Clinical Trial Results:
A 6-month, double-blind, double-dummy, randomised, parallel group, multicenter, efficacy and safety study of Symbicort® pMDI 2x160/4.5μg and 2x80/4.5μg bid compared to Formoterol Turbuhaler, Budesonide pMDI (& the combination) and Placebo in chronic obstructive pulmonary disease patients (COPD).
Summary
|
|
EudraCT number |
2004-001183-41 |
Trial protocol |
CZ |
Global completion date |
28 Dec 2006
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
05 Jun 2016
|
First version publication date |
05 Jun 2016
|
Other versions |
|
Summary report(s) |
D5899C00002_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.