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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berodual® Respimat®, low dose | Experimental |
| |
| Berodual® Respimat®, high dose | Experimental |
| |
| Berodual® MDI Aerochamber® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berodual® Respimat®, low dose | Drug |
| ||
| Berodual® Respimat®, high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average FEV1 AUC0-1 (FEV1( (Forced expiratory volume in one second) AUC0-1(Area under the curve between 0 and 1 hour )) | pre-dose and 5, 30, 60 minutes post-dose on day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Average FEV1 between 0 and 1 hour (FEV1 AUC0-1) | 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) | pre-dose and 5, 30, 60 minutes post-dose on day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
|
| Berodual® MDI | Drug |
|
| FVC (Forced vital capacity) | 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 | pre-dose and 5, 30, 60 minutes post-dose on days 1, 15 and 29 |
| FEV1max | pre-dose and 5, 30, 60 minutes post-dose on days 1 and 29 |
| Onset of therapeutic response | Days 1 and 29 |
| Peak expiratory flow (PEF) | pre-dose until day 29 |
| Extent of use of rescue bronchodilator medication | up to day 29 |
| Overall incidence of adverse events | up to day 29 |
| Occurrence of application induced bronchoconstriction | up to day 29 |
| Number of patients with clinically significant changes in heart rate | pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29 |
| Number of patients with clinically significant changes in blood pressure | pre-dose and 5, 30, 60 minutes post-dose on days 1, 15, 29 |
| Number of patients with abnormal findings in physical examination | Baseline, day 29 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |