Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients as Biomarkers for Efficacy of Sublingual Immunotherapy

December 18, 2022 updated by: Fatma Zohry Kamel Khater, Zagazig University

Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients: Correlation With Disease Severity and Their Role as Biomarkers for Efficacy of Sublingual Immunotherapy

The aim of the study is:

  • to evaluate the serum levels of miR-223 and miRNA146a and to assess their correlation with disease severity in allergic rhinitis patients and their role as biomarkers for efficacy of sublingual immunotherapy.
  • also to find if high sensitivity CRP can be an easy non-expensive test for diagnosis and follow up of allergic rhinitis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over the last decades the prevalence of allergic disease has steadily been rising and recent figures indicate that in the western world 10-25% of people are affected with allergic diseases ranging from food allergy, atopic dermatitis/ eczema, allergic rhinitis, hay fever to asthma.

Allergic rhinitis (AR) is the most frequent allergic disease in Western Europe that interferes with school attendance and performance, with a prevalence rate of 20-30%. Very few studies of the epidemiology were done about the prevalence of allergic rhinitis in Egypt as its prevalence was 9 %.

Allergic rhinitis is allergen-specific IgE-mediated inflammatory reactions which is characterized by excessive eosinophil infiltration, Th2 cytokine responses such as IL5, IL4, IL13, and mucus secretion. The prevalence of allergic rhinitis is increasing worldwide due to changes in the socioeconomic status, environmental factor, and occupational factor. AR burden on sleep and learning is substantial in children. Moreover, AR is considered a risk factor for subsequent asthma comorbidity.

Allergic rhinitis is characterized by nasal congestion, itching, rhinorrhea, and sneezing, which are manifested as a consequence of inappropriate immune responses mediated by allergen specific immunoglobulin E (IgE) antibodies toward otherwise harmless antigens such as pollen and house dust mite (HDM).

High-sensitivity-C-reactive protein (hs-CRP) is a well-known systemic inflammatory marker that is easy and inexpensive to measure, together with ESR, serum Ig-E and total eosinophil count are measured as laboratory markers of allergic diseases.

MicroRNAs (miRNAs) are small non-coding RNA molecules that are 18-22 nucleotides long and highly conserved throughout evolution. MiRNAs play important roles in numerous disease processes such as asthma and allergic rhinitis and that differential miRNA expression can identify novel subtypes of these diseases. As approximately 150 miRNAs are detectable in the blood, differential miRNA expression patterns may serve as a molecular fingerprint that aids in disease diagnosis, characterization, and prognosis.

MiRNAs may have particular clinical utility in allergic diseases. These diseases are characterized by tissue inflammation and are particularly difficult to diagnose and characterize considering that measuring releasing mediators, such as cytokines in blood which their characteristic measurement is unreliable . As a result, invasive methods (e.g., bronchoscopy and tissue biopsies) are needed to quantify inflammatory changes. It follows that miRNA expression profiling in blood and other body fluids becomes important for identifying and developing novel, non-invasive disease Biomarkers.

One of the most significantly upregulated molecules was miR-223 involved in eosinophilic inflammation and associated with lower regulatory T-cell numbers. It is well known that Treg cells play an important role in development of tolerance by producing IL-10. Thus, in the future inhibition of miR-223 could be considered an adjuvant treatment.

MiR-146a is one of the two members of the miR-146 miR family. It has been reported to be involved in a large number of cell activi¬ties, such as suppression of cancer growth, inhibition of inflam¬mation, regulation of the immune system and suppression of allergic inflammation. MiR-146a play a role in regulation of allergic diseases such as allergic rhinitis by modulating Treg cells.

Allergen-specific immunotherapy (AIT) is currently the only known causal effective treatment of IgE-mediated allergy. Sublingual immunotherapy is a well-established allergen-specific immunotherapy and a safe and effective strategy to reorient inappropriate immune responses in allergic patients.

MiR-146a may play a role in allergen immunotherapy of allergic diseases by modulating Treg cells. Also., high miR-223 expression is associated with lower regulatory T-cell numbers.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt, 44511
        • Fatma Zohry Kamel Khater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 56 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient consent.
  2. Patients between 6-60 years old suffering from allergic rhinitis clinically.
  3. Positive skin prick test

Exclusion Criteria:

  • 1- Chronic inflammatory condition as COPD, tuberculosis, aspergillosis and chronic hepatitis.

    2- Other allergic diseases as bronchial asthma, allergic conjunctivitis and chronic urticaria 3- Those undergoing chronic treatment with systemic steroids or B- blockers 4- Systemic immunological disorders as systemic lupus erythematous, rheumatoid arthritis and systemic sclerosis.

    5- Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oraltek Sublingual immunotherapy group
one drops under tongue for ten days then three Drops for another ten days then five drops for another ten days for three successive months then five drops every two days per week for two months then five drops one day per week for one months
Other: Sublingual immunotherapy
Sublingual immunotherapy give to allergic rhinitis patients for treatment
Placebo Comparator: Placebo
one drops under the tongue then three drops then five drops for three successive months then five drops every two days per week for two months then five drops one day per week for one months
Other: Sublingual immunotherapy
Sublingual immunotherapy give to allergic rhinitis patients for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MiRNA146a, microRNA 223 measurements
Time Frame: 6 months
Effect of sublingual immunotherapy on the miRNA146, MicroRNA 223 on allergic rhinitis patients
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Actual)

September 10, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

March 20, 2021

First Submitted That Met QC Criteria

March 20, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sublingual immunotherapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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