An innovative breath test for better care for children with asthma-like symptoms, ADEM2 (Asthma Diagnosis with Exhaled Markers)

An innovative breath test for better care for children with asthma-like symptoms, ADEM2 (Asthma Diagnosis with Exhaled Markers) - Asthma diagnosis by exhaled markers, ADEM2

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52377

Enrollment

320

Registered

2019-04-11

Start date

2019-12-19

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma viral wheeze

Interventions

In WP3, 220 children with asthma-like symptoms will be randomised in an intervention group and an usual care group. In the intervention group at the start of the study, the breath test will be taken

Eligibility

Age

No minimum to 11 Years

Inclusion criteria

Inclusion criteria: Work package (WP)1: 320 children aged 2-3 yrs (n= 220 with asthma-like symptoms, n=100 healthy children) WP2: 220 children aged 2-3 yrs with asthma-like symptoms WP3: 220 children aged 2-3 yrs with asthma-like symptoms

Exclusion criteria

Exclusion criteria: mental disability, cardiac abnormalities, congenital anomalies, other respiratory diseases, chronic inflammatory diseases (e.g. Crohns disease, rheumatoid arthritis), inability to perform the exhaled breath sampling and lung function tests properly.

Design outcomes

Primary

Measure	Time frame
WP1: the main outcome measure is the discriminative exhaled VOCs between asthma, viral wheeze, and healthy controls. WP2: the primary outcome measure is the sensitivity, specificity, true positive and true negative rate of the various VOC sensing techniques for a diagnosis of asthma/viral wheeze in preschool children. WP3: The main outcome parameter is % of well controlled asthma-like symptoms after 1-year follow-up. The % well controlled asthma-like symptoms during the study period will be based on the validated TRACK questionnaire. This questionnaire is completed by the parents and doctors and specifically developed for use in this age group, independent of the diagnosis. A score of 80 or more is defined as well controlled disease. The TRACK score is sensitive and reliable, and an increase of 10 points was found to be the minimally important difference.	—

Measure

Time frame

WP1: the main outcome measure is the discriminative exhaled VOCs between asthma, viral wheeze, and healthy controls. WP2: the primary outcome measure is the sensitivity, specificity, true positive and true negative rate of the various VOC sensing techniques for a diagnosis of asthma/viral wheeze in preschool children. WP3: The main outcome parameter is % of well controlled asthma-like symptoms after 1-year follow-up. The % well controlled asthma-like symptoms during the study period will be based on the validated TRACK questionnaire. This questionnaire is completed by the parents and doctors and specifically developed for use in this age group, independent of the diagnosis. A score of 80 or more is defined as well controlled disease. The TRACK score is sensitive and reliable, and an increase of 10 points was found to be the *minimally important difference*.

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Secondary

Measure	Time frame
In WP1, secondary endpoints in blood are immunological cells, gene expression, epigenetics, and gene polymorphisms. Endpoints in faeces/nasopharyngeal swabs are microbiome and gene expression. In WP2, no secondary endpoints are present. WP3: Secondary outcome parameters are pharmacotherapy, growth retardation and other side-effects of medication, exacerbations/hospital admissions, quality of life, lung function, allergy, blood eosinophils, absence of school and work, healthcare resource use and -costs (standard and extra clinical visits, hospital admissions, referrals), costs outside healthcare, cost-effectiveness, and asthma diagnosis at 6 years.	—

Measure

Time frame

In WP1, secondary endpoints in blood are immunological cells, gene expression, epigenetics, and gene polymorphisms. Endpoints in faeces/nasopharyngeal swabs are microbiome and gene expression. In WP2, no secondary endpoints are present. WP3: Secondary outcome parameters are pharmacotherapy, growth retardation and other side-effects of medication, exacerbations/hospital admissions, quality of life, lung function, allergy, blood eosinophils, absence of school and work, healthcare resource use and -costs (standard and extra clinical visits, hospital admissions, referrals), costs outside healthcare, cost-effectiveness, and asthma diagnosis at 6 years.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)