---
title: Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers
nct_id: NCT02522026
overall_status: COMPLETED
sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
study_type: OBSERVATIONAL
primary_condition: Chronic Obstructive Pulmonary Disease
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02522026.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02522026"
ct_last_update_post_date: 2025-02-25
last_seen_at: "2026-05-12T07:32:49.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers

**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

**NCT ID:** [NCT02522026](https://clinicaltrials.gov/study/NCT02522026)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 116
- **Lead Sponsor:** Fraunhofer-Institute of Toxicology and Experimental Medicine
- **Conditions:** Chronic Obstructive Pulmonary Disease
- **Start Date:** 2015-08
- **Completion Date:** 2017-03
- **CT.gov Last Update:** 2025-02-25

## 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.

## Eligibility

- **Sex:** 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)
```

## Arms

- **Healthy volunteers**
- **Healthy smokers**
- **COPD GOLD1**
- **COPD GOLD2**
- **COPD GOLD3/4**

## Primary Outcomes

- **Lung volumes by pulmonary function testing** _(time frame: after 3 years ± 6 months)_ — forced expiratory volume in 1 second

## Locations (1)

- Fraunhofer-Institute for Toxicology and Experimental Medicine, Hanover, Germany

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fraunhofer-institute for toxicology and experimental medicine|hanover||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02522026.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02522026*  
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