Follow-up-study of Participants (COPD Patients and Healthy Control Subjects) From the Cross-sectional Study "11-03 Ribolution" for the Evaluation of Predictive Biomarkers Based on Non-coding RNA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Lung volumes by pulmonary function testing
研究概览
简要总结
Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined regarding different clinical and blood/ sputum derived biomarkers at the investigators' research center. This observation study will follow-up/re-examine all available subjects regarding disease course and treatment changes after 3 years (+/-6 months) for the investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease progression. In addition, biobanking of respective biosamples for potential future COPD biomarker research will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in Study "11-03 Ribolution"
- •Able and willing to give written informed consent
- •Not pregnant, as confirmed by pregnancy test
排除标准
- •Past or present disease occurred since participation in "11-03 Ribolution", which as judged by the investigator, may affect the outcome of the study.
- •Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety
- •Has experienced a significant upper or lower respiratory tract infection incl. moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 4 weeks before study start
- •Clinically significant pathological findings in safety laboratory tests having an impact on study participation.
- •Actual drug or alcohol abuse.
- •Suspected inability to understand and follow protocol requirements, instructions, study-related restrictions, and to understand nature, scope, and possible consequences of the study.
- •Being a vulnerable subject (dependent, in detention, or without mental capacity)
结局指标
主要结局
Lung volumes by pulmonary function testing
时间窗: after 3 years ± 6 months
forced expiratory volume in 1 second
次要结局
未报告次要终点
研究者
Prof. Dr. Jens Hohlfeld, MD
Division Director Airway Research
Fraunhofer-Institute of Toxicology and Experimental Medicine