Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Phase 3

• Conditions: Allergic Rhinitis
• Interventions: Drug: sublingual immunotherapy

• Registration Number: NCT04851860
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-12
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-21
• Last Update Posted: 2021-04-21
• Primary Completion: 2021-10-15
• Study Completion: 2021-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
allergic rhintis children	sublingual immunotherapy	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 .

Primary Outcome Measures

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