drugset / Trial / NCT00612820

A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR)

NCT00612820

Phase 2 Completed 55 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

Summary

This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.

Timeline

Start
2008-01
Primary completion
2008-05
Completion
2008-05

Publications

  • Background This study has not been published in the scientific literature.

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 100 ug Intranasal
Subject Fluticasone propionate Other / unclassified 200 ug Intranasal
Subject GSK256066 Small molecule 200 ug Intranasal