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临床试验/NCT05786638
NCT05786638已完成不适用

Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma

Mansoura University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Total Ig E

研究概览

简要总结

Asthma is characterized by airway inflammation and is manifested by acute episodes of obstruction related to loss of control of airway inflammation mostly in response to a viral respiratory tract infection .The significance of eosinophilic inflammation in asthma is well established.

Late clinical reactions in asthma are associated with increase of immunoglobulin E (IgE) in serum. Serum IgE can be used as a measure of allergen provocation causing increased eosinophil activity. Serum IgE can be used to assess the exposure to environmental allergens, or decreasing presence of allergen in the environment and the need for increase or reduction of therapy.

Allergen immunotherapy is defined as the repeated administration of specific allergens to patients with IgE-mediated conditions for the purpose of providing protection against the allergic symptoms and inflammatory reactions associated with natural exposure to these allergens.

The aim of this work is to evaluate the effect of sublingual versus subcutaneous allergen immunotherapy as regard clinical response, serum IgE and sputum eosinophils

详细描述

study was conducted in Mansoura University Hospitals, Chest Medicine Department on patients attended to Asthma and Allergy clinic. The asthma symptoms and leukotrienes antagonist, inhaled B2 agonist, inhaled steroid and systemic steroid usage recorded throughout the study period. Venous blood and sputum samples were collected before and at the end of the study for determination of IgE and sputum eosinophil levels respectively. Fifty asthmatic patients recruited from Mansoura university allergy outpatient clinic were included before treatment with subcutaneous immunotherapy (SCIT) vaccines and another Fifty asthmatic patients were included before treatment with sublingual immunotherapy (SLIT) vaccines. In this study, All of patients were symptomatic and on medications either bronchodilators or inhaled corticosteroids (ICS). All patients were diagnosed by previous pulmonary function test (PFT) with reversibility test and follow up with our outpatient clinic (OPC). Each patient underwent spirometry to determine forced expiratory volume at 1st second (FEV1) and to ensure that his condition is stable before starting immunotherapy. Serum IgE and sputum eosinophil count were measured in 100 patients with asthma before and after 6 , 12 , 18 months of treatment with immunotherapy vaccines.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • New cases of allergic asthma indicated for immunotherapy (partially controlled by medical treatment with frequent exacerbations)
  • Age >18 years

排除标准

  • Pregnancy
  • Co morbidity such as diabetes, hypertension, ischemic heart, malignancy
  • Other causes of the increase in eosinophil as: parasitic infestation
  • Acute exacerbation of BA
  • Severe persistent asthma

研究组 & 干预措施

Sublingual immunotherapy

Active Comparator

50 Bronchial asthma (BA) patients received Sublingual immunotherapy

干预措施: Allergen Immunotherapy Extract (Drug)

Subcutaneous immunotherapy

Active Comparator

50 BA patients received Subcutaneous immunotherapy

干预措施: Allergen Immunotherapy Extract (Drug)

结局指标

主要结局

Total Ig E

时间窗: After18 month

Measure Total igE after 18 months post immunotherapy

Sputum eosinophil

时间窗: After 18 month

Measure Sputum eosinophil after 18 months post immunotherapy

次要结局

未报告次要终点

研究者

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

Mohamed Abd Elmoniem Mohamed

Assistant lecturer

Mansoura University Hospital

研究点 (1)

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