NCT02228018

The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers

The Comparison of Electronic Auscultation Coupled With Computer Aided Lung Sound Analysis (CALSA) and Functional Respiratory Imaging (FRI) and Repeatability of FRI Biomarkers in Healthy Subjects and Asthma Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: FLUIDDA nv · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.

Detailed description

his is a study with no investigational product. CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients. Electronic auscultation of respiratory sounds will be performed, lung function tests (at maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be taken. The scans will be taken at two different breathing levels, more specifically at total lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be taken. The objective of this study is to compare CALSA with FRI and to assess the repeatability of FRI biomarkers

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	CT-scan	CT-Scan will be taken at visit 1 on FRC and TLC breathing levels

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-08-28
• Last updated: 2016-02-03

Locations

1 site across 1 country: Belgium