Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy: a randomised trial (RAACENO)

Steve Turner (Corresponding Author), Seonaidh C. Cotton, Chukwuemeka David Emele, Ruth E. Thomas, Shona A. Fielding, Erol A. Gaillard, Johan C. de Jongste, Heather M. Morgan, Aileen R. Nielson, John Norrie, Mariëlle W. Pijnenburg, David B. Price, Michael Thomas

Research output: Contribution to journalArticle

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 in children with asthma.

Methods. This is a multi-centre, randomised controlled study. Children will be included who are aged 6-16 years with a diagnosis of asthma, currently use inhaled corticosteroids (ICS) 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 changes in FeNO. Participants will attend assessments 3, 6, 9 and 12 months post randomisation. The primary outcome is asthma exacerbation (attack) requiring prescription and/or use of OCS, over 12 months as recorded by participant/parent or in GP 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, bronchodilator response are determined and a saliva sample 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.

[2a and 2b] Trial registration details: ISRCTN 67875351. Registered on 12 April 2017.Prospectively registered.
Original languageEnglish
JournalTrials
Publication statusAccepted/In press - 3 Jun 2019

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Nitric Oxide
Asthma
Biomarkers
Therapeutics
Adrenal Cortex Hormones
Secondary Care
Bronchodilator Agents
Random Allocation
Saliva
Cost-Benefit Analysis
Prescriptions
Primary Health Care
Steroids
Nurses
Maintenance
Quality of Life
Interviews
Equipment and Supplies
Skin
DNA

Cite this

@article{8acf200de03a4d759d31bf217ea539e5,
title = "Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy: a randomised trial (RAACENO)",
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 in children with asthma.Methods. This is a multi-centre, randomised controlled study. Children will be included who are aged 6-16 years with a diagnosis of asthma, currently use inhaled corticosteroids (ICS) 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 changes in FeNO. Participants will attend assessments 3, 6, 9 and 12 months post randomisation. The primary outcome is asthma exacerbation (attack) requiring prescription and/or use of OCS, over 12 months as recorded by participant/parent or in GP 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, bronchodilator response are determined and a saliva sample 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.[2a and 2b] Trial registration details: ISRCTN 67875351. Registered on 12 April 2017.Prospectively registered.",
author = "Steve Turner and Cotton, {Seonaidh C.} and Emele, {Chukwuemeka David} and Thomas, {Ruth E.} and Fielding, {Shona A.} and Gaillard, {Erol A.} and {de Jongste}, {Johan C.} and Morgan, {Heather M.} and Nielson, {Aileen R.} and John Norrie and Pijnenburg, {Mari{\"e}lle W.} and Price, {David B.} and Michael Thomas",
note = "The trial is funded by National Institute of Health (NIHR) Efficacy and Mechanism Evaluation (EME) programme, project number 15-18-14. The funding body had no role in the design of the study and collection or data or the writing of this paper, nor will the funding body have a role in analysis, and interpretation of data and in writing future manuscripts. Acknowledgements The authors are indebted to the following who have helped deliver the RAACENO trial: Mrs J Wood and Mrs V Bell for implementation of protocol; Miss A Fraser for data co-ordination; 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 therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health.",
year = "2019",
month = "6",
day = "3",
language = "English",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy

T2 - a randomised trial (RAACENO)

AU - Turner, Steve

AU - Cotton, Seonaidh C.

AU - Emele, Chukwuemeka David

AU - Thomas, Ruth E.

AU - Fielding, Shona A.

AU - Gaillard, Erol A.

AU - de Jongste, Johan C.

AU - Morgan, Heather M.

AU - Nielson, Aileen R.

AU - Norrie, John

AU - Pijnenburg, Mariëlle W.

AU - Price, David B.

AU - Thomas, Michael

N1 - The trial is funded by National Institute of Health (NIHR) Efficacy and Mechanism Evaluation (EME) programme, project number 15-18-14. The funding body had no role in the design of the study and collection or data or the writing of this paper, nor will the funding body have a role in analysis, and interpretation of data and in writing future manuscripts. Acknowledgements The authors are indebted to the following who have helped deliver the RAACENO trial: Mrs J Wood and Mrs V Bell for implementation of protocol; Miss A Fraser for data co-ordination; 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 therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health.

PY - 2019/6/3

Y1 - 2019/6/3

N2 - 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 in children with asthma.Methods. This is a multi-centre, randomised controlled study. Children will be included who are aged 6-16 years with a diagnosis of asthma, currently use inhaled corticosteroids (ICS) 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 changes in FeNO. Participants will attend assessments 3, 6, 9 and 12 months post randomisation. The primary outcome is asthma exacerbation (attack) requiring prescription and/or use of OCS, over 12 months as recorded by participant/parent or in GP 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, bronchodilator response are determined and a saliva sample 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.[2a and 2b] Trial registration details: ISRCTN 67875351. Registered on 12 April 2017.Prospectively registered.

AB - 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 in children with asthma.Methods. This is a multi-centre, randomised controlled study. Children will be included who are aged 6-16 years with a diagnosis of asthma, currently use inhaled corticosteroids (ICS) 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 changes in FeNO. Participants will attend assessments 3, 6, 9 and 12 months post randomisation. The primary outcome is asthma exacerbation (attack) requiring prescription and/or use of OCS, over 12 months as recorded by participant/parent or in GP 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, bronchodilator response are determined and a saliva sample 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.[2a and 2b] Trial registration details: ISRCTN 67875351. Registered on 12 April 2017.Prospectively registered.

M3 - Article

JO - Trials

JF - Trials

SN - 1745-6215

ER -