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Using electronic nose measurements to capture subgroups of children with asthma.


- candidate number12298
- NTR NumberNTR3410
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-apr-2012
- Secondary IDs2012_019 METC AMC
- Public TitleUsing electronic nose measurements to capture subgroups of children with asthma.
- Scientific TitleUsing electronic nose measurements to capture subgroups of children with asthma.
- ACRONYM
- hypothesisThe analysis of exhaled breath by electronic nose measurements can discriminate between subgroups of children with different levels of asthma control.
- Healt Condition(s) or Problem(s) studiedAsthma control, Children
- Inclusion criteria1. Males and females aged 6 to 17 years (inclusive);
2. Parent/ guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures;
3. Assent should be obtained from all children in the study where appropriate;
4. For children in the asthma groups, the diagnosis of asthma should be given by specialists according to the GINA guidelines;
5. For the control-group children should have no known respiratory or other systemic diseases.
- Exclusion criteria1. Known underlying respiratory tract disease like congenital airway abnormalities, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia or bronchiectasis;
2. Known systemic or inflammatory diseases;
3. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred);
4. The child has had a exacerbation (requiring ER attendance or hospital admission and /or a course of high dose OCS for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 2-mei-2012
- planned closingdate31-dec-2012
- Target number of participants75
- InterventionsThis will be a cross-sectional study. Data will be collected once per patient in a period of 6 months, in the same occasion as their routine visit in the outpatient clinics. Asthma control will be evaluated by (C)ACT questionnaire (in the asthmatic patients). Afterwards exhaled breath, fractional exhaled Nitric Oxide (FeNO) and spirometry measurements will be performed. Spirometry will be measured at last by hand-held spirometer.
- Primary outcome1. Asthma control score;
2. VOCís of breath prints in exhaled air by gas chromatography mass spectrometry (GC-MS) and electronic nose (eNose).
- Secondary outcome1. Fractional exhaled Nitric Oxide;
2. FEV1, PEF.
- TimepointsThis is a cross-sectional study, only one timepoint.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Peter J. Sterk
- CONTACT for SCIENTIFIC QUERIES Simone Hashimoto
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRecent clinical guidelines indicate that asthma management should focus on achieving a good level of asthma control. There seems to be subgroups of patients with remarkable inconsistencies between reported symptoms and the presence of airway inflammation. Therefore, phenotypic evaluation of these patients including reported symptoms and objective parameters of airway inflammation should be considered as the strategy of asthma management. The aim of our study is to explore the possibility of using exhaled breath to discriminate between groups of children with different levels of asthma control.
In this cross-sectional study data will be collected once per patient. Asthma control will be evaluated by questionnaire (in the asthmatic patients). Afterwards exhaled breath, FeNO and spirometry measurements will be performed. Spirometry will be measured at last by hand-held spirometer.
- Main changes (audit trail)
- RECORD25-apr-2012 - 6-mei-2012


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