NCT00377728

Trial With Rhinitic Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber

A 14 Day, Randomised, Double Blinded, Placebo-controlled 2-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Placebo in an Environmental Exposition Unit (Vienna Challenge Chamber) in Subjects With Seasonal Allergic Rhinitis (SAR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study is in patients with seasonal allergic rhinitis(SAR)and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in development by GSK for the treatment of allergic rhinitis, asthma and COPD. Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used. Opportunity to assess the efficacy of compounds versus placebo at maximal and trough plasma concentrations. This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo. 12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.

Conditions

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	GSK256066

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2006-09-18
• Last updated: 2015-04-15

Locations

1 site across 1 country: Austria