CAPTO-COPD: Change in Airway Peripheral Tone in COPD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients with early COPD diagnosis according to current GOLD recommendations |
Diagnostic Test: oscillometry
assessment of peripheral airway resistance using oscillometry
Diagnostic Test: multiple breath washout testing
assessment of ventilation heterogeneity using multiple breath washout testing
Diagnostic Test: spirometry
assessment of lung function using spirometry
Diagnostic Test: body plethysmography
assessment of lung function using body plethysmography
Diagnostic Test: fractional exhaled nitric oxide
assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide
Diagnostic Test: transfer factor
assessment of gas transfer using single breath transfer factor for carbon monoxide
Diagnostic Test: health status
assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT])
Diagnostic Test: computed tomography
assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)
Diagnostic Test: induced sputum
various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)
|
| patients at risk for COPD no current diagnosis according to GOLD recommendations, but at risk for COPD |
Diagnostic Test: oscillometry
assessment of peripheral airway resistance using oscillometry
Diagnostic Test: multiple breath washout testing
assessment of ventilation heterogeneity using multiple breath washout testing
Diagnostic Test: spirometry
assessment of lung function using spirometry
Diagnostic Test: body plethysmography
assessment of lung function using body plethysmography
Diagnostic Test: fractional exhaled nitric oxide
assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide
Diagnostic Test: transfer factor
assessment of gas transfer using single breath transfer factor for carbon monoxide
Diagnostic Test: health status
assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT])
Diagnostic Test: computed tomography
assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)
Diagnostic Test: induced sputum
various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
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
exclusion criteria:
-
respiratory infection within 4 weeks prior to inclusion
-
other pulmonary disease, except bronchial asthma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pulmonary Research Institute at LungClinic Großhansdorf | Großhansdorf | Germany | 22927 | |
| 2 | Thoraxklinik at Heidelberg University | Heidelberg | Germany | 69126 |
Sponsors and Collaborators
- Heidelberg University
- PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator)
- Chiesi GmbH, Hamburg, Germany (Funding)
Investigators
- Principal Investigator: Henrik Watz, MD, Pulmonary Research Institute at LungClinic Großhansdorf
- Principal Investigator: Frederik Trinkmann, MD, Thoraxklinik at Heidelberg University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAPTO-COPD