Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00348361

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Fluticasone Propionate	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Diagnostic

Official Title:

A Study to Validate Key Therapeutic Targets and Biomarkers During Allergen Exposure in Subjects With Allergic Rhinitis

Study Start Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Change in expression of key allergy targets in the nose following exposure to allergen. Assessment of protein expression measured by western blotting and immunohistochemistry in nasal biopsy tissue. []

Secondary Outcome Measures

Effect of corticosteroids treatment on the change in target expression following allergen challenge. Nasal lavage fluid and nasal secretions will be measured by ELISA and chemiluminescent assay. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

No signs or symptoms of rhinitis outside of the relevant airborne allergen season.

Exclusion criteria:

History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.
Symptoms of rhinitis at inclusion indicated by total VAS score of >40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score >20.
Subjects not showing a nasal response to allergen concentration =< 10,000 BU/ml.
Subjects with positive skin prick test for Dust House Mite.