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

NCT ID: NCT02228018

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CALSA and FRI repeatability

CT-Scan No medication used

Group Type: EXPERIMENTAL

CT-scan

Intervention Type: DEVICE

CT-Scan will be taken at visit 1 on FRC and TLC breathing levels

Interventions

CT-scan

CT-Scan will be taken at visit 1 on FRC and TLC breathing levels

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FLUIDDA nv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilfried De Backer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

FLUI-2014-118

Identifier Type: -

Identifier Source: org_study_id