Change in Airway Peripheral Tone in COPD

• Conditions: COPD; COPD, Early-Onset

• Registration Number: NCT04166812
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2019-11-19
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
spirometry (change in FEV1)	24 months	change in parameters of central obstruction (forced expiratory volume in one second, FEV1)
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)

Trial Locations

Locations (2)

Pulmonary Research Institute at LungClinic Großhansdorf; 🇩🇪 Großhansdorf, Germany

Thoraxklinik at Heidelberg University; 🇩🇪 Heidelberg, Germany