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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016502-16 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort® forte Turbohaler® | Other |
| |
| Placebo (lactose) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort® forte Turbohaler® | Drug | 320 µg budesonide / 9 µg formoterol fumarate dihydrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| total airway resistance | To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume. | |
| total airway volume | To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume. |
| Measure | Description | Time Frame |
|---|---|---|
| effect of formoterol and budesonide combination therapy on lung function | The secondary objective of this study is to assess the effect of formoterol and budesonide combination therapy on lung function (spirometry, body plethysmography and resistance). |
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Inclusion Criteria:
Patients with documented COPD based on the following criteria:
Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC < 0.70).
Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
Male or female patients aged ≥ 40 years.
Patients should be treated according to GOLD guidelines before study start.
Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
Maintained on stable respiratory medications for 6 weeks prior to visit 1.
Written informed consent obtained.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried A De Backer, MD PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Edegem (Antwerp) | 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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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |