Clinical Trial Results:
A 12-month open-label, randomized parallel-group study to investigate the influence of salmeterol/fluticasone either in fixed combination (SFC500/50 µg bid) or seperately (SAL 50 µg and FP 500 µg bid) via Diskus inhaler(s) on course of the disease and frequency of exacerbations in subjects with severe and very severe COPD (GOLD Stage III and IV)
Summary
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EudraCT number |
2007-003597-25 |
Trial protocol |
DE |
Global completion date |
25 Jun 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 |
08 Mar 2018
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First version publication date |
08 Mar 2018
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Other versions |
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Summary report(s) |
107227-FDAAA-Result-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.