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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra CT 2005-001090-10 | |||
| SPACE |
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To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide/formoterol | Drug |
| ||
| Prednisolone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in one second (FEV1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment failures | ||
| Time to first exacerbation | ||
| Number of patients developing an exacerbation |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion and exclusion criteria will be evaluated by the investigator
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19228428 | Derived | Stallberg B, Selroos O, Vogelmeier C, Andersson E, Ekstrom T, Larsson K. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. Respir Res. 2009 Feb 19;10(1):11. doi: 10.1186/1465-9921-10-11. |
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| Diary cards |
| Quality of Life |
| - Adverse Events (AEs) |
| Serious Adverse Events (SAEs) and Discontinuations due to AEs |
| Variables will be assessed before and over the 2+12 weeks treatment period |
| Ålbæk |
| Denmark |
| Research Site | Christiansfeld | Denmark |
| Research Site | Erfurt | Denmark |
| Research Site | Nørager | Denmark |
| Research Site | Oksbøl | Denmark |
| Research Site | Sæby | Denmark |
| Research Site | Ekenäs | Finland |
| Research Site | Jakobstad | Finland |
| Research Site | Lohja | Finland |
| Research Site | Porvoo | Finland |
| Research Site | Berlin | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Marburg | Germany |
| Research Site | Fredrikstad | Norway |
| Research Site | Harstad | Norway |
| Research Site | Molde | Norway |
| Research Site | Oslo | Norway |
| Research Site | Straume | Norway |
| Research Site | Alingsås | Sweden |
| Research Site | Åkersberga | Sweden |
| Research Site | Åtvidaberg | Sweden |
| Research Site | Borlänge | Sweden |
| Research Site | Gothenburg | Sweden |
| Research Site | Höllviken | Sweden |
| Research Site | Kilafors | Sweden |
| Research Site | Limhamn | Sweden |
| Research Site | Lindesberg | Sweden |
| Research Site | Luleå | Sweden |
| Research Site | Malmö | Sweden |
| Research Site | Motala | Sweden |
| Research Site | Örebro | Sweden |
| Research Site | Sigtuna | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Trosa | Sweden |
| Research Site | Tumba | Sweden |
| Research Site | Uppsala | Sweden |
| 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 |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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