Clinical Trial Results:
EVALUATION OF THE 24-HOUR TROUGH FEV1 FOLLOWING 7 DAYS OF DOSING WITH CHF4226 2µg ONCE DAILY.
A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL GROUP, PLACEBO AND ACTIVE (FORMOTEROL 12µg B.I.D.) CONTROLLED STUDY FOLLOWED BY A 3-WEEK OPEN LABEL EXTENSION (TO EITHER CHF4226 2µg Q.D. OR FORMOTEROL 12µg B.I.D. IN A 2:1 RATIO) FOR THE EVALUATION OF SAFETY AND TOLERABILITY
Summary
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EudraCT number |
2005-002195-15 |
Trial protocol |
GB |
Global completion date |
05 Nov 2005
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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 |
01 Jan 2017
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First version publication date |
01 Jan 2017
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Other versions |
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Summary report(s) |
EudraCT No. 2005-002195-15 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.