Exploring Novel Biomarkers for Emphysema Detection

ConditionsCopdEmphysema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University

About this trial

The goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:

• Can a machine-learning based algorithm be developed that can classify the extent of emphysema on chest CT scan from patients with COPD, based on voice and/or capnometry.

Participants will:

* perform different voice-related tasks * perform capnometry twice (before/after exercise) * perform a light exercise task between tasks ( 5-sit-to-stand test) * undergo one venipuncture

Eligibility criteria

Qualifiers

Adults aged over 18 years

current respiratory smptoms (any dyspnea, cough or sputum)

spirometry confirmed diagnosis of a non-fully reversible airflow obstruction, defined as a post bronchodilator Forced Expiratory Volume at one second/Forced Vital Capacity (FEV1/FVC ratio) < 0.7 and/or emphysemateus abnormalities on CT imaging.

presence of risk factors or causes associated with COPD

Disqualifiers

acute exacerbation of COPD within 8 weeks of start of the study

comorbidities affecting speech or breathing coordination (neuromuscular disease, CVA< BMI > 40)

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

Trial design

Treatments tested in this trial

  • voice sampling
  • capnometry

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Maastricht University

Lead sponsor

Roche Pharma AG

Collaborator