Clinical Trial Results:
A 26 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 μg pMDI (FIXED COMBINATION OF EXTRAFINE FORMULATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 μg pMDI (FIXED COMBINATION OF EXTRAFINE FORMULATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN SUBJECTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG-ACTING ß2-AGONISTS.
Summary
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EudraCT number |
2021-002391-39 |
Trial protocol |
HU DE SK CZ BG PL IT LV ES FI GR NL BE FR |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jun 2025
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First version publication date |
01 Jun 2025
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Other versions |
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Summary report(s) |
CLI-05993AB1-06 Study CSR 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.