Clinical Trial Results:
A comparison of the inflammatory control of asthma provided by one inhalation of Symbicort® Turbuhaler® 160/4.5 µg/inhalation b.i.d. plus as-needed versus one inhalation of Symbicort® Turbuhaler® 320/9 µg/inhalation b.i.d. + one inhalation of Pulmicort® Turbuhaler® 400 µg/dose b.i.d. plus Terbutaline Turbuhaler® 0.4 mg/inhalation as-needed. A 12-month, randomised, double-blind, parallel-group, active controlled, multinational, phase III B study in adult patients with asthma.
Summary
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EudraCT number |
2004-004042-41 |
Trial protocol |
DE SE GB ES DK |
Global completion date |
17 Mar 2007
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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 |
04 Jun 2016
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First version publication date |
04 Jun 2016
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Other versions |
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Summary report(s) |
D5890C00003_synopsis.pdf |
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.