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

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137495
• Other study ID #: 6489-8-11-2020
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnoses Disease
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Egypt	Zagazig University Faculty of Medicine	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of serum specific IgE	Improvement of symptoms and signs of allergy	6 months from diagnosis to end of Follow-up period
Primary	Conversion of SPT to negative	Improvement of symptoms and signs of allergy	6 months from diagnosis to end of Follow-up period