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NCT Number: NCT06137495

Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in 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.

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Key information

Conditions

Diagnoses Disease

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Allergen skin prick testing (SPT), Measurement of serum specific IgE

Primary outcomes

  1. Reduction of serum specific IgE

    Time frame: 6 months from diagnosis to end of Follow-up period

    Improvement of symptoms and signs of allergy

  2. Conversion of SPT to negative

    Time frame: 6 months from diagnosis to end of Follow-up period

    Improvement of symptoms and signs of allergy

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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