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The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| change in FEV1 from baseline during the treatment period; number of COPD exacerbations. |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary function variables | ||
| number of COPD exacerbations of different type and various subgroups | ||
| quality of life variables |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALTANA Pharma | Cities in Alabama | Alabama | United States | |||
| ALTANA Pharma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28419462 | Derived | Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17. | |
| 21272339 | Derived | Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18. |
| Label | URL |
|---|---|
| BY217-M2-111-RDS-2008-12-23.pdf | View source |
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| patient diary variables |
| time to study withdrawal |
| safety. |
| Cities in Arizona |
| Arizona |
| United States |
| ALTANA Pharma | Cities in Arkansas | Arkansas | United States |
| ALTANA Pharma | Cities in California | California | United States |
| ALTANA Pharma | Cities in Colorado | Colorado | United States |
| ALTANA Pharma | Cities in Connecticut | Connecticut | United States |
| ALTANA Pharma | Cities in Florida | Florida | United States |
| ALTANA Pharma | Cities in Georgia | Georgia | United States |
| ALTANA Pharma | Cities in Illionois | Illinois | United States |
| ALTANA Pharma | Cities in Iowa | Iowa | United States |
| ALTANA Pharma | Cities in Kentucky | Kentucky | United States |
| ALTANA Pharma | Cities in Louisiana | Louisiana | United States |
| ALTANA Pharma | Cities in Massachusetts | Massachusetts | United States |
| ALTANA Pharma | Cities in Minnesota | Minnesota | United States |
| ALTANA Pharma | Cities in Missouri | Missouri | United States |
| ALTANA Pharma | Cities in Montana | Montana | United States |
| ALTANA Pharma | Cities in Nebraska | Nebraska | United States |
| ALTANA Pharma | Cities in Nevada | Nevada | United States |
| ALTANA Pharma | Cities in New Hampshire | New Hampshire | United States |
| ALTANA Pharma | Cities in New Jersey | New Jersey | United States |
| ALTANA Pharma | Cities in New York | New York | United States |
| ALTANA Pharma | Cities in North Carolina | North Carolina | United States |
| ALTANA Pharma | Cities in Ohio | Ohio | United States |
| ALTANA Pharma | Cities in Oklahoma | Oklahoma | United States |
| ALTANA Pharma | Cities in Oregon | Oregon | United States |
| ALTANA Pharma | Cities in Pennsylvania | Pennsylvania | United States |
| ALTANA Pharma | Cities in Rhode Island | Rhode Island | United States |
| ALTANA Pharma | Cities in South Carolina | South Carolina | United States |
| ALTANA Pharma | Cities in Tennessee | Tennessee | United States |
| ALTANA Pharma | Cities in Texas | Texas | United States |
| ALTANA Pharma | Cities in Utah | Utah | United States |
| ALTANA Pharma | Cities in Vermont | Vermont | United States |
| ALTANA Pharma | Cities in Virginia | Virginia | United States |
| ALTANA Pharma | Cities in West Virginia | West Virginia | United States |
| ALTANA Pharma | Cities in Wisconsin | Wisconsin | United States |
| ALTANA Pharma | Cities in Canada | Canada |
| ALTANA Pharma | Cities in France | France |
| ALTANA Pharma | Cities in Germany | Germany |
| ALTANA Pharma | Cities in Poland | Poland |
| ALTANA Pharma | Cities in South Africa | South Africa |
| 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 |
|---|---|
| C424423 | Roflumilast |
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