Breath Analysis in Children by New Point-of-care Instruments

Maastricht University Medical Center56 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Asthma Cystic Fibrosis

Interventions

inflammation markers in exhaled breathDIAGNOSTIC_TEST

non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Outcomes

Primary Outcomes

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)

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.

Secondary Outcomes

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.

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.

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.

Data from ClinicalTrials.gov

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