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Kinetics of Nasal Cytokine Responses to Mechanical Stimulation

NCT04878237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-13

No results posted yet for this study

Summary

IgE-associated allergy is a hypersensitivity disease affecting more than 40% of the population in industrialised countries. Recently the kinetics of change of clinical and immunological parameters (e.g. nasal blockage and cytokine profiles) in response to allergen exposure have been described. Additionally through recent placebo controlled studies it has become clear that the response of certain cytokines can not only be triggered by allergen exposure but also mechanically e.g through the insertion of nasal swabs for collection of cytokines. However it is not clear to what extent the mechanically triggered cytokine responses may differ between healthy, allergic and asthmatic patients who have been shown to have different cytokine profiles in their nasal secretions and varying impairment of their respiratory epithelium. As collection devices for nasal secretions are frequently used in clinical studies, the investigators aim to assess the impact of mechanical stimulation by frequent cytokine sampling on the cytokine profile.

Conditions

  • Allergic Rhinitis Due to Grass Pollen
  • Allergic Asthma

Interventions

OTHER

Nasal Secretion Sampling

Nasal specimen collection will be performed at all visits. For every visit specimens will be collected using nasosorption FXi/PU (containing a synthetic absorptive matrix (SAM)), or a 10 cm-long plastic curette (nasosorption devices from Hunt Developments, UK) (Curette devices from Arlington Scientific, USA)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Sven Schneider, MD · Attending ENT Specialist

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Austria

Study Locations

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Entities

Companies

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 NCT04878237 on ClinicalTrials.gov