Clinical trial NCT03377686: Breath Analysis in Children by New Point-of-care Instruments
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Cystic Fibrosis
Keywords: paediatrics
breath analysis
volatile organic compounds
respiratory diseases
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Exclusion criteria

* 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

Primary outcomes:
measure: Number of participants with adverse events directly related to the various point-of-care tests used
timeFrame: 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:
measure: Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma.
timeFrame: Measurements will be analysed within 6 to 12 months
measure: Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis.
timeFrame: Measurements will be analysed within 6 to 12 months
measure: Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma.
timeFrame: Measurements will be analysed within 6 to 12 months
measure: Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis.
timeFrame: Measurements will be analysed within 6 to 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: Edward Dompeling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.