Clinical Trial Results:
A phase III, 8-week, multinational, multicentre, randomized, double-blind, triple-dummy, active controlled, 3-arm parallel-group clinical trial to test the efficacy of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) via NEXT DPI® 1 inhalation bid versus same dose of CHF 1535 pMDI and marketed beclomethasone DPI 100 µg 1 inhalation bid on Peak Expiratory Flow in adult asthmatic patients after one month of treatment with marketed fixed dose combination of FOSTER® 1 inhalation bid.
Summary
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EudraCT number |
2010-023281-47 |
Trial protocol |
DE HU SK BG |
Global completion date |
29 Aug 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 |
v1(current) |
This version publication date |
06 Jan 2017
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First version publication date |
06 Jan 2017
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Other versions |
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Summary report(s) |
EudraCT No. 2010-023281-47 Medical Journal Article |
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.