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Repeat Nasal Allergen Challenge

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT00290368
Collaborator
Novartis Pharmaceuticals (Industry)
22
Enrollment
1
Location
2.9
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Skin Prick Test
  • Procedure: Nasal allergen challenge
  • Procedure: Nasal filter paper placement
  • Procedure: Nasal lavage
  • Procedure: Nasal scrape
  • Procedure: Nasal symptoms score
 Phase 2

Detailed Description

This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Inflammatory Mediator and Cellular Changes Following Repeated Nasal Allergen Challenge in Subjects With Allergic Rhinitis Sensitive to Timothy Grass Pollen - a Validation Study
Study Start Date :
Feb 1, 2006
Study Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years.

    2. Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.

    Exclusion Criteria:

    1. Smokers (use of tobacco products in the previous 3 months).

    2. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 > 80% predicted at screening).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Heart & Lung Institute Clinical Studies Unit London United Kingdom SW3 6HP

    Sponsors and Collaborators

    • Imperial College London
    • Novartis Pharmaceuticals

    Investigators

    • Principal Investigator: Trevor T Hansel, FRCPath, Imperial College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00290368
    Other Study ID Numbers:
    • CPJMR0052104
    First Posted:
    Feb 13, 2006
    Last Update Posted:
    Oct 22, 2015
    Last Verified:
    Sep 1, 2006
    Keywords provided by , ,
    Nasal allergen challenge
    Allergic rhinitis
    Timothy grass pollen
    inflammatory mediators
    Additional relevant MeSH terms:
    Rhinitis, Allergic, Seasonal

    Study Results

    No Results Posted as of Oct 22, 2015