FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations

Andrew Skeggs; Tricia McKeever; Lelia Duley; Eleanor Mitchell; Lucy Bradshaw; Kevin Mortimer; Samantha Walker; Steve Parrott; Andrew Wilson; Ian Pavord; Chris Brightling; Mike Thomas; David Price; Graham Devereux; Bernard Higgins; Tim Harrison; Rebecca Haydock

doi:10.1186/s13063-016-1608-6

FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations

Andrew Skeggs, Tricia McKeever, Lelia Duley, Eleanor Mitchell, Lucy Bradshaw, Kevin Mortimer, Samantha Walker, Steve Parrott, Andrew Wilson, Ian Pavord, Chris Brightling, Mike Thomas, David Price, Graham Devereux, Bernard Higgins, Tim Harrison, Rebecca Haydock

Research output: Contribution to journal › Article › peer-review

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Abstract

BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan. There are a variety of reasons for this but uncertainty about what to include in the plan when asthma control is deteriorating, but before the need for orally administered corticosteroids, is a contributing factor. The aim of this trial is to determine whether an asthma self-management plan, which includes a temporary quadrupling of the dose of inhaled corticosteroid when asthma control starts to deteriorate, reduces asthma exacerbations requiring orally administered corticosteroids or unscheduled health care consultation for asthma.

METHODS: A multicentre, pragmatic, randomised trial in adults aged over 16 years with a clinical diagnosis of asthma, treated with a licensed dose of inhaled corticosteroid and at least one exacerbation in the previous 12 months requiring treatment with systemic corticosteroids. Participants will be randomised to either a self-management plan, which includes a temporary (maximum of 14 days) fourfold increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid. Participants will be followed up at 6 and 12 months and will attend the clinic for an additional visit if their asthma control deteriorates. The primary outcome is time to first asthma exacerbation, defined as the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. The estimated sample size is 1800 participants.

DISCUSSION: The FAST trial is an independent study that has been prioritised and commissioned by the National Institute for Health Research (NIHR) in the United Kingdom. It will provide high-quality evidence to inform clinical decision-making on the role of an asthma self-management plan, which includes a temporary fourfold increase of inhaled corticosteroid, when asthma control starts to deteriorate. The first participant was randomised on 17th May 2013 and recruitment will close on 31 January 2016 with the last patient last visit taking place in January 2017.

TRIAL REGISTRATION: ISRCTN: 15441965 , registered on 25 April 2013.

Original language	English
Article number	499
Journal	Trials
Volume	17
DOIs	https://doi.org/10.1186/s13063-016-1608-6
Publication status	Published - 13 Oct 2016

Bibliographical note

This project was funded by the National Institute for Health Research Health
Technology Assessment Programme (project number 10/143/01). 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.
The trial is sponsored by the University of Nottingham and supported by the
NIHR Clinical Research Network.
The Trial Management Committee we would like to thank all of the
coapplicants on the grant application and protocol for their scientific
contribution to the trial, and the East Midlands Clinical Research Network
(CRN) which is acting as lead CRN for the study. We would also like to thank
the participating local CRNs that helped to facilitate primary care research in
their region and all the participating research sites for their contribution to
recruitment.

Keywords

asthma
exacerbation
self-management plan
inhaled corticosteroids
oral corticosteroids Randomised controlled trial
fourfold
protocol
primary care

Access to Document

10.1186/s13063-016-1608-6Licence: CC BY

FourFold Asthma Study (FAST)
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Skeggs, A., McKeever, T., Duley, L., Mitchell, E., Bradshaw, L., Mortimer, K., Walker, S., Parrott, S., Wilson, A., Pavord, I., Brightling, C., Thomas, M., Price, D., Devereux, G., Higgins, B., Harrison, T., & Haydock, R. (2016). FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations. Trials, 17, Article 499. https://doi.org/10.1186/s13063-016-1608-6

FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations. / Skeggs, Andrew; McKeever, Tricia; Duley, Lelia et al.
In: Trials, Vol. 17, 499, 13.10.2016.

Research output: Contribution to journal › Article › peer-review

Skeggs, A, McKeever, T, Duley, L, Mitchell, E, Bradshaw, L, Mortimer, K, Walker, S, Parrott, S, Wilson, A, Pavord, I, Brightling, C, Thomas, M, Price, D, Devereux, G, Higgins, B, Harrison, T & Haydock, R 2016, 'FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations', Trials, vol. 17, 499. https://doi.org/10.1186/s13063-016-1608-6

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abstract = "BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan. There are a variety of reasons for this but uncertainty about what to include in the plan when asthma control is deteriorating, but before the need for orally administered corticosteroids, is a contributing factor. The aim of this trial is to determine whether an asthma self-management plan, which includes a temporary quadrupling of the dose of inhaled corticosteroid when asthma control starts to deteriorate, reduces asthma exacerbations requiring orally administered corticosteroids or unscheduled health care consultation for asthma.METHODS: A multicentre, pragmatic, randomised trial in adults aged over 16 years with a clinical diagnosis of asthma, treated with a licensed dose of inhaled corticosteroid and at least one exacerbation in the previous 12 months requiring treatment with systemic corticosteroids. Participants will be randomised to either a self-management plan, which includes a temporary (maximum of 14 days) fourfold increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid. Participants will be followed up at 6 and 12 months and will attend the clinic for an additional visit if their asthma control deteriorates. The primary outcome is time to first asthma exacerbation, defined as the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. The estimated sample size is 1800 participants.DISCUSSION: The FAST trial is an independent study that has been prioritised and commissioned by the National Institute for Health Research (NIHR) in the United Kingdom. It will provide high-quality evidence to inform clinical decision-making on the role of an asthma self-management plan, which includes a temporary fourfold increase of inhaled corticosteroid, when asthma control starts to deteriorate. The first participant was randomised on 17th May 2013 and recruitment will close on 31 January 2016 with the last patient last visit taking place in January 2017.TRIAL REGISTRATION: ISRCTN: 15441965 , registered on 25 April 2013.",

