NCT04166812

Change in Airway Peripheral Tone in COPD

Role of Small Airway Dysfunction for Disease Progression in Early COPD - an Observational Two-year Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2019-11-19
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2019-11-18
• Last updated: 2021-07-14

Locations

2 sites across 1 country: Germany