跳至主要内容
临床试验/NCT02392481
NCT02392481已完成不适用

An Exploratory, Prospective, Non-interventional Study Comparing Biomarker Signatures Between Patients With Asthma and Healthy Volunteers and to Investigate Biomarkers Associated With Known Phenotypes Across Asthma Severities

Boehringer Ingelheim4 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2015年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
4
主要终点
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)

研究概览

简要总结

The main objective of the trial is to explore if any of the biomarkers assessed are sensitively linked to the asthma phenotypes. This would potentially alone or in addition to other clinical or biofluid markers indicate if and how asthma endotypes are linked to phenotype such as eosinophilic, neutrophilic, or paucigranulocytic phenotypes. Further exploratory markers will be analysed for better understanding of physiological levels of proteins and markers playing a role in regard to disease characterization in asthma. As a basis for further development of a biomarker for asthma, The sponsor plans to conduct this exploratory biomarker trial to determine levels and reference ranges of biomarkers potentially associated with asthma phenotypes. The trial aims at generating a panel of serum biomarkers that can be evaluated in subsequent interventional studies. The longitudinal design will be used to ascertain stability and test-retest reliability.

详细描述

Purpose:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)

时间窗: Baseline (Visit 1)

Level of Tumour Necrosis Factor-alpha (TNF-α) \[picograms per milliliter (pg/mL)\] in blood at baseline (Visit 1) is presented.

Level of Interleukin-6 (IL-6) in Blood at Baseline (Visit 1)

时间窗: Baseline (Visit 1)

Level of Interleukin-6 (IL-6) (pg/mL) in blood at baseline (Visit 1) is presented.

次要结局

  • Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)(follow-up visit 28 days after baseline (Visit 2))
  • Level of Interleukin-6 (IL-6) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)(follow-up visit 28 days after baseline (Visit 2))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验