Clinical Trial Results:
A randomised, 4-week, placebo-controlled, double-blind, 6 arm parallel group, dose-finding clinical trial, to assess the efficacy and safety of three different doses of formoterol (6, 12 & 18µg) combined with the inhaled anticholinergic aclidinium bromide 200µg, aclidinium bromide 200µg monotherapy and formoterol 12µg monotherapy all administered once daily by inhalation via Almirall inhaler in patients with stable moderate to severe Chronic Obstructive Pulmonary Disease.
Summary
|
|
EudraCT number |
2007-004435-30 |
Trial protocol |
CZ HU SK |
Global completion date |
10 Nov 2008
|
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 |
21 May 2016
|
First version publication date |
21 May 2016
|
Other versions |
|
Summary report(s) |
Synopsis-m-273FO-23-Final |
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.