Clinical Trial Results:
A single dose, placebo-controlled, randomised, double-blind double dummy, 5-way crossover (7 treatments, 5 periods incomplete block), including 24-h pulmonary function tests, pharmacodynamic comparison of olodaterol/BI 54903 fixed dose combination inhalation solutions via Respimat® (including clinical doses of 1.23/363.6 μg, 2.46/363.6 μg and 4.93/363.6 μg) versus free combinations of olodaterol inhalation solutions (0, 2.5 μg, 5 μg and 10 μg) via Respimat® plus BI 54903 inhalation solution (363.6 μg ) in patients with asthma
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
Summary
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EudraCT number |
2011-000935-98 |
Trial protocol |
DE |
Global completion date |
14 Nov 2011
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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 |
12 Nov 2016
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First version publication date |
12 Nov 2016
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Other versions |
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Summary report(s) |
Trial 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.