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.

Details

Title
Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy: a randomised trial (RAACENO)
Author
Turner, S. 1   VIAFID ORCID Logo  ; Cotton, S. C. 2 ; Emele, C. D. 2 ; Thomas, R. 2 ; Fielding, S. 3 ; Gaillard, E. A. 4 ; de Jongste, J. C. 5 ; Morgan, H. 6 ; Neilson, A. R. 7 ; Norrie, J. 2 ; Pijnenburg, M. 5 ; Price, D. 8 ; Thomas, M. 9 

1  University of Aberdeen, Child Health, Aberdeen, UK (GRID:grid.7107.1) (ISNI:0000 0004 1936 7291) 
2  University of Aberdeen, Centre for Healthcare Randomised Trials, Aberdeen, UK (GRID:grid.7107.1) (ISNI:0000 0004 1936 7291) 
3  Institute of Applied Health Sciences, University of Aberdeen, Medical Statistics Team, Aberdeen, UK (GRID:grid.7107.1) (ISNI:0000 0004 1936 7291) 
4  University of Leicester, Respiratory Sciences, Leicester, UK (GRID:grid.9918.9) (ISNI:0000 0004 1936 8411) 
5  Erasmus MC – Sophia Children’s Hospital, Department of Paediatric Respiratory Medicine and Allergology, Rotterdam, Netherlands (GRID:grid.416135.4) 
6  Institute of Applied Health Sciences, University of Aberdeen, Postgraduate Education Group, Aberdeen, UK (GRID:grid.7107.1) (ISNI:0000 0004 1936 7291) 
7  Institute of Applied Health Sciences, University of Aberdeen, Health Economics Research Unit, Aberdeen, UK (GRID:grid.7107.1) (ISNI:0000 0004 1936 7291) 
8  Observational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore (GRID:grid.500407.6); University of Aberdeen, Centre of Academic Primary Care, Aberdeen, UK (GRID:grid.7107.1) (ISNI:0000 0004 1936 7291) 
9  University of Southampton, Primary Care and Population Sciences, Southampton, UK (GRID:grid.5491.9) (ISNI:0000 0004 1936 9297); NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK (GRID:grid.454385.b) 
Pages
573
Publication year
2019
Publication date
Dec 2019
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-019-3500-7
ProQuest document ID
2795360321
Copyright
© The Author(s). 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.