Clinical Trial Results:
A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 μg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 220 μg b.i.d. in patients with asthma inadequately controlled on low dose ICS therapy.
Summary
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EudraCT number |
2010-023168-41 |
Trial protocol |
DE BG FR SK |
Global completion date |
23 Dec 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 |
10 Mar 2016
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First version publication date |
10 Mar 2016
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Other versions |
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Summary report(s) |
Trial Synopsis |
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.