Clinical Trial Results:
A 12-WEEK, MULTINATIONAL, MULTICENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF CHF 1535 200/6µg (FIXED COMBINATION BECLOMETHASONE DIPROPIONATE / FORMOTEROL) VERSUS BECLOMETHASONE DIPROPIONATE IN ADULTS ASTHMATIC PATIENTS NOT ADEQUATELY CONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS OR ON MEDIUM DOSE OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING β2 AGONISTS
Summary
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EudraCT number |
2010-020602-14 |
Trial protocol |
DE GB HU CZ IT PL BG |
Global completion date |
29 Nov 2012
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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 |
18 Nov 2016
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First version publication date |
18 Nov 2016
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Other versions |
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Summary report(s) |
ICH E3 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.