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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT no. 2004-004042-41 |
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The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Formoterol Turbuhaler | Drug |
| ||
| Budesonide Turbuhaler (Pulmicort) | Drug | |||
| Terbutaline Turbuhaler | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunopathology and remodeling in biopsies | ||
| Immunopathology and mediators in induced sputum | ||
| Severe asthma exacerbations (number of and time to first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aalborg | Denmark | ||||
| Research Site |
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| Forced expiratory volume in 1 second (FEV1) |
| As-needed use |
| Safety variables, including adverse events and vital signs |
| All variables assessed over the 12-month treatment period |
| Århus C |
| Denmark |
| Research Site | Copenhagen | Denmark |
| Research Site | Montpellier | France |
| Research Site | Pessac | France |
| Research Site | Hanover | Germany |
| Research Site | Mainz | Germany |
| Research Site | Marburg | Germany |
| Research Site | Baraclado | Spain |
| Research Site | Barcelona No. 40 | Spain |
| Research Site | Barcelona, No. 42 | Spain |
| Research Site | Gothenburg | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Umeå | Sweden |
| Research Site | Uppsala | Sweden |
| Research Site | Glasgow | United Kingdom |
| Research Site | Leicester | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Newcastle upon Tyne | United Kingdom |
| Research Site | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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