keywords = "asthma, exacerbation, self-management plan, inhaled corticosteroids, oral corticosteroids Randomised controlled trial, fourfold, protocol, primary care",

author = "Andrew Skeggs and Tricia McKeever and Lelia Duley and Eleanor Mitchell and Lucy Bradshaw and Kevin Mortimer and Samantha Walker and Steve Parrott and Andrew Wilson and Ian Pavord and Chris Brightling and Mike Thomas and David Price and Graham Devereux and Bernard Higgins and Tim Harrison and Rebecca Haydock",

note = "This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 10/143/01). 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. The trial is sponsored by the University of Nottingham and supported by the NIHR Clinical Research Network. The Trial Management Committee we would like to thank all of the coapplicants on the grant application and protocol for their scientific contribution to the trial, and the East Midlands Clinical Research Network (CRN) which is acting as lead CRN for the study. We would also like to thank the participating local CRNs that helped to facilitate primary care research in their region and all the participating research sites for their contribution to recruitment.",

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T2 - a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations

AU - Skeggs, Andrew

AU - McKeever, Tricia

AU - Duley, Lelia

AU - Mitchell, Eleanor

AU - Bradshaw, Lucy

AU - Mortimer, Kevin

AU - Walker, Samantha

AU - Parrott, Steve

AU - Wilson, Andrew

AU - Pavord, Ian

AU - Brightling, Chris

AU - Thomas, Mike

AU - Price, David

AU - Devereux, Graham

AU - Higgins, Bernard

AU - Harrison, Tim

AU - Haydock, Rebecca

N1 - This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 10/143/01). 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. The trial is sponsored by the University of Nottingham and supported by the NIHR Clinical Research Network. The Trial Management Committee we would like to thank all of the coapplicants on the grant application and protocol for their scientific contribution to the trial, and the East Midlands Clinical Research Network (CRN) which is acting as lead CRN for the study. We would also like to thank the participating local CRNs that helped to facilitate primary care research in their region and all the participating research sites for their contribution to recruitment.

PY - 2016/10/13

Y1 - 2016/10/13

N2 - BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan. There are a variety of reasons for this but uncertainty about what to include in the plan when asthma control is deteriorating, but before the need for orally administered corticosteroids, is a contributing factor. The aim of this trial is to determine whether an asthma self-management plan, which includes a temporary quadrupling of the dose of inhaled corticosteroid when asthma control starts to deteriorate, reduces asthma exacerbations requiring orally administered corticosteroids or unscheduled health care consultation for asthma.METHODS: A multicentre, pragmatic, randomised trial in adults aged over 16 years with a clinical diagnosis of asthma, treated with a licensed dose of inhaled corticosteroid and at least one exacerbation in the previous 12 months requiring treatment with systemic corticosteroids. Participants will be randomised to either a self-management plan, which includes a temporary (maximum of 14 days) fourfold increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid. Participants will be followed up at 6 and 12 months and will attend the clinic for an additional visit if their asthma control deteriorates. The primary outcome is time to first asthma exacerbation, defined as the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. The estimated sample size is 1800 participants.DISCUSSION: The FAST trial is an independent study that has been prioritised and commissioned by the National Institute for Health Research (NIHR) in the United Kingdom. It will provide high-quality evidence to inform clinical decision-making on the role of an asthma self-management plan, which includes a temporary fourfold increase of inhaled corticosteroid, when asthma control starts to deteriorate. The first participant was randomised on 17th May 2013 and recruitment will close on 31 January 2016 with the last patient last visit taking place in January 2017.TRIAL REGISTRATION: ISRCTN: 15441965 , registered on 25 April 2013.

AB - BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan. There are a variety of reasons for this but uncertainty about what to include in the plan when asthma control is deteriorating, but before the need for orally administered corticosteroids, is a contributing factor. The aim of this trial is to determine whether an asthma self-management plan, which includes a temporary quadrupling of the dose of inhaled corticosteroid when asthma control starts to deteriorate, reduces asthma exacerbations requiring orally administered corticosteroids or unscheduled health care consultation for asthma.METHODS: A multicentre, pragmatic, randomised trial in adults aged over 16 years with a clinical diagnosis of asthma, treated with a licensed dose of inhaled corticosteroid and at least one exacerbation in the previous 12 months requiring treatment with systemic corticosteroids. Participants will be randomised to either a self-management plan, which includes a temporary (maximum of 14 days) fourfold increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid. Participants will be followed up at 6 and 12 months and will attend the clinic for an additional visit if their asthma control deteriorates. The primary outcome is time to first asthma exacerbation, defined as the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. The estimated sample size is 1800 participants.DISCUSSION: The FAST trial is an independent study that has been prioritised and commissioned by the National Institute for Health Research (NIHR) in the United Kingdom. It will provide high-quality evidence to inform clinical decision-making on the role of an asthma self-management plan, which includes a temporary fourfold increase of inhaled corticosteroid, when asthma control starts to deteriorate. The first participant was randomised on 17th May 2013 and recruitment will close on 31 January 2016 with the last patient last visit taking place in January 2017.TRIAL REGISTRATION: ISRCTN: 15441965 , registered on 25 April 2013.

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KW - exacerbation

KW - self-management plan

KW - inhaled corticosteroids

KW - oral corticosteroids Randomised controlled trial

KW - fourfold

KW - protocol

KW - primary care

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