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

November 19, 2023 updated by: Noha M Hammad, MD, Zagazig University

Immunoblot and Chemiluminescence Assays Versus ImmunoCap: Evaluation of Allergen Specific IgE in Egyptian House Dust Mites Allergic Rhinitis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of serum specific IgE
Time Frame: 6 months from diagnosis to end of Follow-up period
Improvement of symptoms and signs of allergy
6 months from diagnosis to end of Follow-up period
Conversion of SPT to negative
Time Frame: 6 months from diagnosis to end of Follow-up period
Improvement of symptoms and signs of allergy
6 months from diagnosis to end of Follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6489-8-11-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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