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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | |||
| Healthy smokers | |||
| COPD GOLD I | |||
| COPD GOLD II | |||
| COPD GOLD III/IV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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" |
| 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" |
| 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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Inclusion Criteria:
Exclusion Criteria:
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Subjects with chronic obstructive pulmonary disease (COPD) GOLD stage I to IV, healthy smokers and healthy non-smokers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraunhofer Institute for Toxicology and Experimental Medicine | Hanover | Lower Saxony | 30625 | Germany |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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blood, sputum
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |