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

Primary Purpose

Effects of Immunotherapy

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sublingual immunotherapy
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Effects of Immunotherapy focused on measuring Allergen immunotherapy, MiRNA-223, MiRNA-146a

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fatma Zohry Kamel Khater

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oraltek Sublingual immunotherapy group

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

MiRNA146a, microRNA 223 measurements
Effect of sublingual immunotherapy on the miRNA146, MicroRNA 223 on allergic rhinitis patients

Secondary Outcome Measures

Full Information

First Posted
March 20, 2021
Last Updated
December 18, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04813380
Brief Title
Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients as Biomarkers for Efficacy of Sublingual Immunotherapy
Official Title
Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients: Correlation With Disease Severity and Their Role as Biomarkers for Efficacy of Sublingual Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
September 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of Immunotherapy
Keywords
Allergen immunotherapy, MiRNA-223, MiRNA-146a

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oraltek Sublingual immunotherapy group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Sublingual immunotherapy
Intervention Description
Sublingual immunotherapy give to allergic rhinitis patients for treatment
Primary Outcome Measure Information:
Title
MiRNA146a, microRNA 223 measurements
Description
Effect of sublingual immunotherapy on the miRNA146, MicroRNA 223 on allergic rhinitis patients
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient consent. Patients between 6-60 years old suffering from allergic rhinitis clinically. 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
Facility Information:
Facility Name
Fatma Zohry Kamel Khater
City
Zagazig
ZIP/Postal Code
44511
Country
Egypt

12. IPD Sharing Statement

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17765078
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Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients as Biomarkers for Efficacy of Sublingual Immunotherapy

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