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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

February 10, 2006
September 7, 2006
February 2006
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• To test the hypothesis that repeated nasal allergen challenge in allergic rhinitis patients leads to an increase in IL-13 in nasal exudate beyond that achieved after a single challenge. This will enable the feasibility of repetitive nasal allergen app
Complete list of historical versions of study NCT00290368 on ClinicalTrials.gov Archive Site
Not Provided
  • • To establish and validate important biomarkers
  • • To detect levels of soluble mediators following single and repeated nasal allergen challenge, with a focus on Th2-associated cytokines
  • • To enumerate eosinophils in nasal lavages following single and repeated nasal allergen challenges
  • • To compare Total Nasal Symptom Scores (TNSS) following single and repeated nasal allergen challenges
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Repeat Nasal Allergen Challenge
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hayfever
  • Procedure: Skin Prick Test
  • Procedure: Nasal allergen challenge
  • Procedure: Nasal filter paper placement
  • Procedure: Nasal lavage
  • Procedure: Nasal scrape
  • Procedure: Nasal symptoms score
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2006
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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).
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00290368
CPJMR0052104
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Not Provided
Imperial College London
Novartis
Principal Investigator: Trevor T Hansel, FRCPath Imperial College London
Imperial College London
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP