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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023751 |
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The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with either Oxis Turbuhaler or Symbicort Turbuhaler.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Single Dose evaluation placebo (V5) |
|
| 2 | Active Comparator | Single Dose evaluation formoterol (V5) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol Turbuhaler | Drug | 9 microgram on visit 5 single dose |
| |
| Budesonide/Formoterol Turbuhaler |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen enhanced MRI V4 | Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters | Visit 4 |
| Oxygen enhanced MRI V5 | Oxygen enhanced MRI parameters | Visit 5 |
| Oxygen enhanced MRI V7 | Oxygen enhanced MRI parameters | Visit 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Transferability of OE-MRI technique | Transferability of OE-MRI technique to a second centre | 10 months |
| OE-MRI variables | Relationship with OE-MRI variables and change in lung function |
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Inclusion Criteria:
Clinical Study Protocol Local Amendment affects UK:
- FEV1 > 30 % PN and < 80 % PN (post-bronchodilator)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Lund | Sweden | ||||
| Research Site |
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| Drug |
320/9 microgram twice daily during 8 weeks |
|
| Formoterol Turbuhaler | Drug | 9 microgram twice daily during 8 weeks |
|
| patients will fill in a patient diary at home between visit 2 and 7 |
| Impulse oscillometry parameters V2 | Impulse oscillometry parameters | Visit 2 |
| Impulse oscillometry parameters V4 | Impulse oscillometry parameters | Visit 4 |
| Impulse oscillometry parameters V5 | Impulse oscillometry parameters | Visit 5 |
| Impulse oscillometry parameters V7 | Impulse oscillometry parameters | Visit 7 |
| Manchester |
| United Kingdom |
| 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 |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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