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The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aclidinium bromide | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aclidinium bromide 400 μg | Drug |
| ||
| aclidinium bromide placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 12 in morning predose (trough) FEV1 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 12 in peak FEV1 | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26370136 | Derived | Lee SH, Lee J, Yoo KH, Uh ST, Park MJ, Lee SY, Kim JY, Kim DK, Kim SJ, Lee KH, Yoo CG. Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population. Respirology. 2015 Nov;20(8):1222-8. doi: 10.1111/resp.12641. Epub 2015 Sep 15. |
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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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| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
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