AsthmaNCT02950116
Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease
A study testing Perform three multiple breath nitrogen washout tests (N2-MBW-test) in people with Asthma and Bronchiectasis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma, Bronchiectasis, Cystic Fibrosis
- What is being tested?
- Perform three multiple breath nitrogen washout tests (N2-MBW-test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Mar 2017to 7 Apr 2017
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with stable asthma
- Patients with non-CF bronchiectasis
- Patients with cystic fibrosis
- Aged 6-17 years
- FEV1 (%pred) >50%
- Written informed consent from the parents or legal guardian
Who cannot join
- Unstable disease (e.g. pulmonary exacerbation, acute deterioration, acute asthma crisis)
- Patients mentally not capable to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease
Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while asthma is mostly characterized by obstruction due to bronchoconstriction of the airways, obstruction in bronchiectasis and CF originates primarily from mucus retention due to abnormal airway clearance mechanisms.
The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is required for this test makes it very convenient for use in any age category.
Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung disease in asthma children is less clearly demonstrated. No data were found on LCI calculated from the N2-MBW-test in children with bronchiectasis.
Read the detailed description
Subjects of all the intervention groups will perform three consecutive nitrogen multiple breath washout tests (N2-MBW-tests) when attending the Universitair Ziekenhuis Brussel (UZB) for their scheduled pulmonology consultation. Only the best measurement (based on LCI result) will be taken into account when comparing the groups. Every subject will be positioned in the same seated position.
- Conditions
- Asthma, Bronchiectasis, Cystic Fibrosis
- Being tested
- Perform three multiple breath nitrogen washout tests (N2-MBW-test)
- Medical subject headings
- Asthma, Bronchiectasis, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perform three multiple breath nitrogen washout tests (N2-MBW-test)Device
- Patient is sitting in upright position, nose clip in place and breathing through a mouth piece with filter (neither sitting forward with back bent, nor supporting arms such that shoulders are raised)
- Patient's breathing pattern is stable for a minimum of 5 breaths
- Start of washout by inhaling 100% oxygen (initiated by lab technician)
- Continuous stable breathing pattern until end of washout test
- End target = 1/40th of start N2 concentration
- To ensure end of washout is achieved, patients should breathe 5 more breaths below the target concentration before the trial is terminated
- Three N2-MBW-tests are performed consecutively. Time between each test is [duration of the previous test*1.5] (e.g. test duration = 6 min., time to next test = 6*1.5 = 9 min.)
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Active comparator | Asthmatic patients will perform three multiple breath nitrogen washout tests (N2-MBW-test) Receives: Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test) |
| Non-CF bronchiectasis | Active comparator | Patients with non-CF bronchiectasis will perform three multiple breath nitrogen washout tests (N2-MBW-test) Receives: Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test) |
| Cystic fibrosis | Active comparator | Patients with cystic fibrosis will perform three multiple breath nitrogen washout tests (N2-MBW-test) Receives: Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCI
LCI will be calculated from the 3 N2-MBW-tests. The test with the lowest LCI will be used for analysis of the other outcome measurements.
Measured: Day 1
Secondary outcomes (5)
S_cond
S_cond will be calculated from the N2-MBW-test with the lowest LCI
Measured: Day 1
S_acin
S_acin will be calculated from the N2-MBW-test with the lowest LCI
Measured: Day 1
Duration of the N2-MBW-test
Duration of the N2-MBW-test with the lowest LCI will be taken into account for analysis
Measured: Day 1
Number of washout breaths
Will be determined at the end of the N2-MBW-test
Measured: Day 1
FRC
FRC will be calculated from the N2-MBW-test
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start9 Mar 2017
- Primary completion31 Mar 2017
- Study completion7 Apr 2017
Why it stopped: Availabe time for inclusion ended (master thesis)
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.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanneke Eyns, MSc, PT, Principal investigator, UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950116
- Sponsor's protocol ID
- LCI-OLD-ped
- Status last verified
- May 2017
- First submitted
- 11 Oct 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT02950116
- Acronym / sponsor ID
- LCI-OLD-ped
- Conditions
- Asthma, Bronchiectasis, Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Availabe time for inclusion ended (master thesis)
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 31 Oct 2016 (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.
Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while asthma is mostly characterized by obstruction due to bronchoconstriction of the airways, obstruction in bronchiectasis and CF originates primarily from mucus retention due to abnormal airway clearance mechanisms.
The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is required for this test makes it very convenient for use in any age category.
Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung disease in asthma children is less clearly demonstrated. No data were found on LCI calculated from the N2-MBW-test in children with bronchiectasis.
Detailed description
Subjects of all the intervention groups will perform three consecutive nitrogen multiple breath washout tests (N2-MBW-tests) when attending the Universitair Ziekenhuis Brussel (UZB) for their scheduled pulmonology consultation. Only the best measurement (based on LCI result) will be taken into account when comparing the groups. Every subject will be positioned in the same seated position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | Active comparator | Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test)Asthmatic patients will perform three multiple breath nitrogen washout tests (N2-MBW-test) |
| Non-CF bronchiectasis | Active comparator | Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test)Patients with non-CF bronchiectasis will perform three multiple breath nitrogen washout tests (N2-MBW-test) |
| Cystic fibrosis | Active comparator | Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test)Patients with cystic fibrosis will perform three multiple breath nitrogen washout tests (N2-MBW-test) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients with stable asthma
- Patients with non-CF bronchiectasis
- Patients with cystic fibrosis
- Aged 6-17 years
- FEV1 (%pred) >50%
Key exclusion criteria (2 listed)
- Unstable disease (e.g. pulmonary exacerbation, acute deterioration, acute asthma crisis)
- Patients mentally not capable to participate in 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 |
|---|---|---|
| Perform three multiple breath nitrogen washout tests (N2-MBW-test)* Patient is sitting in upright position, nose clip in place and breathing through a mouth piece with filter (neither sitting forward with back bent, nor supporting arms such that shoulders are raised) * Patient's breathing pattern is stable for a minimum of 5 breaths * Start of washout by inhaling 100% oxygen (initiated by lab technician) * Continuous stable breathing pattern until end of washout test * End target = 1/40th of start N2 concentration * To ensure end of washout is achieved, patients should breathe 5 more breaths below the target concentration before the trial is terminated * Three N2-MBW-tests are performed consecutively. Time between each test is [duration of the previous test*1.5] (e.g. test duration = 6 min., time to next test = 6*1.5 = 9 min.) | Device | Asthma, Cystic fibrosis, Non-CF bronchiectasis |
Primary outcome
LCI
Time frame: Day 1
LCI will be calculated from the 3 N2-MBW-tests. The test with the lowest LCI will be used for analysis of the other outcome measurements.
5 secondary outcomes
S_cond
Time frame: Day 1
S_acin
Time frame: Day 1
Duration of the N2-MBW-test
Time frame: Day 1
Number of washout breaths
Time frame: Day 1
FRC
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Availabe time for inclusion ended (master thesis)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- 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.
Hanneke Eyns, MSc, PT principal investigator
UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perform three multiple breath nitrogen washout tests (N2-MBW-test) in people with Asthma and Bronchiectasis, run by Universitair Ziekenhuis Brussel 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 6 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: stopped early, as of the sponsor's last update on 20 Jun 2017. 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 stopped early (reason given: Availabe time for inclusion ended (master thesis)). Results are not available in the source record.
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?
LCI (time frame: Day 1). 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 20 Jun 2017.