Clinical Trial Results:
A randomised, double blind, double dummy, multicentre phase III study comparing the efficacy of budesonide/formoterol (Symbicort® forte Turbuhaler®) and oral prednisolone + formoterol (Oxis® Turbuhaler) during two weeks, in COPD patients with an acute exacerbation, followed by twelve weeks open follow up period with budesonide/formoterol (Symbicort forte Turbuhaler) - SPACE
Summary
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EudraCT number |
2005-001090-10 |
Trial protocol |
SE FI DK DE |
Global completion date |
11 Jul 2007
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jun 2016
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First version publication date |
05 Jun 2016
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Other versions |
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Summary report(s) |
D5892L00002_synopsis.pdf |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.