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Repeat Nasal Allergen Challenge

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00290368
First received: February 10, 2006
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Imperial College London:

Estimated Enrollment: 22
Study Start Date: February 2006
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290368

Locations
United Kingdom
National Heart & Lung Institute Clinical Studies Unit
London, United Kingdom, SW3 6HP
Sponsors and Collaborators
Imperial College London
Novartis
Investigators
Principal Investigator: Trevor T Hansel, FRCPath Imperial College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00290368     History of Changes
Other Study ID Numbers: CPJMR0052104
Study First Received: February 10, 2006
Last Updated: September 7, 2006
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
 Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013