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

Not Applicable

Completed

• Conditions: Diagnoses Disease
• Interventions: Diagnostic Test: Sensitization to House dust mites

• Registration Number: NCT06137495
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Study Start: 2020-12-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allergic Rhinitis Patients	Sensitization to House dust mites	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

Primary Outcome Measures

Name	Time	Method
Reduction of serum specific IgE	6 months from diagnosis to end of Follow-up period	Improvement of symptoms and signs of allergy
Conversion of SPT to negative	6 months from diagnosis to end of Follow-up period	Improvement of symptoms and signs of allergy

Trial Locations

Locations (1)

Zagazig University Faculty of Medicine; 🇪🇬 Zagazig, Sharkia, Egypt