The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children
Abstract Background The prevalence of asthma-like symptoms in preschool children is high. Despite numerous efforts, there still is no clinically available diagnostic tool to discriminate asthmatic children from children with transient wheeze at preschool age. This leads to potential overtreatment of...
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| Format: | Article |
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BMC
2023-04-01
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| Series: | BMC Public Health |
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| Online Access: | https://doi.org/10.1186/s12889-023-15465-6 |
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| author | Sophie Kienhorst Moniek H. D. van Aarle Quirijn Jöbsis Michiel A. G. E. Bannier Elin T. G. Kersten Jan Damoiseaux Onno C. P. van Schayck Peter J. F. M. Merkus Gerard H. Koppelman Frederik-Jan van Schooten ADEM2 Consortium Agnieszka Smolinska Edward Dompeling |
| author_facet | Sophie Kienhorst Moniek H. D. van Aarle Quirijn Jöbsis Michiel A. G. E. Bannier Elin T. G. Kersten Jan Damoiseaux Onno C. P. van Schayck Peter J. F. M. Merkus Gerard H. Koppelman Frederik-Jan van Schooten ADEM2 Consortium Agnieszka Smolinska Edward Dompeling |
| author_sort | Sophie Kienhorst |
| collection | DOAJ |
| description | Abstract Background The prevalence of asthma-like symptoms in preschool children is high. Despite numerous efforts, there still is no clinically available diagnostic tool to discriminate asthmatic children from children with transient wheeze at preschool age. This leads to potential overtreatment of children outgrowing their symptoms, and to potential undertreatment of children who turn out to have asthma. Our research group developed a breath test (using GC-tof–MS for VOC-analysis in exhaled breath) that is able to predict a diagnosis of asthma at preschool age. The ADEM2 study assesses the improvement in health gain and costs of care with the application of this breath test in wheezing preschool children. Methods This study is a combination of a multi-centre, parallel group, two arm, randomised controlled trial and a multi-centre longitudinal observational cohort study. The preschool children randomised into the treatment arm of the RCT receive a probability diagnosis (and corresponding treatment recommendations) of either asthma or transient wheeze based on the exhaled breath test. Children in the usual care arm do not receive a probability diagnosis. Participants are longitudinally followed up until the age of 6 years. The primary outcome is disease control after 1 and 2 years of follow-up. Participants of the RCT, together with a group of healthy preschool children, also contribute to the parallel observational cohort study developed to assess the validity of alternative VOC-sensing techniques and to explore numerous other potential discriminating biological parameters (such as allergic sensitisation, immunological markers, epigenetics, transcriptomics, microbiomics) and the subsequent identification of underlying disease pathways and relation to the discriminative VOCs in exhaled breath. Discussion The potential societal and clinical impact of the diagnostic tool for wheezing preschool children is substantial. By means of the breath test, it will become possible to deliver customized and high qualitative care to the large group of vulnerable preschool children with asthma-like symptoms. By applying a multi-omics approach to an extensive set of biological parameters we aim to explore (new) pathogenic mechanisms in the early development of asthma, creating potentially interesting targets for the development of new therapies. Trial registration Netherlands Trial Register, NL7336, Date registered 11–10-2018. |
| first_indexed | 2024-04-09T18:50:14Z |
| format | Article |
| id | doaj.art-16e3fb5172d64d0b88f64060fca3fe75 |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-04-09T18:50:14Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-16e3fb5172d64d0b88f64060fca3fe752023-04-09T11:29:00ZengBMCBMC Public Health1471-24582023-04-0123112010.1186/s12889-023-15465-6The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool childrenSophie Kienhorst0Moniek H. D. van Aarle1Quirijn Jöbsis2Michiel A. G. E. Bannier3Elin T. G. Kersten4Jan Damoiseaux5Onno C. P. van Schayck6Peter J. F. M. Merkus7Gerard H. Koppelman8Frederik-Jan van Schooten9ADEM2 ConsortiumAgnieszka Smolinska10Edward Dompeling11Department of Paediatric Pulmonology, Maastricht University Medical CentreDepartment of Paediatric Pulmonology, Maastricht University Medical