Change in Airway Peripheral Tone in COPD

NCT04166812 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-07-14

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04166812 on ClinicalTrials.gov