Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Allergic Rhinitis Clinical Trial

Official title:

Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04851860
• Other study ID #: Allergic rhintis in children
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 12, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: April 2021
• Source: Zagazig University
• Contact: Heba Elnaggar
• Phone: 00201018038288
• Email: hebanagar77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Better management and improving outcome of children with allergic rhinitis

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 20, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline