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Ribo2: Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers

Sponsor
Fraunhofer-Institute of Toxicology and Experimental Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02522026
Collaborator
(none)
116
Enrollment
1
Location
19
Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    116 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Aug 1, 2015
    Actual Primary Completion Date :
    Mar 1, 2017
    Actual Study Completion Date :
    Mar 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy volunteers
    Healthy smokers
    COPD GOLD1
    COPD GOLD2
    COPD GOLD3/4

    Outcome Measures

    Primary Outcome Measures

    1. Lung volumes by pulmonary function testing [after 3 years ± 6 months]

      forced expiratory volume in 1 second

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fraunhofer-Institute for Toxicology and Experimental Medicine Hannover Germany 30625

    Sponsors and Collaborators

    • Fraunhofer-Institute of Toxicology and Experimental Medicine

    Investigators

    • Principal Investigator: Jens M Hohlfeld, Prof, Fraunhofer Institute for Toxicology and Experimental Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Jens Hohlfeld, Division Director Airway Research, Fraunhofer-Institute of Toxicology and Experimental Medicine
    ClinicalTrials.gov Identifier:
    NCT02522026
    Other Study ID Numbers:
    • 15-01 RIBO II
    First Posted:
    Aug 13, 2015
    Last Update Posted:
    May 30, 2018
    Last Verified:
    May 1, 2018
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of May 30, 2018