Chronic Obstructive Pulmonary DiseaseRibo2NCT02522026
Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers
An observational study of Chronic Obstructive Pulmonary Disease, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 116 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Participants in Study "11-03 Ribolution"
- Able and willing to give written informed consent
- Not pregnant, as confirmed by pregnancy test
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer-Institute for Toxicology and Experimental Medicine
Hanover, 30625
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described | |
| Healthy smokers | Not described | |
| COPD GOLD1 | Not described | |
| COPD GOLD2 | Not described | |
| COPD GOLD3/4 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung volumes by pulmonary function testing
forced expiratory volume in 1 second
Measured: after 3 years ± 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Jens Hohlfeld, MD, Fraunhofer-Institute of Toxicology and Experimental Medicine
- Investigators
- Jens M Hohlfeld, Prof, Principal investigator, Fraunhofer Institute for Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522026
- Sponsor's protocol ID
- 15-01 RIBO II
- Acronym
- Ribo2
- Status last verified
- Feb 2025
- First submitted
- 7 Aug 2015
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02522026
- Acronym / sponsor ID
- Ribo2 / 15-01 RIBO II
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| Healthy smokers | – | – |
| COPD GOLD1 | – | – |
| COPD GOLD2 | – | – |
| COPD GOLD3/4 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Participants in Study "11-03 Ribolution"
- Able and willing to give written informed consent
- Not pregnant, as confirmed by pregnancy test
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung volumes by pulmonary function testing
Time frame: after 3 years ± 6 months
forced expiratory volume in 1 second
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens M Hohlfeld, Prof principal investigator
Fraunhofer Institute for Toxicology and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung volumes by pulmonary function testing (time frame: after 3 years ± 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.