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

NCT ID: NCT00348361

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis

Keywords

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Hay fever biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Fluticasone Propionate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD,MSc, FPPM

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

London, London, United Kingdom

Site Status

Countries

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Netherlands United Kingdom

Other Identifiers

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ELR100710

Identifier Type: -

Identifier Source: org_study_id