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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04895124
Other study ID # 19-12 Ribolution III
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date March 30, 2023

Study information

Verified date August 2023
Source Fraunhofer-Institute of Toxicology and Experimental Medicine
Contact n/a
Is FDA regulated No
Health authority
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. Of this cohort, 116 subjects were re-invited for the first follow-up study Ribolution II (NTC02522026) after 3 years (+/- 6 months) and data on the clinical course and treatment changes was obtained. This second follow-up study will 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 63
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: 1. Participation in the study "11-03 Ribolution". 2. Able and willing to give written informed consent. 3. Females will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Exclusion Criteria: 1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study. 2. Past or present disease developed after the participation in "11-03 Ribolution" or "15-01 Ribolution II", which might interfere with study procedures. 3. Participation in another clinical trial 30 days prior to enrollment. 4. Current drug or alcohol abuse. 5. Risk of non-compliance with study procedures. 6. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study. 7. History of an acute infection four weeks prior to the study procedures, including - but not limited to - moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalization). All courses of oral corticosteroids and antibiotics must be completed at least four weeks prior to all study procedures (with the exception of the informed consent). In case of significant acute infections or moderate or severe exacerbation, the study participation can be split in two separate visits (1. Informed consent visit, 2. Study procedures visit, when subject is fully resolved, at least four weeks after the end of infection/ exacerbation). 8. If performed according to SOP FHI-1-18, positive SARS-CoV-2 rapid antigen test on Day 1. Subjects may be re-screened when confirmatory nucleic acid amplification test was negative or when officially ordered quarantine has ended. 9. Being a vulnerable subject (dependent, in detention or without mental capacity).

Study Design


Related Conditions & MeSH terms


Locations

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

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 Collecting longitudinal patient information by performing a second follow-up visit. Medical history, physical examination, comprehensive lung function and laboratory assessments will be taken and linked respectively with former study data to collate individual clinical courses. 9 years ± 12 months after completion of the study "11-03 Ribolution"
Primary Analysis of exhaled particles Determining airway dimensions by means of time-resolved single breath analysis and collection of exhaled particles for bioanalysis. 9 years ± 12 months after completion of the study "11-03 Ribolution"
Primary Determining predictive power of non-coding RNA patterns Analysis of non-coding RNA from sputum and blood 9 years ± 12 months after completion of the study "11-03 Ribolution"
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