Repeat Nasal Allergen Challenge - Full Text View

Sponsors and Collaborators:	Imperial College London Novartis
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00290368

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 II

MedlinePlus related topics: Hay Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Bio-equivalence Study
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

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:

Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years.
Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.

Exclusion Criteria:

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

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

Keywords provided by Imperial College London:

Nasal allergen challenge
Allergic rhinitis
Timothy grass pollen
inflammatory mediators

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009