Second Follow-up Study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-cod… (NCT04895124) | Clinical Trial Compass
CompletedNot Applicable
Second Follow-up Study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers
Germany63 participantsStarted 2021-05-25
Plain-language 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.
Of this cohort, 116 subjects were re-invited for the first follow-up study Ribolution II (NTC02522026) after 3 years (+/- 6 months) and data on the clinical course and treatment changes was obtained.
This second follow-up study will 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participation in the study "11-03 Ribolution".
. Able and willing to give written informed consent.
. Females will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing.
Exclusion criteria
. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
. Past or present disease developed after the participation in "11-03 Ribolution" or "15-01 Ribolution II", which might interfere with study procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collecting longitudinal patient information by performing a second follow-up visit.
Timeframe: 9 years ± 12 months after completion of the study "11-03 Ribolution"
2
Analysis of exhaled particles
Timeframe: 9 years ± 12 months after completion of the study "11-03 Ribolution"
3
Determining predictive power of non-coding RNA patterns
Timeframe: 9 years ± 12 months after completion of the study "11-03 Ribolution"
Trial details
NCT IDNCT04895124
SponsorFraunhofer-Institute of Toxicology and Experimental Medicine
. Participation in another clinical trial 30 days prior to enrollment.
. Current drug or alcohol abuse.
. Risk of non-compliance with study procedures.
. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
. History of an acute infection four weeks prior to the study procedures, including - but not limited to - moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalization). All courses of oral corticosteroids and antibiotics must be completed at least four weeks prior to all study procedures (with the exception of the informed consent). In case of significant acute infections or moderate or severe exacerbation, the study participation can be split in two separate visits (1. Informed consent visit, 2. Study procedures visit, when subject is fully resolved, at least four weeks after the end of infection/ exacerbation).
. If performed according to SOP FHI-1-18, positive SARS-CoV-2 rapid antigen test on Day 1. Subjects may be re-screened when confirmatory nucleic acid amplification test was negative or when officially ordered quarantine has ended.