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 t.i.d.) administered via Respimat® device 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 t.i.d.) administered via the MDI (chlorofluorocarbon-metered dose inhaler) with Aerochamber® and that the safety profile is at least as good when paediatric asthma patients are treated for four weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
535
Change in average FEV1 AUC0-1 (FEV1( (Forced expiratory volume in one second) AUC0-1(Area under the curve between 0 and 1 hour ))
Time frame: pre-dose and 5, 30, 60 minutes post-dose on day 29
Average FEV1 between 0 and 1 hour (FEV1 AUC0-1)
Time frame: pre-dose and 5, 30, 60 minutes post-dose on days 1 and 15
Total average FEV1 between 0 and 1 hour (FEV1 AUC0-1)
Time frame: pre-dose and 5, 30, 60 minutes post-dose on day 29
FVC (Forced vital capacity)
Time frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29
FEV25-75% (mean forced expiratory flow during the middle half of the FVC
Time frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29
FEV1max
Time frame: pre-dose and 5, 30, 60 minutes post-dose on days 1 and 29
Onset of therapeutic response
Time frame: Days 1 and 29
Peak expiratory flow (PEF)
Time frame: pre-dose until day 29
Extent of use of rescue bronchodilator medication
Time frame: up to day 29
Overall incidence of adverse events
Time frame: up to day 29
Occurrence of application induced bronchoconstriction
Time frame: up to day 29
Number of patients with clinically significant changes in heart rate
Time frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29
Number of patients with clinically significant changes in blood pressure
Time frame: pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29
Number of patients with abnormal findings in physical examination
Time frame: Baseline, day 29
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