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

NCT ID: NCT02522026

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy volunteers

No interventions assigned to this group

Healthy smokers

No interventions assigned to this group

COPD GOLD1

No interventions assigned to this group

COPD GOLD2

No interventions assigned to this group

COPD GOLD3/4

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fraunhofer-Institute of Toxicology and Experimental Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Jens Hohlfeld, MD

Division Director Airway Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jens M Hohlfeld, Prof

Role: PRINCIPAL_INVESTIGATOR

Fraunhofer Institute for Toxicology and Experimental Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fraunhofer-Institute for Toxicology and Experimental Medicine

Hanover, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-01 RIBO II

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of COPD Subgroups and Biomarkers
NCT01969344 ACTIVE_NOT_RECRUITING