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临床试验/NCT04813380
NCT04813380已完成3 期

Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients: Correlation With Disease Severity and Their Role as Biomarkers for Efficacy of Sublingual Immunotherapy

Zagazig University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年7月27日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
64
试验地点
2
主要终点
MiRNA146a, microRNA 223 measurements

研究概览

简要总结

The aim of the study is:

  • to evaluate the serum levels of miR-223 and miRNA146a and to assess their correlation with disease severity in allergic rhinitis patients and their role as biomarkers for efficacy of sublingual immunotherapy.
  • also to find if high sensitivity CRP can be an easy non-expensive test for diagnosis and follow up of allergic rhinitis patients.

详细描述

Over the last decades the prevalence of allergic disease has steadily been rising and recent figures indicate that in the western world 10-25% of people are affected with allergic diseases ranging from food allergy, atopic dermatitis/ eczema, allergic rhinitis, hay fever to asthma.

Allergic rhinitis (AR) is the most frequent allergic disease in Western Europe that interferes with school attendance and performance, with a prevalence rate of 20-30%. Very few studies of the epidemiology were done about the prevalence of allergic rhinitis in Egypt as its prevalence was 9 %.

Allergic rhinitis is allergen-specific IgE-mediated inflammatory reactions which is characterized by excessive eosinophil infiltration, Th2 cytokine responses such as IL5, IL4, IL13, and mucus secretion. The prevalence of allergic rhinitis is increasing worldwide due to changes in the socioeconomic status, environmental factor, and occupational factor. AR burden on sleep and learning is substantial in children. Moreover, AR is considered a risk factor for subsequent asthma comorbidity.

Allergic rhinitis is characterized by nasal congestion, itching, rhinorrhea, and sneezing, which are manifested as a consequence of inappropriate immune responses mediated by allergen specific immunoglobulin E (IgE) antibodies toward otherwise harmless antigens such as pollen and house dust mite (HDM).

High-sensitivity-C-reactive protein (hs-CRP) is a well-known systemic inflammatory marker that is easy and inexpensive to measure, together with ESR, serum Ig-E and total eosinophil count are measured as laboratory markers of allergic diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient consent.
  • Patients between 6-60 years old suffering from allergic rhinitis clinically.
  • Positive skin prick test

排除标准

  • 1- Chronic inflammatory condition as COPD, tuberculosis, aspergillosis and chronic hepatitis.
  • 2- Other allergic diseases as bronchial asthma, allergic conjunctivitis and chronic urticaria 3- Those undergoing chronic treatment with systemic steroids or B- blockers 4- Systemic immunological disorders as systemic lupus erythematous, rheumatoid arthritis and systemic sclerosis.
  • 5- Malignancy

结局指标

主要结局

MiRNA146a, microRNA 223 measurements

时间窗: 6 months

Effect of sublingual immunotherapy on the miRNA146, MicroRNA 223 on allergic rhinitis patients

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

Fatma Zohry Kamel Khater

Dr

Zagazig University

研究点 (2)

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