Change in Airway Peripheral Tone in COPD
NCT04166812 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2021-07-14
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.
Conditions
- COPD
- COPD, Early-Onset
Interventions
- 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)
Sponsors & Collaborators
-
PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator)
collaborator UNKNOWN -
Chiesi GmbH, Hamburg, Germany (Funding)
collaborator UNKNOWN -
Heidelberg University
lead OTHER
Principal Investigators
-
Henrik Watz, MD · Pulmonary Research Institute at LungClinic Großhansdorf
-
Frederik Trinkmann, MD · Thoraxklinik at Heidelberg University
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-19
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
Countries
- Germany
Study Locations
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