NCT00612118

A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis

A Randomised, Double Blind, 2-way Crossover Trial of 8 Days Repeat Dosing With Intranasal GSK256066 and Azelastine Hydrochloride in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, and allergen challenge assessments will also be performed at various time points throughout the study.

Conditions

• Allergic Rhinitis
• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	GSK256066	200mcg bd
DRUG	azelastine hydrochloride	140mcg

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-02-11
• Last updated: 2012-06-05

Locations

1 site across 1 country: Austria