AsthmaNCT03377686
Breath Analysis in Children by New Point-of-care Instruments
An observational study of Asthma and Cystic Fibrosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Cystic Fibrosis
- What is being tested?
- inflammation markers in exhaled breath
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to Dec 2017
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Who may be able to join
- Children aged 6 to 16 years
- Healthy group: See exclusion criteria
- Asthma group: Doctor's diagnosed asthma
- Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis
Who cannot join
- Recent course of prednisone or antibiotics (< 1 month before test)
- Passive smoking
- Other chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatic disease, auto-immune disease)
- Healthy children:
- No current or history of respiratory symptoms
- No current or history of allergic rhinitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Diagnostic Value of New Point-of-care Instruments for Breath Analysis in Children With Asthma, Cystic Fibrosis (CF), and Healthy Controls
In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques.
Read the detailed description
Rationale: Assessment of volatile organic compounds (VOCs) is a new recently developed non-invasive technique to assess airway inflammation. The non-invasive character makes it highly suitable for use in (preschool) children. However, the analysis of VOCs by gas chromatography mass spectrometry technique (GC-MS), the gold standard, is expensive and time consuming. Therefore, new hand-held devices (such as electronic Noses (eNoses) and Ion Mobility Spectrometer techniques) have been developed. However, these new point-of-care instruments have not been studied in children.
Objectives: 1) To test whether new point-of-care instruments for the measurement of VOCs in exhaled breath are feasible for use in children aged 6 to 16 years; 2) To explore whether these techniques can differentiate between healthy children, asthmatic children and children with Cystic Fibrosis (CF).
Study design: Cross-sectional study design. Several VOCs tests will be performed in all participants.Besides, fraction of exhaled nitric oxide (FeNO) and inflammatory markers in exhaled breath condensate (EBC) will be measured.
Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Main study parameters/endpoints: Each technique will be evaluated for its use and feasibility in children. For each technique, VOC profiles between study groups will be evaluated for its discriminative power.
- Conditions
- Asthma, Cystic Fibrosis
- Being tested
- inflammation markers in exhaled breath
- Keywords
- paediatrics, breath analysis, volatile organic compounds, respiratory diseases
- Medical subject headings
- Asthma, Cystic Fibrosis, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammation markers in exhaled breathDiagnostic test
non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with doctor's diagnosed asthma Receives: Diagnostic Test: inflammation markers in exhaled breath | |
| Cystic fibrosis | Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with CF Receives: Diagnostic Test: inflammation markers in exhaled breath | |
| Healthy | Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years old without respiratory diseases Receives: Diagnostic Test: inflammation markers in exhaled breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events directly related to the various point-of-care tests used
Any adverse event of any kind will be noted. Furthermore, each participant will be asked whether the test was easy to perform. This question can be answered on a 5-point scale (0=totally agree that test was easy to perform, 4= totally disagree that test was easy to perform)
Measured: Questionnaire will be done directly after specific test (1 day). No long term (S)AE is expected and measurement of each test is only performed once.
Secondary outcomes (4)
Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma.
Aeonose eNose measurements will be analysed by in house software program (Aethena) developed by eNose company (Zutphen, Netherlands). To test sensitivity and specificity, first an area under the receiver operating curve must be calculated with the aforementioned software program. Hereafter sensitivity and specificity of the eNose can be calculated.
Measured: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis.
Aeonose eNose measurements will be analysed by in house software program (Aethena) developed by eNose company (Zutphen, Netherlands). To test sensitivity and specificity, first an area under the receiver operating curve must be calculated with the aforementioned software program. Hereafter sensitivity and specificity of the eNose can be calculated.
Measured: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma.
IMS measurements will be analysed by software program developed for using IMS data (Visual Now, Ganshorn, Dortmund, Germany). By IMS different VOCs peaks are generated. By using the aforementioned software, these peaks can be analysed and sensitivity and specificity between asthma and healthy children can be calculated.
Measured: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis.
IMS measurements will be analysed by software program developed for using IMS data (Visual Now, Ganshorn, Dortmund, Germany). By IMS different VOCs peaks are generated. By using the aforementioned software, these peaks can be analysed and sensitivity and specificity between CF and healthy children can be calculated.
