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Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in Allergic Rhinitis Patients

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT06137495
Collaborator
(none)
84
Enrollment
1
Location
1
Arm
30.9
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sensitization to House dust mites
 N/A

Detailed Description

All allergic rhinitits patients who were monosensitized to mixed HDMs, identified by SPT, will be subjected to complete history taking and assessment of the inclusion and exclusion criteria, performance of skin prick test and measurement of total serum IgE, measurement of specific IgE by Chemiluminescence Immunoassa, immunoblot assay and ImmunoCAP™ Phadiatop™. The patients will be followed-up for 6 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Immunoblot and Chemiluminescence Assays Versus ImmunoCap: Evaluation of Allergen Specific IgE in Egyptian House Dust Mites Allergic Rhinitis Patients
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Jun 30, 2023
Actual Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Allergic Rhinitis Patients

House dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) who were monosensitized to mixed HDMs, identified by SPT, is assayed using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard

Diagnostic Test: Sensitization to House dust mites
The SPT is performed at the time of diagnosis and after six-months follow-up period. Serum specific IgE is measured by immunoblotting, chemiluminescence, and ImmunoCAP assays
Other Names:
  • Allergen skin prick testing (SPT)
  • Measurement of serum specific IgE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of serum specific IgE [6 months from diagnosis to end of Follow-up period]

      Improvement of symptoms and signs of allergy

    2. Conversion of SPT to negative [6 months from diagnosis to end of Follow-up period]

      Improvement of symptoms and signs of allergy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient consent.

    2. Patient with (18-40) years age known to be allergic rhinitis.

    3. Patient with IgE mediated allergic rhinitis (positive total IgE).

    4. Patient with positive skin prick testing and monosensitized to HDM

    Exclusion Criteria:

    1. Patient refusal

    2. Patients taking oral corticosteroid.

    3. Patients taking anti-IgE injections.

    4. Patients taking intranasal corticosteroid.

    5. Patient with non- IgE mediated allergic rhinitis.

    6. Patients with chronic diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zagazig University Faculty of Medicine Zagazig Sharkia Egypt 44519

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Noha M Hammad, MD, Faculty of Medicine, Zagazig University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha M Hammad, MD, Associate Professor, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT06137495
    Other Study ID Numbers:
    • 6489-8-11-2020
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic

    Study Results

    No Results Posted as of Nov 22, 2023