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| Name | Class |
|---|---|
| PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator) | UNKNOWN |
| Chiesi GmbH, Hamburg, Germany (Funding) | UNKNOWN |
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Small airways disease is a pathological feature in mild to moderate COPD, which might be causally involved in disease progression. However, there are only limited studies available that prospectively identified patients at risk for small airway disease. Our intention is to investigate the early phase of the disease. In addition, we thereby want to build up a well-defined study population of patients in an early phase of the disease with a rapid decrease in lung function as measured by oscillometry and multiple breath washout (MBW)-testing. In addition, it is our goal to identify patients in an early stage of disease and patients at risk of fast progression and/or rapid decline in lung function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with early COPD | diagnosis according to current GOLD recommendations |
| |
| patients at risk for COPD | no current diagnosis according to GOLD recommendations, but at risk for COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oscillometry | Diagnostic Test | assessment of peripheral airway resistance using oscillometry |
|
| Measure | Description | Time Frame |
|---|---|---|
| oscillometry (change in R5-20) | change in frequency dependence of resistance (R5-20) | 24 months |
| multiple breath washout testing (change in LCI) | change in global ventilation heterogeneity (lung clearance index, LCI) | 24 months |
| multiple breath washout testing (change in Scond) | change in conductive ventilation heterogeneity (Scond) | 24 months |
| multiple breath washout testing (change in Sacin) | change in acinar ventilation heterogeneity (Sacin) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| spirometry (change in FEV1) | change in parameters of central obstruction (forced expiratory volume in one second, FEV1) | 24 months |
| body plethysmography (change in RV/TLC) | change in parameters of hyperinflation (residual volume / total lung capacity RV/TLC) |
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patients at risk for COPD
inclusion criteria:
exclusion criteria:
patients with early COPD
inclusion criteria:
exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Watz, MD | Pulmonary Research Institute at LungClinic Großhansdorf | Principal Investigator |
| Frederik Trinkmann, MD | Thoraxklinik at Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Research Institute at LungClinic Großhansdorf | Großhansdorf | 22927 | Germany | |||
| Thoraxklinik at Heidelberg University |
data protection rules do not allow to share individual participant data
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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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| ID | Term |
|---|---|
| D013147 | Spirometry |
| D010993 | Plethysmography, Whole Body |
| D000089142 | Fractional Exhaled Nitric Oxide Testing |
| D005144 | F Factor |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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venous blood samples
| multiple breath washout testing | Diagnostic Test | assessment of ventilation heterogeneity using multiple breath washout testing |
|
| spirometry | Diagnostic Test | assessment of lung function using spirometry |
|
| body plethysmography | Diagnostic Test | assessment of lung function using body plethysmography |
|
| fractional exhaled nitric oxide | Diagnostic Test | assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide |
|
| transfer factor | Diagnostic Test | assessment of gas transfer using single breath transfer factor for carbon monoxide |
|
| health status | Diagnostic Test | assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT]) |
|
| computed tomography | Diagnostic Test | assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site) |
|
| induced sputum | Diagnostic Test | various biomarkers (subgroup of approximately 75 patients, Großhansdorf site) |
|
| 24 months |
| body plethysmography (change in sRaw) | change in specific airway resistance (sRaw) | 24 months |
| health Status (change in SGRQ-c) | change in quality of life (SGRQ-c) | 24 months |
| health Status (change in CAT) | change in symptom score (CAT) | 24 months |
| Heidelberg |
| 69126 |
| Germany |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010991 | Plethysmography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D001944 | Breath Tests |
| D010957 | Plasmids |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |