Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Last updated: April 14, 2021
Sponsor: Zagazig University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Common Cold

Allergy (Pediatric)

Allergy

Treatment

N/A

Clinical Study ID

NCT04851860
Allergic rhintis in children
  • Ages 6-12
  • All Genders

Study Summary

Better management and improving outcome of children with allergic rhinitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Children with moderate to severe allergic rhinitis according to Allergic RhinitisAnd Its Impact On Asthma (ARIA) guidelines[9], which interfere with daily activity orsleep.
  1. Children aged (6-12) years with clinical history of allergic rhinitis for at leastone year.
  2. Children with allergic rhinitis who failed medical treatment, desire an alternativeto pharmacotherapy.
  3. Sex : male and female.

Exclusion

Exclusion Criteria:

    1. Children with chronic lung & heart diseases as: asthma and anatomical malformation forrespiratory system.
  1. disorders: Gastro Esophageal Reflux Disease, cystic fibrosis and epilepsy. 3.Childrenwith chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.

Study Design

Total Participants: 30
Study Start date:
April 12, 2021
Estimated Completion Date:
November 20, 2021

Study 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.