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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02522026

Acronym

Ribo2

Enrollment

116

Registered

2015-08-13

Start date

2015-08-31

Completion date

2017-03-31

Last updated

2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

Germany

Outcome results