Evaluation of Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts as an Adjuvant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Quality of Life
研究概览
简要总结
The purpose of this study is to determine the changes of quality of life of patients with allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte Extracts (DLE). All patients will receive DLE in combination with current guide lines-suggested standard medication.
详细描述
DLE are heterogenous mixtures of peptides under 10 kilo Daltons (kDa) obtained after disruption of peripheral blood leukocytes from healthy human donors. DLE have been reported to improve clinical response in allergies, such as asthma and atopic dermatitis.
The therapeutic effect of DLE is related to an immune modulatory effect that changes innate signaling pathways, such as Toll Like Receptors, and Nuclear Factor -kappa B; production of cytokines might also be modified with the use of DLE, including Tumor Necrosis Factor a, Interleukin (IL)-6, and induction of Interferon-g secretion, driving immune response to a T-helper Th1 immune-regulatory response, and thus helping to reduce allergy symptoms.
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
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of symptomatic seasonal or perennial allergic rhinitis
- •Active rhinoconjunctivitis
- •Six week standard treatment before inclusion
- •Confirmation of an Immunoglobulin E-mediated response through previous positive skin or in vitro allergen testing
排除标准
- •Other immunological immune-mediated diseases such as autoimmune diseases and cancer.
- •Unstable chronic disease, such as diabetes, cardiac diseases, chronic kidney failure, chronic hepatic disease.
结局指标
主要结局
Quality of Life
时间窗: 11 weeks
Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico
次要结局
未报告次要终点
研究者
Maria C Jimenez Martinez
MD PhD
National Polytechnic Institute, Mexico