Exploring Novel Biomarkers for Emphysema Detection: the ENBED study

Recruiting

• Conditions: COPD; emphysema; 10006436

• Registration Number: NL-OMON53600
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 185

Inclusion Criteria

- Adults aged over 18 years
- current respiratory symptoms (any dyspnea, cough, or sputum)
- Spirometry-confirmed diagnosis of a non-fully reversible airflow obstruction
(defined as postbronchodilator FEV1/FVC < 0.7)
- chest CT scan performed in the past 12 months before the start of the study
- able to understand, read and write Dutch language.

Exclusion Criteria

- acute exacerbation of COPD within 8 weeks of start of the study
- comorbidities affecting speech or breathing coordination (neuromuscular
disease, CVA)
- comorbidities affecting speech characteristics of dyspnea (severe heart
failure, interstitial lung disease)
- comorbidities affecting respiratory system including but not exclusive to
asthma or cystic fibrosis
- Comorbidities that significantly interfere with interpretation of speech
(audio signals), such as Parkinson*s disease, bulbar palsy, or vocal cord
paralysis.
- inability to carry out a capnography recording.
- Investigator*s uncertainty about the willingness or ability of the patients
to comply with the protocol requirements.
- Participation in another study involving investigational products.
Participation in observational studies is allowed.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate whether voice or capnometry, alone or in combination with other<br /><br>(non-invasive) biomarkers, can be used to classify emphysema predominant COPD<br /><br>phenotype (>=25% emphysematous lung tissue). Study endpoints are: Emphysema<br /><br>quantification (25% of voxels below *950HU on a HRCT scan), Voice<br /><br>characteristics (see table 1), Capnometry (end-tidal CO2, Slp2 and Slp3) and<br /><br>Emphysema Severity Index (FEF25, FEF25, FEF75) </p><br>