COPD, COPD, Early-Onset
Conditions
Keywords
small airway disease, peripheral airway tone
Brief summary
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.
Interventions
DIAGNOSTIC_TESTfractional exhaled nitric oxide
assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide
DIAGNOSTIC_TESTbody plethysmography
assessment of lung function using body plethysmography
DIAGNOSTIC_TESToscillometry
assessment of peripheral airway resistance using oscillometry
DIAGNOSTIC_TESTmultiple breath washout testing
assessment of ventilation heterogeneity using multiple breath washout testing
DIAGNOSTIC_TESTspirometry
assessment of lung function using spirometry
DIAGNOSTIC_TESTtransfer factor
assessment of gas transfer using single breath transfer factor for carbon monoxide
DIAGNOSTIC_TESThealth status
assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire \[SGRQ\], COPD Assessment Test \[CAT\])
DIAGNOSTIC_TESTcomputed tomography
assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)
DIAGNOSTIC_TESTinduced sputum
various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)
Sponsors
PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator)
Chiesi GmbH, Hamburg, Germany (Funding)
Heidelberg University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients at risk for COPD inclusion criteria: * smoking history (at least 10 pack years) * absence of airway obstruction (FEV1/FVC ≥ 70% after salbutamol 400µg) * high symptom score (CAT ≥ 10) or long acting bronchodilator therapy * age \> 35 years
Exclusion criteria
* respiratory infection within 4 weeks prior to inclusion * other symptomatic pulmonary disease, except bronchial asthma patients with early COPD inclusion criteria: * smoking history (at least 10 pack years) * mild COPD (FEV1/FVC \< 70% and FEV1 ≥ 70% after salbutamol 400µg) * age \> 35 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oscillometry (change in R5-20) | 24 months | change in frequency dependence of resistance (R5-20) |
| multiple breath washout testing (change in LCI) | 24 months | change in global ventilation heterogeneity (lung clearance index, LCI) |
| multiple breath washout testing (change in Scond) | 24 months | change in conductive ventilation heterogeneity (Scond) |
| multiple breath washout testing (change in Sacin) | 24 months | change in acinar ventilation heterogeneity (Sacin) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| spirometry (change in FEV1) | 24 months | change in parameters of central obstruction (forced expiratory volume in one second, FEV1) |
| body plethysmography (change in RV/TLC) | 24 months | change in parameters of hyperinflation (residual volume / total lung capacity RV/TLC) |
| body plethysmography (change in sRaw) | 24 months | change in specific airway resistance (sRaw) |
| health Status (change in SGRQ-c) | 24 months | change in quality of life (SGRQ-c) |
| health Status (change in CAT) | 24 months | change in symptom score (CAT) |
Countries
Germany
Outcome results
None listed