Study 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 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 MDI and that the safety profile is at least as good in asthma patients treated for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
631
Change in average FEV1 (Forced expiratory volume in one second) (AUC0-6 (Area under the curve))
Time frame: Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
FEV1max
Time frame: Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
Time to onset of therapeutic response
Time frame: Days 1, 29, 57 and 85
Duration of therapeutic response
Time frame: Days 1, 29, 57 and 85
Time to peak FEV1
Time frame: Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
Change in averaged weekly morning and evening pre-dose PEFR (peak expiratory flow rate)
Time frame: up to day 85
Extent of use of rescue medication
Time frame: up to day 85
Change in night-time and daytime symptom scores
Time frame: up to day 85
Overall incidence of adverse events
Time frame: up to day 85
Number of patients with clinically significant changes in Heart rate
Time frame: Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
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Number of patients with clinically significant changes in Blood pressure
Time frame: Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
Number of patients with clinically significant changes from baseline in laboratory investigations
Time frame: Baseline and day 85
Incidence of paradoxical bronchoconstriction
Time frame: up to day 85