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

Recruiting

Conditions: Asthma
viral wheeze
10006436

Registration Number: NL-OMON52377

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 320

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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