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The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ba253BINEB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ba253BINEB | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | 30 weeks | |
| Number of patients with abnormal changes in blood pressure and heart rate | Baseline, up to 28 weeks | |
| Number of patients with abnormal changes in ECG (electrocardiogram) | Baseline, up to 28 weeks | |
| Number of patients with abnormal changes in laboratory parameters | Baseline, up to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in symptom score | Baseline, up to 28 weeks | |
| Change from baseline in treatment score | Baseline, up to 28 weeks | |
| Change from baseline in asthma score |
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Inclusion Criteria:
The patients with bronchial asthma and who satisfy the following 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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| Baseline, week 28 |
| Change from baseline in daily life score | Baseline, up to 28 weeks |
| Change from baseline in nocturnal sleep score | Baseline, up to 28 weeks |
| Change from baseline in Peak expiratory flow rate (PEFR) | Baseline, up to 28 weeks |
| Physician's global evaluation (overall improvement and final overall improvement) | Baseline, up to 28 weeks |
| Patient's impression | Week 28 |
| Change from baseline in FEV1 (Forced expiratory volume in one second) | Baseline, up to 28 weeks |
| Change from baseline in FVC (Forced vital capacity) | Baseline, up to 28 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |