Change in Airway Peripheral Tone in COPD

Heidelberg University150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

COPD COPD, Early-Onset

Interventions

oscillometryDIAGNOSTIC_TEST

assessment of peripheral airway resistance using oscillometry

assessment of ventilation heterogeneity using multiple breath washout testing

spirometryDIAGNOSTIC_TEST

assessment of lung function using spirometry

body plethysmographyDIAGNOSTIC_TEST

assessment of lung function using body plethysmography

fractional exhaled nitric oxideDIAGNOSTIC_TEST

assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide

transfer factorDIAGNOSTIC_TEST

assessment of gas transfer using single breath transfer factor for carbon monoxide

health statusDIAGNOSTIC_TEST

assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire \[SGRQ\], COPD Assessment Test \[CAT\])

computed tomographyDIAGNOSTIC_TEST

assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)

induced sputumDIAGNOSTIC_TEST

various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (2)

Pulmonary Research Institute at LungClinic Großhansdorf

Großhansdorf, Germany

Thoraxklinik at Heidelberg University

Heidelberg, Germany

Outcomes

Primary Outcomes

oscillometry (change in R5-20)

change in frequency dependence of resistance (R5-20)

Time frame: 24 months

multiple breath washout testing (change in LCI)

change in global ventilation heterogeneity (lung clearance index, LCI)

Time frame: 24 months

multiple breath washout testing (change in Scond)

change in conductive ventilation heterogeneity (Scond)

Time frame: 24 months

multiple breath washout testing (change in Sacin)

change in acinar ventilation heterogeneity (Sacin)

Time frame: 24 months

Secondary Outcomes

spirometry (change in FEV1)

change in parameters of central obstruction (forced expiratory volume in one second, FEV1)

Time frame: 24 months

body plethysmography (change in RV/TLC)

change in parameters of hyperinflation (residual volume / total lung capacity RV/TLC)

Time frame: 24 months

body plethysmography (change in sRaw)

change in specific airway resistance (sRaw)

Time frame: 24 months

health Status (change in SGRQ-c)

change in quality of life (SGRQ-c)

Time frame: 24 months

health Status (change in CAT)

change in symptom score (CAT)

Time frame: 24 months

Data from ClinicalTrials.gov

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