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

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

This study has been completed.

Study NCT00348361. Last updated on October 9, 2008. Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study

Primary Outcome Measure ^†

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 Measure ^†

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.

Condition ^†

Allergic Rhinitis

Intervention ^†

Drug: Fluticasone Propionate

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

April 2005

Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Netherlands, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00348361

Organization ID

ELR100710

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD,MSc, FPPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

First Received Date ^†

June 30, 2006

Last Updated Date

October 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.