Clinical Trial Results:
A phase II, randomised, partially-blinded, cross over study to evaluate the systemic effect of two doses of the SMB BUDESONIDE-SALMETEROL DPI fixed-dose combination capsule (300/25 µg BID and 150/25 µg BID) delivered by the AXAHALER® versus PULMICORT® TURBOHALER® 400µg BID and SEREVENT® DISKUS® 50µg BID versus placebo in mild persistent asthmatic patients.
Summary
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EudraCT number |
2010-020794-16 |
Trial protocol |
BG |
Global completion date |
25 Mar 2011
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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.