Second Follow-up Study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers (Ribo III)

Second 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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects with chronic obstructive pulmonary disease (COPD) GOLD stage I to IV, healthy smokers and healthy non-smokers

Description

Inclusion Criteria:

1. Participation in the study "11-03 Ribolution".
2. Able and willing to give written informed consent.
3. Females will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing.

Exclusion Criteria:

1. 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.
2. Past or present disease developed after the participation in "11-03 Ribolution" or "15-01 Ribolution II", which might interfere with study procedures.
3. Participation in another clinical trial 30 days prior to enrollment.
4. Current drug or alcohol abuse.
5. Risk of non-compliance with study procedures.
6. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
7. 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).
8. 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.
9. Being a vulnerable subject (dependent, in detention or without mental capacity).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Healthy volunteers
Healthy smokers
COPD GOLD I
COPD GOLD II
COPD GOLD III/IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collecting longitudinal patient information by performing a second follow-up visit.	Medical history, physical examination, comprehensive lung function and laboratory assessments will be taken and linked respectively with former study data to collate individual clinical courses.	9 years ± 12 months after completion of the study "11-03 Ribolution"
Analysis of exhaled particles	Determining airway dimensions by means of time-resolved single breath analysis and collection of exhaled particles for bioanalysis.	9 years ± 12 months after completion of the study "11-03 Ribolution"
Determining predictive power of non-coding RNA patterns	Analysis of non-coding RNA from sputum and blood	9 years ± 12 months after completion of the study "11-03 Ribolution"

Collaborators and Investigators

• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 19-12 Ribolution III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No