Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

April 14, 2021 updated by: Heba Mohammad Mahmoud Mahmoud Elnaggar, Zagazig University
Better management and improving outcome of children with allergic rhinitis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevelance of Allergic Respiratory Diseases has been increased worldwide and affect 1of 5 persons of general population . ARDs are triggered by exposure to allergen and includes allergic rhinitis with or without conjunctivitis and bronchial asthma. ARDs are associated with decreased quality of life and increased economic burden .

Allergen-specific immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma, and its efficacy has long been known since observations by Leonard Noon in 1911. Allergen immunotherapy for AR is currently considered when showing strongly suggestive symptoms of AR which interfere with daily activities or sleep, and having evidence of IgE sensitization to ≥1 clinically relevant allergen .

The European Academy of Allergy and Clinical Immunology (EAACI) recommends treatmentof children with moderate to severe AR with Allergen Immunotherapy. It includes sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT).Subcutaneous immunotherapy (SCIT) has been the gold standard, whereas sublingual immunotherapy (SLIT) has emerged as an effective and safe alternative .

Sublingual immunotherapy (SLIT) is the only treatment that regulates the immunological process during development of allergic rhinitis (AR), rather than simply treating symptoms.

Platelet activation occurs during antigen-induced airway reactions in allergic and asthmatic subjects. Raised levels of platelet-derived mediators, such as the Platelet Factor-4 (PF4), it is observed in plasma and bronchoalveolar lavage fluid of atopic individuals, and has the ability to activate eosinophils, increase expression of Fc-IgG and Fc-IgE receptors, and stimulate basophils to release histamine.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Contact Backup

  • Name: Eman Elbehedy
  • Phone Number: 00201098177980

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

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Children with moderate to severe allergic rhinitis according to Allergic Rhinitis And Its Impact On Asthma (ARIA) guidelines[9], which interfere with daily activity or sleep.

    2. Children aged (6-12) years with clinical history of allergic rhinitis for at least one year.

    3. Children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy.

    4. Sex : male and female.

Exclusion Criteria:

- 1. Children with chronic lung & heart diseases as: asthma and anatomical malformation for respiratory system.

2. disorders: Gastro Esophageal Reflux Disease, cystic fibrosis and epilepsy. 3.Children with chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: allergic rhintis children
sublingual immunotherapy is used for allergic rhintis children by dosing Allergen immunotherapy extract as sublingual drops which were kept under the tongue for a couple of minutes and then swallowed. The sublingual drops were administered in the morning on an empty stomach .
sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of serum level of platlet factor 4 before and after sublingual immunotherapy
Time Frame: baseline
diffrentiate serum level of platlet factor4 in children with allergic rhintis before and after treatment with sublingual immunotherapy
baseline

Collaborators and Investigators

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

Investigators

  • Study Director: Mohammad Romeh, 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.

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 (ANTICIPATED)

April 12, 2021

Primary Completion (ANTICIPATED)

October 15, 2021

Study Completion (ANTICIPATED)

November 20, 2021

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (ACTUAL)

April 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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