Clinical Trial Results:
A single dose, randomised, placebo-controlled, double-blind, 5-way crossover (employing an incomplete block design), efficacy (including 24-h pulmonary function tests) and safety comparison of Tiotropium/BI 54903 FDC ethanolic inhalation solution via Respimat® (doses of 1.23 µg/363.6 µg, 2.46 µg/363.6 µg or 4.93 µg/363.6 µg) versus free combination of Tiotropium aqueous inhalation solution via Respimat® (doses of 0, 2.5 µg, 5 µg or 10 µg) plus BI 54903 ethanolic inhalation solution via Respimat® (dose of 363.6 µg ) in patients with asthma.
Summary
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EudraCT number |
2011-001801-29 |
Trial protocol |
SK |
Global completion date |
11 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 |
06 Apr 2018
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First version publication date |
06 Apr 2018
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Other versions |
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Summary report(s) |
Statement |
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.