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
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
- 是
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))
