Clinical Trial Results:
A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 μg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma
Summary
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EudraCT number |
2008-001413-14 |
Trial protocol |
DE NL IT GB |
Global completion date |
25 Jul 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 |
v2(current) |
This version publication date |
16 May 2016
|
First version publication date |
26 Feb 2015
|
Other versions |
v1 |
Version creation reason |
|
Summary report(s) |
205.416 205.416_205.417 |
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.