Asthma, Cystic Fibrosis
Conditions
Keywords
paediatrics, breath analysis, volatile organic compounds, respiratory diseases
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTinflammation markers in exhaled breath
non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)
Sponsors
Maastricht University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events directly related to the various point-of-care tests used | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis. | Measurements will be analysed within 6 to 12 months | 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. |
| Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma. | Measurements will be analysed within 6 to 12 months | 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. |
| Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma. | Measurements will be analysed within 6 to 12 months | 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. |
| Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis. | Measurements will be analysed within 6 to 12 months | 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. |
Countries
Netherlands
Outcome results
None listed