 weeks
Number of patients with adverse events
Time frame: up to 12 weeks
Total average FEV1 (TAUC0-1h)
Time frame: day 85
Number of patients with clinically significant changes in vital signs
Time frame: up to 12 weeks
Number of patients with clinically significant changes in laboratory parameters
Time frame: Baseline and day 85
Number of patients with abnormal findings in physical examination
Time frame: Baseline and day 85
Number of patients with clinically significant changes in electrocardiogram
Time frame: Baseline and day 85
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