Clinical trial NCT02522026: Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All 150 patients of study "11-03 Ribolution" will be contacted and re-invited for the current follow-up study as completely as possible

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participants in Study "11-03 Ribolution"
* Able and willing to give written informed consent
* Not pregnant, as confirmed by pregnancy test

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Lung volumes by pulmonary function testing
timeFrame: after 3 years ± 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Fraunhofer-Institute for Toxicology and Experimental Medicine
Study officials:
affiliation: Fraunhofer Institute for Toxicology and Experimental Medicine
name: Jens M Hohlfeld, Prof
role: PRINCIPAL_INVESTIGATOR
References: