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Completed

NCT Number: NCT02522026

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Fraunhofer-Institute for Toxicology and Experimental Medicine

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Lung volumes by pulmonary function testing

    Time frame: after 3 years ± 6 months

    forced expiratory volume in 1 second

Sponsors and collaborators

Lead sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Other

Registry information

Official study 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

Acronym: Ribo2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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