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临床试验/NCT02090374
NCT02090374已完成不适用

Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen: Monophosphoryl lipidA, Poly-inosine-cytosine, Poly-inosine-cytosine Stabilised With Poly-L-lysine and Carboxymethylcellulose, Resiquimod, Tuberculin and Timothy Grass Pollen

Imperial College London2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
IFN-y Protein Response in Mucosal Lining Fluid

研究概览

简要总结

The investigators propose the development of a range of nasal spray challenge models to study the way the nose can respond to different types of nasal challenge that elicit different forms of inflammation.

The investigators will carry out nasal challenge with bacterial and viral components and allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli of the immune system, causing various types of inflammation. Samples will be taken by blotting the nostril surface and by scraping off tiny surface samples.

The nose will be sprayed with a substance that is a single part of a bacteria or virus, or with an allergen. The material delivered by nasal spray is of high purity and is sterile, containing no live bacteria or viruses. The nasal spray substance contains molecular patterns that are recognised as foreign by the immune system, and at the right dose should stimulate the immune system, causing mild nasal inflammation. The study employs noninvasive methods of sampling using absorptive strips. These strips look and feel like tissue paper, and are applied to each nostril for a period of 1 min. A few pinhead-sized tissue samples are taken from inside the nose, using a small disposable sterile plastic probe that has a tiny scoop on its end. In the nasal lining fluid and tissue samples, measurement will taken of a range of molecules and cells that protect against infections and help the immune response.

By spraying the nose with a challenge agent in this manner, the nasal immune response can be assessed, which can help us better understand how the human immune system cells and molecules respond to bacteria and viruses. In the future, this may allow the testing of new drugs and vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge.

详细描述

STUDY DESIGN AND METHODOLOGY

The study involves 3 parts with different nasal spray challenges being administered to subjects:

  1. Bacterial or viral components, comprising one of the following in a particular patient;

  2. MPLA (monophosphoryl lipid A) resembles bacterial lipopolysaccharide

  3. PolyIC (polyinosinic and cytidylic acids): viral component

  4. PolyICLC (polyIC stabilised with polyLlysine): viral component

  5. Resiquimod: viral mimic

  6. Tuberculin: partially purified protein derivative (PPD) from Mycobacterium bovis, the bacteria that causes TB.

  7. Allergen: The nasal spray challenge agent is Timothy grass pollen.

RECRUITMENT

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

IFN-y Protein Response in Mucosal Lining Fluid

时间窗: 0, 1, 2, 3, 4, 6, 8 hours post-dose

The primary outcome measure is IFN-y in nasal mucosal lining fluid after nasal challenge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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