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

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ClinicalTrials.gov Identifier: NCT02228018
Recruitment Status : Withdrawn (Other strategies followed)
First Posted : August 28, 2014
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

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.

Condition or disease Intervention/treatment Phase
Asthma Device: CT-scan Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : March 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: CALSA and FRI repeatability
CT-Scan No medication used
Device: CT-scan
CT-Scan will be taken at visit 1 on FRC and TLC breathing levels




Primary Outcome Measures :
  1. CALSA [ Time Frame: 1 day ]
    The primary objective of this study is to compare CALSA with FRI. The respiratory sounds recordings are performed with a digital stethoscope and connected to the sound card of a laptop with commercial software, suitable for data acquisition. The respiratory sounds recordings are conducted in accordance with the Computerized Respiratory Sound Analysis guidelines (CORSA) for short-term acquisition. Subjects are asked to breathe through the mouth in a sitting position (tidal breathing) during the recordings. Three sets of recordings are made for 7 - 10 respiratory cycles with a maximum duration of 25 seconds.


Secondary Outcome Measures :
  1. Total Airway Volume (iVaw) [ Time Frame: 1 day ]
    The secondary objective is to check the repeatability of the FRI parameters

  2. Total Airway Resistance (iRaw) [ Time Frame: 1 day ]
    The secondary objective is to check the repeatability of the FRI parameters.

  3. Internal Airway Distribution [ Time Frame: 1 day ]
    The secondary objective is to check the repeatability of the FRI parameters

  4. Lobar Volume [ Time Frame: 1 day ]
    The secondary objective is to check the repeatability of the FRI parameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228018


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
FLUIDDA nv
Investigators
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Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp

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Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT02228018     History of Changes
Other Study ID Numbers: FLUI-2014-118
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases