A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis
Completed
GlaxoSmithKline
Phase 2
2013-10-01
This study will be a randomized, double blind, placebo controlled, 3-way cross over design in
allergic rhinitis subjects. Subjects will receive repeat doses of intra-nasal levocabastine
for 7 days in each period and the duration of the study will be about 13 weeks. An
Environmental Exposure Chamber (EEC) will be used in this study. The primary objective of the
study is to investigate the non-inferiority effect of 7 days treatment with levocabastine on
nasal symptoms elicited by an EEC when administered once daily (QD) compared with twice daily
(BID). Also study will be conducted to investigate the superiority of effect of 7 days
treatment with levocabastine (QD and BID) on nasal symptoms elicited by an EEC in subjects
compared to placebo.
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)
Completed
GlaxoSmithKline
Phase 2
2013-10-01
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.
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