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A Pilot Monocenter Study to Assess Cellular and Soluble Biomarkers in Nasal Secretions

NCT00297843 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2007-06-19

No results posted yet for this study

Summary

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.

Conditions

  • Seasonal Allergic Rhinitis
  • Healthy Subjects

Interventions

PROCEDURE

allergen challenge (grass pollen), nasal lavage

Sponsors & Collaborators

  • Fraunhofer-Institute of Toxicology and Experimental Medicine

    lead OTHER

Principal Investigators

  • Norbert Krug, MD · Fraunhofer ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Completion
2006-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00297843 on ClinicalTrials.gov