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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02522026
• Lead Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-13
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung volumes by pulmonary function testing	after 3 years ± 6 months	forced expiratory volume in 1 second

Trial Locations

Locations (1)

Fraunhofer-Institute for Toxicology and Experimental Medicine; 🇩🇪 Hannover, Germany