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

Chronic Obstructive Pulmonary Disease Clinical Trial

— Ribo2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522026
• Other study ID #: 15-01 RIBO II
• Status: Completed
• Start date: August 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2018
• Source: Fraunhofer-Institute of Toxicology and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	Fraunhofer-Institute for Toxicology and Experimental Medicine	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Fraunhofer-Institute of Toxicology and Experimental Medicine

Country where clinical trial is conducted

Germany, 

Outcome

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