Clinical Trial Results:
Randomised, double-blind, triple dummy, partial cross-over (each active treatment with placebo) study using an Environmental Challenge Chamber (ECC) to assess the safety and efficacy of 2 weeks of oral BI 671800 ED 50, 200 or 400 mg bid, compared to montelukast 10 mg qd, fluticasone propionate nasal spray 200 µg qd (2 nasal actuations each nostril of 50 µg) versus placebo in seasonal allergic rhinitis patients out of season, sensitive to Dactylis glomerata.
Summary
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EudraCT number |
2009-013269-24 |
Trial protocol |
DE |
Global completion date |
03 May 2010
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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 |
10 Mar 2016
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First version publication date |
10 Mar 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.