跳至主要内容
临床试验/NCT04104594
NCT04104594终止不适用

Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
expression rate of TNF-alpha in biopsies

研究概览

简要总结

Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

expression rate of TNF-alpha in biopsies

时间窗: 2 months

The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score.

Sniffin Stick test score

时间窗: 2 months

The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score. Sniffin Stick test score : The final score, out of 48, is the sum of the olfactory threshold (out of 16), discrimination (out of 16) and identification (out of 16) scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.

次要结局

  • dosage of cytokines IFN-γ(2 months)
  • dosage of cytokines IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A(2 months)
  • expression rate of TNF-alpha in polyps(2 months)
  • Olfactory Cleft Endoscopic Score(2 months)
  • dosage of cytokines G-CSF(2 months)
  • dosage of cytokines GM-CSF(2 months)
  • dosage of cytokines MCP-1(2 months)
  • dosage of cytokines MIP-1β(2 months)
  • dosage of cytokines MCAF(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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