Clinical Trial Results:
A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 μg [2 actuations of 2.5 μg] and 10 μg [2 actuations of 5 μg]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 μg) Delivered by the Aerolizer® Inhaler, in Patients with Chronic Obstructive Pulmonary Disease (COPD).
Summary
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EudraCT number |
2008-001934-28 |
Trial protocol |
FI SE CZ DK DE IT |
Global completion date |
08 Dec 2010
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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 |
16 May 2016
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First version publication date |
05 Apr 2015
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Other versions |
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Summary report(s) |
1222.14 |
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.