Clinical Trial Results:
A phase III, randomized, parallel group, open study to compare the therapeutic efficacy and safety of SMB BUDESONIDE-SALMETEROL DPI capsule 150/25μg BID delivered by the AXAHALER® versus SYMBICORT® TURBUHALER® 200/12μg BID over 12 weeks in moderate to severe persistent asthmatic patients.
Summary
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EudraCT number |
2008-004833-70 |
Trial protocol |
BG |
Global completion date |
06 Aug 2009
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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 |
01 Feb 2016
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First version publication date |
23 Aug 2014
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Other versions |
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Summary report(s) |
Clinical Report Summary |
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.