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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose multislice CT thorax | Radiation | All patients will have 2 low dose multi-slice CT's at visit 2: one CT "pre-dose" and one CT 1 to 3 hours "post-dose". | ||
| AlphaCore® device | Device | All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in functional imaging parameters | The primary objective of this study is to evaluate the effect of the AlphaCore® on central and peripheral airway dimensions with functional imaging using airway segmentation and computational methods (CFD). | At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lung function parameters | The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L. | At V2 (2 - 14 days after screening) pre and post treatment with the AlphaCore device |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital 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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| Changes in patient reports outcomes (PROs) | The secondary objectives of this study are to assess the effects after treatment with the AlphaCore® on lung function (spirometry, resistance and diffusion), on COPD Assessment Test (CAT), on Modified Medical Research Council (MMRC), on Saint George's Respiratory Questionnaire (SGRQ) and on health questionnaire EQ-5D-5L. | At V2 before treatment with the AlphaCore device and at follow-up visit (14 days after visit 2) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |