Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

NCT ID: NCT04851860

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2021-11-20

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: OTHER

sublingual immunotherapy

Intervention Type: DRUG

sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma

Interventions

sublingual immunotherapy

sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Heba Mohammad Mahmoud Mahmoud Elnaggar

Doctor Heba

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad Romeh

Role: STUDY_DIRECTOR

Zagazig University

Central Contacts

Heba Elnaggar

Role: CONTACT

hebanagar77@gmail.com

00201018038288

Eman Elbehedy

Role: CONTACT

00201098177980

References

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.

Reference Type: RESULT

PMID: 27329923 (View on PubMed)

Other Identifiers

Allergic rhintis in children

Identifier Type: -

Identifier Source: org_study_id