A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis
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.
Rhinitis, Allergic, Perennial and Seasonal
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Total Nasal Symptom Score (TNSS) for levocabastine administered QD compared to BID [ Time Frame: Day 8 of each study period ] [ Designated as safety issue: No ]TNSS will be measured after 7 days of treatment when administered QD will be compared to BID measured at 24 hours and 12 hours respectively) after the last active dose on Day 7
- TNSS for levocabastine compared to placebo [ Time Frame: Day 8 of each study period ] [ Designated as safety issue: No ]TNSS will be measured for levocabastine compared to placebo measured at after the last dose on Day 7.
- Tolerability assessment of intranasal levocabastine for TNSS individual components [ Time Frame: Day 8 of each study period ] [ Designated as safety issue: No ]Nasal symptoms (nasal congestion, rhinorrhoea, nasal itch and sneeze) will be scored on a categorical scale from 0 to 3. TNSS will be calculated as the sum of the response for nasal congestion, nasal itch, sneeze and rhinorrhoea, with a maximum score of 12.
|Study Start Date:||October 2013|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Levocabastine Arm
Subjects will be assigned to one of six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) in accordance with the randomisation schedule. A = Two, 50 microgram (mcg) sprays per nostril of levocabastine QD in the morning. Total dose of 200 mcg. Two, 0 mcg sprays from placebo to match vehicle in the evening; B = Two, 50 mcg sprays per nostril of levocabastine BID in the morning and evening. Total dose of 400 mcg; C = Two, 0 mcg sprays per nostril from placebo vehicle in morning and evenings.
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 suspensionDrug: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01949051
|GSK Investigational Site|
|Mississauga, Ontario, Canada, L4W 1A4|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|