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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348361
• Other study ID #: ELR100710
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2006
• Last updated: October 9, 2008
• Start date: April 2005

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Fluticasone Propionate

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Amsterdam
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.