Clinical Trial Results:
Estudio Fase IV, multinacional, multicéntrico, doble ciego, doble simulación, randomizado, de grupos paralelos, controlado, sobre la combinación de dosis fijas de Dipropionato de Beclometasona 100 µg más Fumarato de Formoterol 6 µg pMDI con propelente HFA-134A (CHF1535, FOSTER®) versus Fluticasona 250 µg más Salmeterol 50 µg IPS (SERETIDE® DISKUS®) como tratamiento de mantenimiento de pacientes asmáticos controlados.
A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS.
Summary
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EudraCT number |
2008-003740-11 |
Trial protocol |
ES NL DE FR |
Global completion date |
30 Sep 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 |
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. 2008-004671-22 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.