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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019864-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
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The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inuvair | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inuvair | Drug | 6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral airway resistance (from 4th bifurcation on) for the segmented airways | at baseline and after 6 months of treatment | |
| Total airway volume for the segmented airways | at baseline and after 6 months of treatment | |
| Peripheral airway volume (from the 4th bifurcation on) for the segmented airways | at baseline and after 6 months of treatment | |
| Relative compliance for each lobe | at baseline and after 6 months of treatment | |
| Density of the lung parenchyma given per predefined lung zone | at baseline and after 6 months of treatment | |
| Total airway resistance for the segmented airways | at baseline and after 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| BODE index | The BODE index is a multidimensional index of disease severity . The index uses following parameters:
| at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8) |
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Inclusion Criteria:
Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC < 0.70
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried A De Backer, MD PhD | University Hospital of Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Antwerp | Edegem (Antwerp) | Antwerp | B-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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| COPD assessment test | The COPD assessment measures the impact of COPD on a person's life. | at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8) |
| Borg CR10 Scale | The Borg CR10 Scale measures the present dyspnea. | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Adverse events as a measure of safety | During the study patients will record record each day taken medication and any possible comments on the daily diary cards. Further more, patients are contacted at least once a month (either by phone or at a visit in the hospital). | during the study patients will record record each day taken medication and any possible comments on the daily diary cards |
| Forced expiratory volume in 1 second (FEV1) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Forced Vital Capacity (FVC) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Peak Expiratory Flow (PEF) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Maximum expiratory flow rate at 50% of vital capacity (MEF50) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Maximal expiratory flow rate at 25% of vital capacity (MEF25) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Vital capacity (VC) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Inspiratory vital capacity (IVC) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Functional residual capacity (FRC) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Total Lung Capacity (TLC) | At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Airway resistance (Raw) | At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| Specific airways conductance (SGaw) | At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |