NCT00612820

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	GSK256066	200mcg bd,
DRUG	fluticasone propionate	200mcg od,100mcg bd

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-02-12
• Last updated: 2016-11-03

Locations

1 site across 1 country: Austria