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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014