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

NCT ID: NCT06137495

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diagnoses Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sensitization to House dust mites

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Allergen skin prick testing (SPT) Measurement of serum specific IgE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Noha M Hammad, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha M Hammad, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Zagazig University

Locations

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Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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6489-8-11-2020

Identifier Type: -

Identifier Source: org_study_id