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No new investigational product can be delivered to the site.
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In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.
In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4.
The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.
Image 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 | Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment |
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| Placebo | Placebo Comparator | Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRCT scan | Radiation | HRCT scan of thorax, at baseline and after 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Airway volume (iVaw) | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | At baseline and after 3 months of treatment |
| Changes in Airway resistance (iRaw) | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | At baseline and after 3 months of treatment |
| Changes in Lobe volumes (iVlobes) | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | At baseline and after 3 months of treatment |
| Changes in Air trapping | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | At baseline and after 3 months of treatment |
| Changes in Internal Lobar Airflow Distribution | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | At baseline and after 3 months of treatment |
| Low Attenuation or Emphysema Score | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Spirometry | Spirometry is a composite outcome measure consisting of the following parameters:
| At baseline and after 3 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Backer, M.D., M.S. | University Hospital of Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Antwerp | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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| Placebo of Roflumilast | Drug | Placebo, once a day in the morning during 3 months |
|
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| Roflumilast | Drug | Roflumilast, once a day in the morning during 3 months |
|
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| At baseline and after 3 months of treatment |
| Changes in Blood Vessel Density | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | At baseline and after 3 months of treatment |
| Changes in Airway Wall Thickness | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | 3 months |
| Aerosol deposition concentrations | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. | At baseline and after 3 months of treatment |
| Changes in Body plethysmography |
Body plethysmography is a composite outcome measure consisting of the following parameters:
|
| At baseline and after 3 months of treatment |
| Changes in Diffusion capacity | Diffusion capacity is a composite outcome measure consisting of the following parameters:
| At baseline and after 3 months of treatment |
| Changes in 6MWT | Exercise capacity: distance walked in 6 minutes (m), oxygen saturation measurement will be performed during the test | At baseline and after 3 months of treatment |
| Changes in Patient Related Outcome (PRO) | Patient Related Outcome is a composite outcome measure consisting of the following questionnaires:
| At baseline and after 3 months of treatment |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |