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

NCT06137495 | Completed

• 1 other identifier: 6489-8-11-2020
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnoses Disease

Outcome Measures

Primary Outcomes (2)

• Reduction of serum specific IgE

  Improvement of symptoms and signs of allergy

  6 months from diagnosis to end of Follow-up period

• Conversion of SPT to negative

  Improvement of symptoms and signs of allergy

  6 months from diagnosis to end of Follow-up period

Study Arms (1)

Allergic Rhinitis Patients

EXPERIMENTAL

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

Interventions

Sensitization to House dust mites DIAGNOSTIC_TEST

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

Also known as: Allergen skin prick testing (SPT), Measurement of serum specific IgE

Allergic Rhinitis Patients

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient consent.
• Patient with (18-40) years age known to be allergic rhinitis.
• Patient with IgE mediated allergic rhinitis (positive total IgE).
• Patient with positive skin prick testing and monosensitized to HDM

You may not qualify if:

• Patient refusal
• Patients taking oral corticosteroid.
• Patients taking anti-IgE injections.
• Patients taking intranasal corticosteroid.
• Patient with non- IgE mediated allergic rhinitis.
• Patients with chronic diseases.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

Study Officials

• Noha M Hammad, MD

  Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)