Early Changes in Eosinophil Cationic Protein and Sputum Eosinophils Following Subcutaneous Allergen Immunotherapy in Allergic Asthma: A Prospective Cohort Study
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
- Clinical response
研究概览
简要总结
Asthma is a chronic heterogeneous inflammatory airway disease affecting millions worldwide and remains a major global health burden. Despite advances in pharmacological therapy, a substantial proportion of patients continue to experience uncontrolled symptoms due to persistent airway inflammation and disease heterogeneity.
详细描述
A significant subset of asthma patients exhibits a type 2 inflammatory phenotype characterized by eosinophilic airway inflammation and IgE-mediated immune responses. This phenotype is driven by Th2 cytokines, including IL-4, IL-5, and IL-13, which promote eosinophil recruitment, activation, and survival within the airways. Activated eosinophils release cytotoxic granule proteins such as eosinophil cationic protein (ECP), which contributes to epithelial injury and reflects disease activity. In addition, sputum eosinophil counts are widely validated biomarkers of airway inflammation and are strongly associated with asthma severity and exacerbation risk. Allergen immunotherapy (AIT) is the only disease-modifying treatment for IgE-mediated allergic diseases and represents a cornerstone in the management of allergic asthma. It induces long-term immune tolerance through modulation of allergen-specific immune responses, including suppression of Th2-driven inflammation and enhancement of regulatory immune pathways. Both subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) have demonstrated clinical efficacy in improving asthma outcomes. Recent advances have further elucidated the immunological mechanisms underlying successful AIT, including immune deviation, induction of regulatory T cells, and increased production of blocking antibodies. In addition, personalized medicine approaches increasingly emphasize the role of biomarkers in predicting and monitoring treatment response. Standardization of outcome measures in allergen immunotherapy studies has been strongly recommended to improve comparability across clinical trials and real-world studies. Moreover, real-world evidence continues to support the effectiveness of AIT, although inter-individual variability in response remains a significant clinical challenge. Despite well-established long-term benefits of AIT, early immunologic changes following initiation of SCIT remain insufficiently characterized. Therefore, this study aimed to evaluate early changes in serum eosinophil cationic protein (ECP) and sputum eosinophils following subcutaneous allergen immunotherapy in patients with allergic asthma and to assess their relationship with clinical outcomes.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years and diagnosed of allergic asthma. Patients were clinical stabile and confirmed diagnosis supported by pulmonary function test.
排除标准
- •parasitic infestations
- •recent acute asthma exacerbation
- •current smoking
- •severe persistent asthma
研究组 & 干预措施
Patients with Allergic asthma indicated for immunotherapy
Patients above 18 years old and diagnosed with allergic asthma that was partially controlled under standard medical therapy. Patients were selected based on clinical stability and confirmed diagnosis supported by pulmonary function testing.
干预措施: Allergen Immunotherapy Extract (Drug)
结局指标
主要结局
Clinical response
时间窗: 6 months
The change in total asthma symptom score (TASS) from 0-3 " 0 means no symptoms \& 1 mild \& 2 moderate \& 3 sever"following subcutaneous allergen immunotherapy (SCIT) from baseline to 6 months.
次要结局
未报告次要终点
研究者
Mohamed Abd Elmoniem Mohamed
Lecturer faculty of medicine
Mansoura University Hospital
