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临床试验/NCT00250263
NCT00250263已完成4 期

A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy

Bayside Health1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy.

研究概览

简要总结

Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including sublingual (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The first year will be followed by an optional open label extension period. Immunoregulatory cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy. SLIT has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • allergic rhinitis and/or
  • mild stable asthma
  • house dust mite allergic
  • positive HDM-specific IgE as determined by skin prick test (wheal diameter >6 mm to D. pteronyssinus) or CAP-Pharmacia score > 2

排除标准

  • Immunodeficiency diseases
  • Severe or uncontrolled asthma
  • Previous immunotherapy with House dust mite (HDM) extract within the last five years or ongoing immunotherapy with HDM or other allergens
  • Continuous oral corticosteroids
  • Subjects on treatment with beta-blockers
  • Pregnant women

研究组 & 干预措施

1

Placebo Comparator

Matching placebo- control arm (first year)

干预措施: Placebo (Drug)

2

Active Comparator

Drug Staloral (active group)

干预措施: (agent for immunotherapy) Staloral (Drug)

结局指标

主要结局

Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy.

时间窗: 12 and 24 months

-Expression of "immunoregulatory" cytokines by CD4+ T

时间窗: 12 and 24 months

cells

时间窗: 12 and 24 months

- Helper, regulatory and memory T cell subsets

时间窗: 12 and 24 months

(a) Helper T cells

时间窗: 12 and 24 months

(b) Regulatory T cells

时间窗: 12 and 24 months

b1- Regulatory T cell phenotype

时间窗: 12 and 24 months

b2- Regulatory T cell function

时间窗: 12 and 24 months

次要结局

  • Symptom diary, medication use, visual analogue score, disease-specific rhinoconjunctivitis Quality of Life Questionnaire(12 and 24 months)

研究者

发起方
Bayside Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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