A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis

Summary

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.

Timeline

Start

2013-10-01

Primary completion

2014-02-04

Completion

2014-02-04

Outcome

Met primary endpoint

registry Placebo vs Levocabastine 400µg BID; p <0.0001; Mean Difference (Final Values) -1.350 (95% CI -1.943 to -0.756); Mixed Model ANOVA NCT01949051 ↗

registry Placebo vs Levocabastine 200µg OD; p = 0.0003; Mean Difference (Final Values) -1.118 (95% CI -1.712 to -0.525); Mixed Model ANOVA NCT01949051 ↗

paper difference in weighted mean TNSS (0-4 hours) following LEVO once-daily versus twice-daily was 0.23 units (95% CI -0.36, 0.82), demonstrating noninferiority PMID 26249767 ↗

Publications

• Murdoch RD, Bareille P, Ignar D, Mark S, Miller SR, Gupta A, Salapatek AM, Patel P. Once-daily dosing of levocabastine has comparable efficacy to twice-daily dosing in the treatment of allergic rhinitis assessed in an allergen challenge chamber. Int J Clin Pharmacol Ther. 2015 Oct;53(10):811-8. doi: 10.5414/CP202389.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levocabastine	Small molecule	200 ug	Intranasal
Subject	Levocabastine	Small molecule	400 ug	Intranasal

Indications