Abstract
Background
Childhood asthma is a common condition. Currently there is no validated objective test which can be used to guide asthma treatment in children. This study tests the hypothesis that the addition of fractional exhaled nitric oxide (FENO) monitoring in addition to standard care reduces the number of exacerbations (or attacks) in children with asthma.
Methods
This is a multi-centre, randomised controlled study. Children will be included of age 6–16 years who have a diagnosis of asthma, currently use inhaled corticosteroids (ICSs) and have had an exacerbation in the previous 12 months. Exclusion criteria include being unable to provide FENO measurement at baseline assessment, having another chronic respiratory condition and being currently treated with maintenance oral steroids. Participants will be recruited in both primary and secondary care settings and will be randomised to either receive asthma treatment guided by FENO plus symptoms (FENO group) or asthma treatment guided by symptoms only (standard care group). Within the FENO group, different treatment decisions will be made dependent on changes in FENO. Participants will attend assessments 3, 6, 9 and 12 months post randomisation. The primary outcome is asthma exacerbation requiring prescription and/or use of an oral corticosteroid over 12 months as recorded by the participant/parent or in general practitioner records. Secondary outcomes include time to first attack, number of attacks, asthma control score and quality of life. Adherence to ICS treatment is objectively measured by an electronic logging device. Participants are invited to participate in a “phenotyping” assessment where skin prick reactivity and bronchodilator response are determined and a saliva sample is collected for DNA extraction. Qualitative interviews will be held with participants and research nurses. A health economic evaluation will take place.
Discussion
This study will evaluate whether FENO can provide an objective index to guide and stratify asthma treatment in children.
Trial registration
ISRCTN, ISRCTN67875351. Registered on 12 April 2017. Prospectively registered.
Childhood asthma is a common condition. Currently there is no validated objective test which can be used to guide asthma treatment in children. This study tests the hypothesis that the addition of fractional exhaled nitric oxide (FENO) monitoring in addition to standard care reduces the number of exacerbations (or attacks) in children with asthma.
Methods
This is a multi-centre, randomised controlled study. Children will be included of age 6–16 years who have a diagnosis of asthma, currently use inhaled corticosteroids (ICSs) and have had an exacerbation in the previous 12 months. Exclusion criteria include being unable to provide FENO measurement at baseline assessment, having another chronic respiratory condition and being currently treated with maintenance oral steroids. Participants will be recruited in both primary and secondary care settings and will be randomised to either receive asthma treatment guided by FENO plus symptoms (FENO group) or asthma treatment guided by symptoms only (standard care group). Within the FENO group, different treatment decisions will be made dependent on changes in FENO. Participants will attend assessments 3, 6, 9 and 12 months post randomisation. The primary outcome is asthma exacerbation requiring prescription and/or use of an oral corticosteroid over 12 months as recorded by the participant/parent or in general practitioner records. Secondary outcomes include time to first attack, number of attacks, asthma control score and quality of life. Adherence to ICS treatment is objectively measured by an electronic logging device. Participants are invited to participate in a “phenotyping” assessment where skin prick reactivity and bronchodilator response are determined and a saliva sample is collected for DNA extraction. Qualitative interviews will be held with participants and research nurses. A health economic evaluation will take place.
Discussion
This study will evaluate whether FENO can provide an objective index to guide and stratify asthma treatment in children.
Trial registration
ISRCTN, ISRCTN67875351. Registered on 12 April 2017. Prospectively registered.
| Original language | English |
|---|---|
| Article number | 573 |
| Number of pages | 11 |
| Journal | Trials |
| Volume | 20 |
| Early online date | 4 Oct 2019 |
| DOIs | |
| Publication status | Published - 2019 |
Bibliographical note
AcknowledgementsThe authors are indebted to the following persons who have helped deliver the RAACENO trial: Mrs J Wood and Mrs V Bell for implementation of protocol; Miss A Fraser for data coordination; colleagues in the Clinical Trials Unit in Aberdeen (Centre for Healthcare Randomised Trials, CHaRT); the Clinical Research Networks in East of England; the Scottish Primary Care Research Network; the local recruiting teams, participants and participant parents and care givers.
The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, National Institute for Health Research (NIHR), NHS or the Department of Health.
Funding {4}
The trial is funded by the NIHR Efficacy and Mechanism Evaluation (EME) programme, project number 15-18-14. The funding body had no role in the design of the study, collection of data or the writing of this paper, nor will the funding body have a role in analysis, interpretation of data or in writing future manuscripts.
Co-sponsor 1 is the University of Aberdeen, Foresterhill House Annexe, Foresterhill, Aberdeen, AB25 2ZB.
Co-sponsor 2 is NHS Grampian, Foresterhill House Annexe, Foresterhill, Aberdeen, AB25 2ZB.
Keywords
- SPUTUM EOSINOPHIL COUNTS
- AIRWAY INFLAMMATION
- LUNG-FUNCTION