A Proof of Concept Study to Assess Effect of Fluticasone Furoate (FF)/Levocabastine Fixed Dose Combination (FDC) Compared With Levocabastine and FF Alone in Subjects With Allergic Rhinitis (AR)

Summary

This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block crossover study to evaluate the effect of single and repeat doses of levocabastine, FF, placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study duration for each individual participating in the study will be a maximum of up to 20 weeks (including the screening and follow-up). This will be a three period study and subjects will be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days between two treatment periods. The rational for this study is to demonstrate proof of concept with the FDC of FF and levocabastine compared with each of the components administered alone.

Timeline

Start

2013-10

Primary completion

2014-02

Completion

2014-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs FF 100 μg/Levo 200 μg; p <0.0001; Mean Difference (Final Values) -4.097 (95% CI -4.857 to -3.337); Mixed Model ANOVA NCT01957202 ↗

paper After 8 days, FDC resulted in both statistically and clinically significant reductions in mean TNSS compared with FF and LEVO alone PMID 25900517 ↗

Publications

• Murdoch RD, Bareille P, Ignar D, Miller SR, Gupta A, Boardley R, Zieglmayer P, Zieglmayer R, Lemel P, Horak F. The improved efficacy of a fixed-dose combination of fluticasone furoate and levocabastine relative to the individual components in the treatment of allergic rhinitis. Clin Exp Allergy. 2015 Aug;45(8):1346-55. doi: 10.1111/cea.12556.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone Furoate	Other / unclassified	100 ug	Intranasal
Subject	Levocabastine	Small molecule	200 ug	Intranasal

Indications