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The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life 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 |
|---|---|---|
| The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period. | ||
| Change in FEV1 from baseline during the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function variables; quality of life variables;patient diary variables;safety |
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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 Australia | Australia | ||||
| 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-M2-112-RDS-2005-05-11.pdf | View source |
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| Cities in Austria |
| Austria |
| ALTANA Pharma | Cities in Canada | Canada |
| ALTANA Pharma | Cities in France | France |
| ALTANA Pharma | Cities in Hungary | Hungary |
| ALTANA Pharma | Cities in Italy | Italy |
| ALTANA Pharma | Cities in the Netherlands | Netherlands |
| ALTANA Pharma | Cities in Poland | Poland |
| ALTANA Pharma | Cities in Portugal | Portugal |
| ALTANA Pharma | Cities in the Russian Federation | Russia |
| ALTANA Pharma | Cities in South Africa | South Africa |
| ALTANA Pharma | Cities in Spain | Spain |
| ALTANA Pharma | Cities in Switzerland | Switzerland |
| ALTANA Pharma | Cities in the United Kingdom | United Kingdom |
| 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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