Change in Airway Peripheral Tone in COPD

• Conditions: COPD; COPD, Early-Onset
• Interventions: Diagnostic Test: oscillometry; Diagnostic Test: multiple breath washout testing; Diagnostic Test: spirometry; Diagnostic Test: body plethysmography; Diagnostic Test: fractional exhaled nitric oxide; Diagnostic Test: transfer factor; Diagnostic Test: health status; Diagnostic Test: computed tomography; Diagnostic Test: induced sputum

• 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

Arm && Interventions

Group	Intervention	Description
patients with early COPD	oscillometry	diagnosis according to current GOLD recommendations
patients with early COPD	health status	diagnosis according to current GOLD recommendations
patients with early COPD	multiple breath washout testing	diagnosis according to current GOLD recommendations
patients with early COPD	transfer factor	diagnosis according to current GOLD recommendations
patients at risk for COPD	computed tomography	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients with early COPD	spirometry	diagnosis according to current GOLD recommendations
patients at risk for COPD	health status	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients with early COPD	body plethysmography	diagnosis according to current GOLD recommendations
patients with early COPD	fractional exhaled nitric oxide	diagnosis according to current GOLD recommendations
patients at risk for COPD	oscillometry	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients at risk for COPD	spirometry	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients with early COPD	computed tomography	diagnosis according to current GOLD recommendations
patients at risk for COPD	body plethysmography	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients at risk for COPD	fractional exhaled nitric oxide	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients at risk for COPD	transfer factor	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients with early COPD	induced sputum	diagnosis according to current GOLD recommendations
patients at risk for COPD	multiple breath washout testing	no current diagnosis according to GOLD recommendations, but at risk for COPD
patients at risk for COPD	induced sputum	no current diagnosis according to GOLD recommendations, but at risk for COPD

Primary Outcome Measures

Name	Time	Method
multiple breath washout testing (change in Sacin)	24 months	change in acinar ventilation heterogeneity (Sacin)
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)

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