AsthmaNCT02228018
The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers
A study testing CT-scan in people with Asthma, run by FLUIDDA nv at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- CT-scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- CT-scan
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scanDevice
CT-Scan will be taken at visit 1 on FRC and TLC breathing levels
| Study group | Role | What they receive |
|---|---|---|
| CALSA and FRI repeatability | Experimental | CT-Scan No medication used Receives: Device: CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
CALSA
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.
Measured: 1 day
Secondary outcomes (4)
Total Airway Volume (iVaw)
The secondary objective is to check the repeatability of the FRI parameters
Measured: 1 day
Total Airway Resistance (iRaw)
The secondary objective is to check the repeatability of the FRI parameters.
Measured: 1 day
Internal Airway Distribution
The secondary objective is to check the repeatability of the FRI parameters
Measured: 1 day
Lobar Volume
The secondary objective is to check the repeatability of the FRI parameters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startMar 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Other strategies followed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228018
- Sponsor's protocol ID
- FLUI-2014-118
- Status last verified
- Jan 2016
- First submitted
- 25 Aug 2014
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02228018
- Acronym / sponsor ID
- FLUI-2014-118
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other strategies followed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CALSA and FRI repeatability | Experimental | Device: CT-scanCT-Scan No medication used |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-scanCT-Scan will be taken at visit 1 on FRC and TLC breathing levels | Device | CALSA and FRI repeatability |
Primary outcome
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.
4 secondary outcomes
Total Airway Volume (iVaw)
Time frame: 1 day
Total Airway Resistance (iRaw)
Time frame: 1 day
Internal Airway Distribution
Time frame: 1 day
Lobar Volume
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried De Backer, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-scan in people with Asthma, run by FLUIDDA nv at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CALSA (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.