Cystic FibrosisNCT02368080
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults
An observational study of Cystic Fibrosis and Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Healthy
- What is being tested?
- Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Jan 2014
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CF : primary care clinic HC : community sample
Who may be able to join
- Cystic fibrosis diagnosis
Who cannot join
- Respiratory infection within 3 weeks
- Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults: a Comparison of Two Commercially Available Devices
This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.
Read the detailed description
Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).
- Conditions
- Cystic Fibrosis, Healthy
- Being tested
- Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"
- Keywords
- Lung Clearance Index, Cystic Fibrosis, Multiple Breath Nitrogen Washout
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"Device
Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis adults (CF) | No treatment, comparison of LCI values obtained with two devices Receives: Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D" | |
| Healthy adults (HC) | No treatment, comparison of LCI values obtained with two devices Free of respiratory disease or others diseases likely to disturb respiratory system. Receives: Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Clearance Index (LCI)
Measured: 1 hour
Secondary outcomes (2)
Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)
Difference in discriminative ability between devices will be assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device
Measured: 1 hour
Functional residual capacity (FRC) ( the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)
FRC will be compared with a third device in a subset of 11 healthy adults : the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Patrick Lebecque, MD, PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de LouvainWilliam Poncin, PhD student, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de LouvainAnne-Sophie Aubriot, PhD student, Study chair, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368080
- Sponsor's protocol ID
- StLuc MBWN2 01
- Status last verified
- Jul 2015
- First submitted
- 14 Jan 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults: a Comparison of Two Commercially Available Devices
- ClinicalTrials.gov ID
- NCT02368080
- Acronym / sponsor ID
- StLuc MBWN2 01
- Conditions
- Cystic Fibrosis, Healthy
- Keywords
- Lung Clearance Index, Cystic Fibrosis, Multiple Breath Nitrogen Washout
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Feb 2015 (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.
This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.
Detailed description
Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis adults (CF) | – | Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"No treatment, comparison of LCI values obtained with two devices |
| Healthy adults (HC) | – | Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"No treatment, comparison of LCI values obtained with two devices Free of respiratory disease or others diseases likely to disturb respiratory system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CF : primary care clinic HC : community sample
Key inclusion criteria (1 listed)
- Cystic fibrosis diagnosis
Key exclusion criteria (2 listed)
- Respiratory infection within 3 weeks
- Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia
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 |
|---|---|---|
| Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device. | Device | Cystic fibrosis adults (CF), Healthy adults (HC) |
Primary outcome
Lung Clearance Index (LCI)
Time frame: 1 hour
2 secondary outcomes
Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)
Time frame: 1 hour
Functional residual capacity (FRC) ( the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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.
Patrick Lebecque, MD, PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
William Poncin, PhD student principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Anne-Sophie Aubriot, PhD student study chair
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jul 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lung Clearance Index (LCI) (time frame: 1 hour). 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 30 Jul 2015.