Clinical Trial Results:
A phase IIa, randomised, multicentre, evaluator-blinded, 4-way crossover clinical trial to study the pharmacokinetics, safety, tolerability and effects on lung function of one day treatment of formoterol 12 µg qd delivered by 2 different dry powder inhalers (Aerolizer® and Almirall Inhaler), of the Fixed Dose Combination formoterol 12 µg + Aclidinium bromide 200 µg qd delivered by Almirall Inhaler, and of formoterol 12 µg bid delivered by Aerolizer®, in moderate to severe Chronic Obstructive Pulmonary Disease Patients.
Summary
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EudraCT number |
2007-003648-31 |
Trial protocol |
DE |
Global completion date |
12 Dec 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 |
21 May 2016
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First version publication date |
21 May 2016
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Other versions |
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Summary report(s) |
Synopsis-M-273FO-22-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.