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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 | Up to 28 weeks | |
| Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate) | Baseline, up to week 28 | |
| Number of patients with abnormal changes from baseline in electrocardiogram (ECG) | Baseline, up to week 28 | |
| Number of patients wiht abnormal changes from baseline in laboratory tests | Baseline, up to week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in FEV1 (Forced expiratory volume in one second) | Baseline, up to week 28 | |
| Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep) | Baseline, up to week 28 |
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Inclusion Criteria:
The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
Exclusion Criteria:
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Physician's global evaluation (overall improvement) | Up to week 28 |
| Patient's impression | Week 28 |
| Physician's global evaluation (final improvement) | Week 28 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |