drugset / Trial / NCT00612118

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

NCT00612118

Phase 2 Completed 70 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2008-02
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Azelastine Small molecule 140 ug Intranasal
Subject GSK256066 Small molecule 200 ug Intranasal