Evidence map›Paper›PMID 27737713›Full record

Trial reportTrials2016

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 and 7 more

Abstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Andrew SkeggsNottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Tricia McKeeverDivision of Epidemiology and Public Health, Clinical Sciences Building, University of Nottingham, Nottingham, NG5 1PB, UK.
Lelia DuleyNottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Eleanor MitchellNottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Lucy BradshawNottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Kevin MortimerLiverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK.
Samantha WalkerAsthma UK, 18 Mansell Street, London, E1 8AA, UK.
Steve ParrottDepartment of Health Sciences, Alcuin C Block, Alcuin College, University of York, York, Y010 5DD, UK.
Andrew WilsonDepartment of Health Sciences, University of Leicester, Leicester, LE1 6TP, UK.
Ian PavordNDM Research Building, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK.
Chris BrightlingRespiratory BRU, Glenfield Hospital, University of Leicester, Leicester, UK.
Mike ThomasUniversity of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
David PriceChest Clinic C, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, UK.
Graham DevereuxCentre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Aberdeen, AB25 2ZD, UK.
Bernard HigginsRespiratory Medicine, Cardiothoracic services, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, UK.
Tim HarrisonNottingham Respiratory Research Unit, Clinical Sciences Building, City Hospital Campus, University of Nottingham, Nottingham, NG5 1PB, UK. tim.harrison@nottingham.ac.uk.ORCID 0000-0002-0861-1901
Rebecca HaydockNottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.

Funding

Department of Health 10/143/01
6 · The paper itself

Abstract

backgroundAsthma 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.

methodsA 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 registrationISRCTN: 15441965 , registered on 25 April 2013.

Indexed as

Drug CostsAdministration, InhalationAdministration, OralAdolescentAdrenal Cortex HormonesAdultAnti-Asthmatic AgentsAsthmaClinical ProtocolsCost-Benefit AnalysisDisease ProgressionFemaleHumansLungMaleResearch DesignAdrenal Cortex HormonesAnti-Asthmatic AgentsAsthmaExacerbationFourfoldInhaled corticosteroidsOral corticosteroids Randomised controlled trialPrimary careProtocolSelf-management plan

Identifiers

PMID27737713
PMCPMC5064792

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.