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Repeat Nasal Allergen Challenge

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ClinicalTrials.gov Identifier: NCT00290368
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : October 22, 2015
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Imperial College London

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
Hayfever 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
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 : February 2006
Estimated Study Completion Date : May 2006




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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290368


Locations
United Kingdom
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

ClinicalTrials.gov Identifier: NCT00290368     History of Changes
Other Study ID Numbers: CPJMR0052104
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: September 2006

Keywords provided by Imperial College London:
Nasal allergen challenge
Allergic rhinitis
Timothy grass pollen
inflammatory mediators