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

FLUIDDA

Status

Withdrawn

Conditions

Asthma

Treatments

Device: CT-scan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02228018

FLUI-2014-118

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18 to 120 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female patient / volunteer ≥ 18 years old
Written informed consent obtained
The subject belongs to 1 of the following groups in the opinion of the investigator:

Group 1: healthy volunteer Group 2: patient with asthma

Only if patient/ volunteer is a female of childbearing potential: Confirmation that a contraception method was used at least 14 days before visit 1

Exclusion criteria

Pregnant or lactating female
Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.

Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.