Clinical Trial Results:
A single dose, randomised, double blind, double dummy, placebo-controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of Formoterol-HFA pMDI 12 microgram per actuation administered by means of a "spacer" device (AeroChamber Plus) with that of Formoterol-HFA pMDI
12 microgram per actuation in 5- to 12-year-old children with persistent moderate to severe asthma
Summary
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EudraCT number |
2006-000907-41 |
Trial protocol |
HU |
Global completion date |
05 Oct 2006
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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
|
First version publication date |
06 Jan 2017
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Other versions |
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Summary report(s) |
EudraCT No. 2006-000907-41 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.