Skip to content

The reliability of new point-of-care instruments for breath analysis in children with asthma and cystic fibrosis (CF), and healthy controls

The reliability of new point-of-care instruments for breath analysis in children with asthma and cystic fibrosis (CF), and healthy controls - Breath analysis in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44692
Enrollment
60
Registered
2015-08-19
Start date
2016-03-03
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

asthma cystic fibrosis (CF)

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Study Population: 3 groups of children and adolescents aged 6-20 years will be randomly selected: * 20 healthy children and adolescents * 20 children and adolescents with asthma * 20 children and adolescents with CF;Inclusion criteria: * Children and adolescents aged 6 to 20 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

Exclusion criteria: Exclusion criteria: * Recent course of prednisone or antibiotics (

Design outcomes

Primary

MeasureTime frame
Exhaled nitric oxide test and exhaled breath condensate (EBC): Fraction of exhaled nitric oxide (FeNO) will be obtained with the online NIOX analyser (Aerocrine, Solna, Sweden) according to ATS/ERS standards [12]. FeNO is currently considered as gold standard test for non-invasive measurement of lung inflammation.EBC will be collected by means of an optimised glass tube, cooled by counter-current circulating ice water, as described previously [2]. Children breathe tidally for ten minutes, while wearing a nose-clip, through a mouthpiece connected to a two-way non-rebreathing valve (Hans Rudolph Inc, series 1420, Kansas City, USA). The two-way valve and tubing to the condenser, serves as a saliva trap. After collection, EBC was rapidly frozen at -80°C using dry ice and was stored at -80ºC until analysis. Inflammatory markers and microbiome will be determined in EBC and compared to VOCs profiles as gold standard for airway inflammation. VOCs in exhaled breath: For analysis of VOCs the following exhaled breath techniques will be used: * eNose Aeonose® from The eNose Company [6] * Ion mobility Spectrometer (IMS) from Ganshorn [8] * Gas chromatography mass spectrometry (GC-MS) from Ganshorn (gold standard VOCs analysis) All techniques will be randomly studied in all participants. Procedure of exhaled VOCs techniques: The child/adolescent will be asked to breath tidally through a mouth piece into the eNose/IMS. The duration of the procedure depends on the technique but will not exceed 5 to 10 minutes. After a pause of 10 minutes the next technique will be performed, and so on. The total duration of testing will be approximately 60 minutes. Eating and exercise are prohibited within 60 minutes prior to testing. Drinking of water is allowed prior to and in between tests. Use of inhalation medication will be stopped 3 hours before measurements. All techniques are completely non-invasive. In case of resistance of the child, the measurements will be

Secondary

MeasureTime frame
References: 1. Dallinga JW, Robroeks CM, van Berkel JJ, Moonen EJ, Godschalk RW, Jöbsis Q, Dompeling E, Wouters EF, van Schooten FJ. Volatile organic compounds in exhaled breath as a diagnostic tool for asthma in children. Clin Exp Allergy 2010;40(1):68-76. 2. Klaassen EM, van de Kant KD, Jöbsis Q, van Schayck OC, Smolinska A, Dallinga JW, van Schooten FJ, den Hartog GJ, de Jongste JC, Rijkers GT, Dompeling E. Exhaled biomarkers and gene expression at preschool age improve asthma prediction at 6 years of age. Am J Respir Crit Care Med 2015;191(2):201-7. 3. Robroeks CM, van Berkel JJ, Dallinga JW, Jöbsis Q, Zimmermann LJ, Hendriks HJ, Wouters MF, van der Grinten CP, van de Kant KD, van Schooten FJ, Dompeling E. Metabolomics of volatile organic compounds in cystic fibrosis patients and controls. Pediatr Res 2010;68(1):75-80. 4. Fens N, van der Schee MP, Brinkman P, Sterk PJ. Exhaled breath analysis by electronic nose in airways disease. Established issues and key questions. Clin Exp Allergy 2013;43:705-715. 5. Van der Schee MP, Paff T, Brinkman P, van Aalderen WMC, Haarman EG, Sterk PJ. Breathomics in lung disease. Chest 2015;147(1):224-231. 6. Product information Aeonose, The eNose company: http://www.enose.nl/products/aeonose/. 7. Product information eNose, Common Invent: http://www.comon-invent.com/enose/ 8. Product information Ion Mobility Spectrometer, Ganshorn: http://www.ganshorn.nl/index.php?option=com_content&view=article&id=22&Itemid=23 8. 9. Asher MI, Montefort S, Bjorksten B, Lai CK, Strachan DP, Weiland SK, Williams H: Worldwide time trends in the prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and eczema in childhood: ISAAC Phases One and Three repeat multicountry cross-sectional surveys. Lancet 2006;368(9537):733-743. 10. ISAAC questionnaire: http://isaac.auckland.ac.nz/resources/tools.php?menu=tools1 11. Juniper EF, Gruffydd-Jones K, Ward S, Svensson K. Asthma Control Questionnaire in children: validation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)