Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers (Ribo2)

February 24, 2025 updated by: Prof. Dr. Jens Hohlfeld, MD, Fraunhofer-Institute of Toxicology and Experimental Medicine

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Fraunhofer-Institute for Toxicology and Experimental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy volunteers
Healthy smokers
COPD GOLD1
COPD GOLD2
COPD GOLD3/4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung volumes by pulmonary function testing
Time Frame: after 3 years ± 6 months
forced expiratory volume in 1 second
after 3 years ± 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Investigators

  • Principal Investigator: Jens M Hohlfeld, Prof, Fraunhofer Institute for Toxicology and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimated)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-01 RIBO II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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