A Pilot Monocenter Study to Assess Cellular and Soluble Biomarkers in Nasal Secretions
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|ClinicalTrials.gov Identifier: NCT00297843|
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : June 19, 2007
Allergic Rhinitis is an inflammatory disease which causes an influx of inflammatory cells and cytokines into the nasal mucosa. These biomarkers can also be found in the nasal secretions. The evaluation of these inflammatory biomarkers is of great interest as this could lead to a concept of measuring the efficacy of anti-allergic treatments by assessing the changes in nasal biomarkers after allergen challenge. To use this model as an assessment of pharmacodynamics it is crucial to evaluate the specificity and reproducibility of cellular and cytokine levels in the nasal secretions after allergen provocations.
In a 2 part repeated measurement design 20 patients with allergic rhinitis and 20 healthy subjects will undergo two 4-hour pollen exposures in an interval of 21 days.
The aim of this study is to explore the cellular and cytokine levels this allergen challenge will induce in nasal secretions and to assess if an increase in those inflammatory biomarkers is specific to the patient subgroup and whether the results are reproducible after the second allergen challenge.
|Condition or disease||Intervention/treatment|
|Seasonal Allergic Rhinitis Healthy Subjects||Procedure: allergen challenge (grass pollen), nasal lavage|
|Study Type :||Observational|
|Enrollment :||40 participants|
|Official Title:||A Pilot Monocenter Study to Assess the Reproducibility and Specificity of Cellular and Soluble Biomarkers in Nasal Secretions in Patients With Allergic Rhinitis and Healthy Volunteers Following Pollen Exposure in the Fraunhofer Environmental Challenge Chamber (ECC)|
|Study Start Date :||March 2006|
|Study Completion Date :||May 2006|
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): NCT00297843
|Hannover, Germany, 30625|
|Principal Investigator:||Norbert Krug, MD||Fraunhofer ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany|