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

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Asthma

Cystic Fibrosis

Treatments

Diagnostic Test: inflammation markers in exhaled breath

Study type

Observational

Funder types

Other

Identifiers

NCT03377686

NL 53995.068.15

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

6 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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