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Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Primary Purpose

Allergic Rhinitis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sublingual immunotherapy
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    allergic rhintis children

    Arm Description

    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 .

    Outcomes

    Primary Outcome Measures

    measurement of serum level of platlet factor 4 before and after sublingual immunotherapy
    diffrentiate serum level of platlet factor4 in children with allergic rhintis before and after treatment with sublingual immunotherapy

    Secondary Outcome Measures

    Full Information

    First Posted
    April 14, 2021
    Last Updated
    April 14, 2021
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04851860
    Brief Title
    Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children
    Official Title
    Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 12, 2021 (Anticipated)
    Primary Completion Date
    October 15, 2021 (Anticipated)
    Study Completion Date
    November 20, 2021 (Anticipated)

    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
    Better management and improving outcome of children with allergic rhinitis
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    allergic rhintis children from 6 to12 years
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    allergic rhintis children
    Arm Type
    Other
    Arm Description
    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 .
    Intervention Type
    Drug
    Intervention Name(s)
    sublingual immunotherapy
    Intervention Description
    sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma
    Primary Outcome Measure Information:
    Title
    measurement of serum level of platlet factor 4 before and after sublingual immunotherapy
    Description
    diffrentiate serum level of platlet factor4 in children with allergic rhintis before and after treatment with sublingual immunotherapy
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba Elnaggar
    Phone
    00201018038288
    Email
    hebanagar77@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Elbehedy
    Phone
    00201098177980
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Romeh
    Organizational Affiliation
    Zagazig University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27329923
    Citation
    Chen Y, Zhou L, Yang Y. Effect of sublingual immunotherapy on platelet activity in children with allergic rhinitis. Braz J Otorhinolaryngol. 2017 Mar-Apr;83(2):190-194. doi: 10.1016/j.bjorl.2016.03.006. Epub 2016 Apr 22.
    Results Reference
    result

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    Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

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