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Innate Immunity in Allergic Asthma

Sponsor
University of Central Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT06068335
Collaborator
(none)
100
Enrollment
1
Location
31.4
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether a potential type 2 signature, obtained through stimulation of cell lines with various allergens in vitro, correlates with an allergic or asthmatic disease state ex vivo. This type 2 signature will be multi-hierarchical in nature and will be comprised cell surface receptor expression, pathway activation, and gene upregulation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Innate Immunity in Allergic Asthma
    Actual Study Start Date :
    Oct 18, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. determine which parameters of the established type-2 signature obtained in vitro is significantly different 5 between healthy controls, allergic individuals, and asthmatic individuals ex vivo. [1 year]

    Secondary Outcome Measures

    1. o determine ex vivo whether any of the identified disease-specific type-2 parameters can be modified (brought back to healthy control levels) through the use of investigational compounds. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Participants must be at least 18 years of age

    • no history of allergic disease (healthy controls), have clinically diagnosed allergies, or have clinically diagnosed asthma.

    Exclusion Criteria:

    • Pregnant women and prisoners will be excluded from the study.

    • Individuals currently suffering from any acute infections and those known to suffer from light-headedness will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Central Florida Orlando Florida United States 32816

    Sponsors and Collaborators

    • University of Central Florida

    Investigators

    • Principal Investigator: Justine T Tigno-Aranjuez, PhD, University of Central Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Central Florida
    ClinicalTrials.gov Identifier:
    NCT06068335
    Other Study ID Numbers:
    • CR00001150
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 5, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Central Florida
    allergy
    Immunity
    Healthy
    respiratory
    ENT
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Oct 5, 2023