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Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04851860
Enrollment
30
Registered
2021-04-21
Start date
2021-04-12
Completion date
2021-11-20
Last updated
2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

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.

Interventions

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

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

allergic rhintis children from 6 to12 years

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Contacts

Primary ContactHeba Elnaggar
hebanagar77@gmail.com00201018038288
Backup ContactEman Elbehedy
00201098177980

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026