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临床试验/NCT04851860
NCT04851860Unknown3 期

Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children

Zagazig University0 个研究点目标入组 30 人开始时间: 2021年4月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
30
主要终点
measurement of serum level of platlet factor 4 before and after sublingual immunotherapy

研究概览

简要总结

Better management and improving outcome of children with allergic rhinitis

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.
  • Children aged (6-12) years with clinical history of allergic rhinitis for at least one year.
  • Children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy.
  • Sex : male and female.

排除标准

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

研究组 & 干预措施

allergic rhintis children

Other

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 .

干预措施: sublingual immunotherapy (Drug)

结局指标

主要结局

measurement of serum level of platlet factor 4 before and after sublingual immunotherapy

时间窗: baseline

diffrentiate serum level of platlet factor4 in children with allergic rhintis before and after treatment with sublingual immunotherapy

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Heba Mohammad Mahmoud Mahmoud Elnaggar

Doctor Heba

Zagazig University

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