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Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combivent® HFA | Experimental |
| |
| Combivent® CFC | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combivent® HFA inhalation aerosol | Drug |
| ||
| Combivent® CFC inhalation aerosol |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals) | Baseline, up to 8 days after last treatment day | |
| Number of patients with clinically significant changes in vital signs (blood pressure, puls rate, respiratory rate) | Baseline, up to 8 days after last treatment day | |
| Changes in intra ocular pressure (IOP) | Baseline, up to 30 min after last drug administration | |
| Changes in serum potassium levels | Baseline, up to 180 min after last drug administration | |
| Changes in serum glucose levels | Baseline, up to 60 min after last drug administration | |
| Number of patients with clinically significant changes from baseline in clinical laboratory evaluations | Baseline, 8 days after last treatment day | |
| Number of patients with adverse events including paradoxical bronchospasm | Up to 8 days after last treatment day | |
| Number of patients with clinically significant changes from baseline in physical examination | Baseline, 8 days after last treatment day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 (forced expiratory volume in one second) | Baseline, up to 180 min after last drug administration | |
| Change in FVC (forced vital capacity) | Baseline, up to 180 min after last drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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