NCT01949051

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

A Randomized, Double-blind, Placebo Controlled, 3 Way Cross Over Study in Subjects With Allergic Rhinitis to Assess the Effect of Intranasal Repeat Doses of Levocabastine When Administered Once Daily or Twice Daily on the Symptoms of Rhinitis in an Allergen Challenge Chamber

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Perennial and Seasonal

Interventions

Type	Name	Description
DRUG	Levocabastine	Intranasal aqueous 50 mcg microsuspension of levocabastine supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension
DRUG	Placebo	Intranasal aqueous 0 mcg microsuspension supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-02-04
• Completion: 2014-02-04
• First posted: 2013-09-24
• Last updated: 2017-06-06
• Results posted: 2014-09-25

Locations

1 site across 1 country: Canada