Last updated: 11/04/2018 06:36:37

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

GSK study ID
ELR100710
See study documents
Clinicaltrials.gov ID
NCT00348361
EudraCT ID
2004-002872-41
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Study to Validate Key Therapeutic Targets and Biomarkers during Allergen Exposure in Subjects with Allergic Rhinitis
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone Propionate
    • Enrollment:
    48
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Allergic Rhinitis
    Product
    fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    April 2005 to May 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    no
    • Inclusion criteria:
    • No signs or symptoms of rhinitis outside of the relevant airborne allergen season.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, London, United Kingdom, WC1X 8DA
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    AMSTERDAM, Netherlands, 1105 AZ
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-06-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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