An innovative breath test for better care for children with asthma-like symptoms

The objective is to study improvement in health gain and costs of care with the application of a breath test in wheezing preschool children. A multicentre RCT in 220 preschool wheezing children will be performed. The participating centres are all located in the Netherlands: UMC-Groningen, UMC-Nijmegen, Maastricht UMC+, RNFM [Research Network Family Medicine Maastricht] and Zuyderland. Exhaled breath will be collected and analysed with the gold standard (GC-MS). An algorithm based diagnosis will be assessed (ADEM1). Children will be randomised into an intervention group (n=110), in which the doctors and parents will be informed about the diagnosis, or a usual care group (n=110) which is masked for the diagnosis. Children diagnosed with asthma in the intervention group will receive medication according to the asthma guidelines, whereas medication use and referral will be avoided in children with a viral wheeze diagnosis. The usual care group will be treated according to the current practice. Children will be followed up until 6 years of age at which age a definite diagnosis (asthma versus viral wheeze) is made.

1) an early asthma diagnosis with the breath test will improve disease control, quality of life of children and parents, optimise treatment and thereby improve the prognosis of wheezing children. The use of the breath test will considerably reduce unnecessary burden and costs of the health care system by significantly reducing referral to secondary/tertiary care centres, diminishing use of asthma medication in ‘viral wheeze’ children, and by reducing loss of asthma control/exacerbations/hospital admissions in children with asthma.

2) GC-MS breath test can be developed into a point-of-care breath test which provides immediate results and is affordable for both primary care and specialist care.
3) the predictive VOCs of an early diagnosis (discovered in the ADEM1 study) point to important underlying pathogenetic pathways of an early asthma development.

Primary outcoume : Disease control (TRACK)

Timepoints: baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, final measurements at age 6 years.

Secondary outcomes:

- Side-effects: continuous registration.

- Exacerbation: continuous registration.

- Pharmacotherapy: continuous registration.

- Costs/Healthcare: baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, final measurements at age 6 years.

- Quality of life: baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, final measurements at age 6 years.

- Lungfunction: baseline, 12 months, 24 months, 36 months, final measurements at age 6 years.

- Breath test: baseline, 12 months, 24 months, 36 months, final measurements at age 6 years.

- Growth: baseline, 12 months, 24 months, 36 months, final measurements at age 6 years.

- Atopy/eosinophils, gene expression, immunological cells, microbiome, epigenomics, gene polymophisms.: baseline, final measurements at age 6 years.

- Final diagnosis: final measurements at age 6 years.

Children will be randomised into an intervention group (n=110), in which the doctors and parents will be informed about the diagnosis, or a ‘usual care’ (control) group (n=110), in which the diagnosis is unknown until the end of the trial. Children diagnosed with asthma in the intervention group will receive medication according to the asthma guidelines, whereas medication use and referral to a specialist can be avoided in children with a viral wheeze diagnosis. The usual care group will be treated according to the current clinical practice.