Clinical Trial Results:
A phase III, randomized, parallel group study to compare the therapeutic efficacy
of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25μg BID delivered by
the AXAHALER® versus SERETIDE® DISKUS® 500/50μg (Fluticasone
propionate 500μg/Salmeterol 50μg) BID over 12 weeks and to evaluate the safety of
SMB BUDESONIDE-SALMETEROL 300/25μg over an additional period of 12
weeks in moderate to severe persistent asthmatic patients.
Summary
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EudraCT number |
2006-001514-33 |
Trial protocol |
FI EE |
Global completion date |
14 Mar 2008
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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
|
First version publication date |
22 Aug 2014
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Other versions |
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Summary report(s) |
Clinical Study 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.