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临床试验/NCT00470457
NCT00470457已完成2 期

A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration

University of Zurich1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2001年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
156
试验地点
1
主要终点
Safety efficacy and toxicity

研究概览

简要总结

Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years.

  • Trial with immunodulatory product / biological

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • History of allergic rhino-conjunctivitis in spring and summer
  • Age 18 years to 65 years
  • Positive skin prick test to grass pollen

排除标准

  • Blood donation within previous 30 days
  • Surgery within the previous 30 days
  • Use of investigational drugs within previous 90 days
  • Pregnancy or nursing
  • Mastocytosis
  • Significant cardiovascular disease
  • Hypertension
  • Active infectious disease
  • Significant hepatic disease
  • Significant renal disease
  • Significant hematological disorder
  • Significant pulmonary disease
  • Moderate or severe asthma
  • Autoimmune disease
  • History of malignancy.
  • Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.

结局指标

主要结局

Safety efficacy and toxicity

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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