Measured: Measurements will be analysed within 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study startMar 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Dompeling, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377686
- Sponsor's protocol ID
- NL 53995.068.15
- Status last verified
- Nov 2017
- First submitted
- 29 Jan 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bannier MAGE, van de Kant KDG, Jobsis Q, Dompeling E. Feasibility and diagnostic accuracy of an electronic nose in children with asthma and cystic fibrosis. J Breath Res. 2019 May 8;13(3):036009. doi: 10.1088/1752-7163/aae158.
PubMed 30213921
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Diagnostic Value of New Point-of-care Instruments for Breath Analysis in Children With Asthma, Cystic Fibrosis (CF), and Healthy Controls
- ClinicalTrials.gov ID
- NCT03377686
- Acronym / sponsor ID
- NL 53995.068.15
- Conditions
- Asthma, Cystic Fibrosis
- Keywords
- paediatrics, breath analysis, volatile organic compounds, respiratory diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Dec 2017 (actual)
- 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.
In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques.
Detailed description
Rationale: Assessment of volatile organic compounds (VOCs) is a new recently developed non-invasive technique to assess airway inflammation. The non-invasive character makes it highly suitable for use in (preschool) children. However, the analysis of VOCs by gas chromatography mass spectrometry technique (GC-MS), the gold standard, is expensive and time consuming. Therefore, new hand-held devices (such as electronic Noses (eNoses) and Ion Mobility Spectrometer techniques) have been developed. However, these new point-of-care instruments have not been studied in children.
Objectives: 1) To test whether new point-of-care instruments for the measurement of VOCs in exhaled breath are feasible for use in children aged 6 to 16 years; 2) To explore whether these techniques can differentiate between healthy children, asthmatic children and children with Cystic Fibrosis (CF).
Study design: Cross-sectional study design. Several VOCs tests will be performed in all participants.Besides, fraction of exhaled nitric oxide (FeNO) and inflammatory markers in exhaled breath condensate (EBC) will be measured.
Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Main study parameters/endpoints: Each technique will be evaluated for its use and feasibility in children. For each technique, VOC profiles between study groups will be evaluated for its discriminative power.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Diagnostic Test: inflammation markers in exhaled breathInflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with doctor's diagnosed asthma |
| Cystic fibrosis | – | Diagnostic Test: inflammation markers in exhaled breathInflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with CF |
| Healthy | – | Diagnostic Test: inflammation markers in exhaled breathInflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years old without respiratory diseases |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Key inclusion criteria (4 listed)
- Children aged 6 to 16 years
- Healthy group: See exclusion criteria
- Asthma group: Doctor's diagnosed asthma
- Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis
Key exclusion criteria (6 listed)
- Recent course of prednisone or antibiotics (< 1 month before test)
- Passive smoking
- Other chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatic disease, auto-immune disease)
- Healthy children:
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 |
|---|---|---|
| inflammation markers in exhaled breathnon-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational) | Diagnostic test | Asthma, Cystic fibrosis, Healthy |
Primary outcome
Number of participants with adverse events directly related to the various point-of-care tests used
Time frame: Questionnaire will be done directly after specific test (1 day). No long term (S)AE is expected and measurement of each test is only performed once.
Any adverse event of any kind will be noted. Furthermore, each participant will be asked whether the test was easy to perform. This question can be answered on a 5-point scale (0=totally agree that test was easy to perform, 4= totally disagree that test was easy to perform)
4 secondary outcomes
Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma.
Time frame: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis.
Time frame: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma.
Time frame: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis.
Time frame: Measurements will be analysed within 6 to 12 months
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 19 Dec 2017.
- Derived from this study: PubMed 30213921Bannier MAGE, van de Kant KDG, Jobsis Q, Dompeling E. Feasibility and diagnostic accuracy of an electronic nose in children with asthma and cystic fibrosis. J Breath Res. 2019 May 8;13(3):036009. doi: 10.1088/1752-7163/aae158.
- 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.
Edward Dompeling, MD, PhD principal investigator
Maastricht University Medical Centre
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 Asthma and Cystic Fibrosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 6 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 19 Dec 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 Netherlands. 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?
Number of participants with adverse events directly related to the various point-of-care tests used (time frame: Questionnaire will be done directly after specific test (1 day). No long term (S)AE is expected and measurement of each test is only performed once.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377686, which also lists 1 linked publication.
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 19 Dec 2017.