Clinical Trial Results:
A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®.
Summary
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EudraCT number |
2009-015713-51 |
Trial protocol |
DE BE FI LV HU NO LT SK SE ES NL DK PT GR AT IT IE BG GB |
Global completion date |
23 May 2013
|
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 |
16 May 2016
|
First version publication date |
06 May 2015
|
Other versions |
|
Summary report(s) |
205.452 |
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.