CentreDepartment of Paediatric Pulmonology, Maastricht University Medical CentreDepartment of Paediatric Pulmonology, Maastricht University Medical CentreDepartment of Paediatric Pulmonology and Pediatric Allergology, Beatrix Children’s Hospital, and GRIAC Research Institute, University Medical Centre Groningen, University of GroningenCentral Diagnostic Laboratory, Maastricht University Medical CentreDepartment of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht UniversityDepartment of Paediatric Pulmonology, Radboud University Medical CentreDepartment of Paediatric Pulmonology and Pediatric Allergology, Beatrix Children’s Hospital, and GRIAC Research Institute, University Medical Centre Groningen, University of GroningenDepartment Pharmacology and Toxicology, Faculty of Health, Medicine and Life Sciences, Maastricht UniversityDepartment Pharmacology and Toxicology, Faculty of Health, Medicine and Life Sciences, Maastricht UniversityDepartment of Paediatric Pulmonology, Maastricht University Medical CentreAbstract Background The prevalence of asthma-like symptoms in preschool children is high. Despite numerous efforts, there still is no clinically available diagnostic tool to discriminate asthmatic children from children with transient wheeze at preschool age. This leads to potential overtreatment of children outgrowing their symptoms, and to potential undertreatment of children who turn out to have asthma. Our research group developed a breath test (using GC-tof–MS for VOC-analysis in exhaled breath) that is able to predict a diagnosis of asthma at preschool age. The ADEM2 study assesses the improvement in health gain and costs of care with the application of this breath test in wheezing preschool children. Methods This study is a combination of a multi-centre, parallel group, two arm, randomised controlled trial and a multi-centre longitudinal observational cohort study. The preschool children randomised into the treatment arm of the RCT receive a probability diagnosis (and corresponding treatment recommendations) of either asthma or transient wheeze based on the exhaled breath test. Children in the usual care arm do not receive a probability diagnosis. Participants are longitudinally followed up until the age of 6 years. The primary outcome is disease control after 1 and 2 years of follow-up. Participants of the RCT, together with a group of healthy preschool children, also contribute to the parallel observational cohort study developed to assess the validity of alternative VOC-sensing techniques and to explore numerous other potential discriminating biological parameters (such as allergic sensitisation, immunological markers, epigenetics, transcriptomics, microbiomics) and the subsequent identification of underlying disease pathways and relation to the discriminative VOCs in exhaled breath. Discussion The potential societal and clinical impact of the diagnostic tool for wheezing preschool children is substantial. By means of the breath test, it will become possible to deliver customized and high qualitative care to the large group of vulnerable preschool children with asthma-like symptoms. By applying a multi-omics approach to an extensive set of biological parameters we aim to explore (new) pathogenic mechanisms in the early development of asthma, creating potentially interesting targets for the development of new therapies. Trial registration Netherlands Trial Register, NL7336, Date registered 11–10-2018.https://doi.org/10.1186/s12889-023-15465-6AsthmaPreschoolWheezeDiagnosisExhaled VOCBreath test |
| spellingShingle | Sophie Kienhorst Moniek H. D. van Aarle Quirijn Jöbsis Michiel A. G. E. Bannier Elin T. G. Kersten Jan Damoiseaux Onno C. P. van Schayck Peter J. F. M. Merkus Gerard H. Koppelman Frederik-Jan van Schooten ADEM2 Consortium Agnieszka Smolinska Edward Dompeling The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children BMC Public Health Asthma Preschool Wheeze Diagnosis Exhaled VOC Breath test |
| title | The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children |
| title_full | The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children |
| title_fullStr | The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children |
| title_full_unstemmed | The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children |
| title_short | The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children |
| title_sort | adem2 project early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children |
| topic | Asthma Preschool Wheeze Diagnosis Exhaled VOC Breath test |
| url | https://doi.org/10.1186/s12889-023-15465-6 |
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