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临床试验/NCT00290381
NCT00290381已完成1 期

The Effects of OC000459 on Nasal Th2 Cytokine Release, Eosinophil Responses, and Nasal Symptoms After Nasal Allergen Challenge (NAC) With Timothy Grass Pollen in Subjects With Allergic Rhinitis Out of Season

Trevor Hansel2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年2月13日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13

研究概览

简要总结

This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study.

The study will be a randomised, double blind, placebo controlled, crossover evaluation of the effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects with a known history of allergic rhinitis and screening positive to allergen will be included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety parameters will be monitored throughout.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.

排除标准

  • Medical conditions likely to affect the outcome of the study.
  • 2 History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
  • Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.

结局指标

主要结局

The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13

时间窗: 1 to 9 hours after nasal allergen challenge

次要结局

未报告次要终点

研究者

发起方
Trevor Hansel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Trevor Hansel

Imperial College

Imperial College London

研究点 (2)

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