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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004271-36 | EudraCT Number |
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In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV.
Imaging parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | Roflumilast 500 µg, once a day in the morning during 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in airway geometry and function using CT based functional respiratory imaging. | The primary objective of this study is to evaluate the possible use of CT based functional respiratory imaging (CT-FRI) on the phenotyping of severe COPD patients after a 6 month treatment with Daxas®. | At baseline and after 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique) | Imaging parameters will be assessed and the correlation with lung function will be checked before and after treatment. | At baseline and after 6 months of treatment |
| Health related quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Backer, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Lieven Bedert, MD | ZNA Middelheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Antwerp | Antwerp | 2020 | Belgium | ||
| Antwerp University Hospital |
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| Placebo of Roflumilast | Drug | Placebo 500 µg, once a day in the morning during 6 months |
|
| Functional Respiratory Imaging | Radiation | CT scan of thorax, at baseline and after 6 months |
|
Imaging parameters will be assessed and the correlation with health related quality of life will be checked before and after treatment. |
| At baseline and after 6 months of treatment |
| Edegem |
| Antwerp |
| 2650 |
| Belgium |
| 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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