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临床试验/NCT01523158
NCT01523158终止不适用

An Open Study to Investigate the Effects of Injection Immunotherapy on Allergen-specific T and B Cell Responses in Adult Patients With Seasonal Allergic Rhinitis.

Royal Sussex County Hospital2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2
试验地点
2
主要终点
What are the changes in T cells associated with immunotherapy?

研究概览

简要总结

Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The majority of affected individuals manage well with medication from the Pharmacy or from their general practitioner (GP), but for some severely affected people it severely impacts on quality of life. Less than 40% of those affected in UK general practice feel that these medications achieve good symptomatic control.

Specific immunotherapy or desensitisation is the practice of administering small amounts of allergen to allergic patients in increasing doses. This treatment is highly effective in these patients and furthermore is truly disease-modifying, with benefits persisting long-term, even when the treatment has been completed. Desensitisation is a routine treatment in the UK, Europe and North America. The exact immune mechanisms that underlie this symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor Kern have recently developed new methods for the investigation of immune responses to allergens. These methods require relatively small blood samples and may provide useful information about how immunotherapy exerts its effects. In addition to improving the investigators basic understanding of this treatment, such knowledge may drive improvements in the treatment and could be useful for monitoring patients for response. The investigators study proposes to investigate changes in the immune responses to pollen allergens during immunotherapy. Blood will be taken just prior to the first immunotherapy injection and again just prior to the final injection. In this way the investigators will be able to compare the immune responses to pollen allergen before and after treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Male or female
  • Age 18 with no upper age limit
  • History of seasonal rhino-conjunctivitis in the appropriate season, not controlled by optimised standard medical therapy
  • Positive skin prick test to grass pollen or tree pollen

排除标准

  • Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
  • Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
  • Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
  • Local or systemic use of beta blockers
  • Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
  • Malignant disease within the past five years (Patients with previous malignant disease that is considered cured may be included subject to the consent of their oncologist)
  • Inability to attend regularly for injections and follow-up visits
  • Severe atopic dermatitis
  • Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
  • Breast-feeding
  • Evidence of current drug or alcohol misuse
  • Hypersensitivity to any of the SIT (immunotherapy product) excipients
  • Active tuberculosis
  • Severe mental disorders
  • Multiple sclerosis

结局指标

主要结局

What are the changes in T cells associated with immunotherapy?

时间窗: 6 months

How does the T cell response change after immunotherapy

次要结局

未报告次要终点

研究者

发起方
Royal Sussex County Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Gray

Clinical Research Fellow

Royal Sussex County Hospital

研究点 (2)

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