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

GlaxoSmithKline48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

Fluticasone PropionateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

GSK Investigational Site

Amsterdam, Netherlands

GSK Investigational Site

London, London, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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