title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ISRCTN: 15441965 , registered on 25 April 2013.
authors.affiliation: Nottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Skeggs
authors.affiliation: Division of Epidemiology and Public Health, Clinical Sciences Building, University of Nottingham, Nottingham, NG5 1PB, UK.
authors.forename: Tricia
authors.initials: T
authors.lastname: McKeever
authors.affiliation: Nottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
authors.forename: Lelia
authors.initials: L
authors.lastname: Duley
authors.affiliation: Nottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Mitchell
authors.affiliation: Nottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Bradshaw
authors.affiliation: Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK.
authors.forename: Kevin
authors.initials: K
authors.lastname: Mortimer
authors.affiliation: Asthma UK, 18 Mansell Street, London, E1 8AA, UK.
authors.forename: Samantha
authors.initials: S
authors.lastname: Walker
authors.affiliation: Department of Health Sciences, Alcuin C Block, Alcuin College, University of York, York, Y010 5DD, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Parrott
authors.affiliation: Department of Health Sciences, University of Leicester, Leicester, LE1 6TP, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Wilson
authors.affiliation: NDM Research Building, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Pavord
authors.affiliation: Respiratory BRU, Glenfield Hospital, University of Leicester, Leicester, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Brightling
authors.affiliation: University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Chest Clinic C, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, UK.
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.affiliation: Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Aberdeen, AB25 2ZD, UK.
authors.forename: Graham
authors.initials: G
authors.lastname: Devereux
authors.affiliation: Respiratory Medicine, Cardiothoracic services, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, UK.
authors.forename: Bernard
authors.initials: B
authors.lastname: Higgins
authors.affiliation: Nottingham Respiratory Research Unit, Clinical Sciences Building, City Hospital Campus, University of Nottingham, Nottingham, NG5 1PB, UK. tim.harrison@nottingham.ac.uk.
authors.forename: Tim
authors.identifier: 0000-0002-0861-1901
authors.initials: T
authors.lastname: Harrison
authors.affiliation: Nottingham Clinical Trials Unit (NCTU), Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Haydock
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics*; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics*; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000503:physiopathology; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D016527:Drug Costs; D005260:Female; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D012107:Research Design; D012648:Self Care; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents
keywords: Asthma; Exacerbation; Fourfold; Inhaled corticosteroids; Oral corticosteroids Randomised controlled trial; Primary care; Protocol; Self-management plan