title: Temperature-controlled laminar airflow in severe asthma for exacerbation reduction (The LASER Trial): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Asthma affects more than 5 million patients in the United Kingdom. Nearly 500,000 of these patients have severe asthma with severe symptoms and frequent exacerbations that are inadequately controlled with available treatments. The burden of severe asthma on the NHS is enormous, accounting for 80 % of the total asthma cost (£1 billion), with frequent exacerbations and expensive medications generating much of this cost. Of those patients with severe asthma, 70 % are sensitised to indoor aeroallergens, and the level of exposure to allergens determines the symptoms; patients exposed to high levels are therefore most at risk of exacerbations and hospital admissions. The LASER trial aims to assess whether a new treatment, temperature controlled laminar airflow (TLA) delivered by the Airsonett™ device, can reduce the frequency of exacerbations in patients with severe allergic asthma by reducing exposure to aeroallergens overnight.
  
  
  METHODS
  This multicentre study is a placebo-controlled, blinded, randomised controlled, parallel group trial. A total of 222 patients with a new or current diagnosis of severe allergic asthma will be assigned with a random element in a 1:1 ratio to receive either an active device for one year or a placebo device. The primary outcome is the frequency of severe asthma exacerbations occurring over a 12-month period, defined in accordance with the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Secondary outcomes include changes in asthma control, lung function, asthma-specific and global quality of life for participants and their carers, adherence to intervention, healthcare resource use and costs, and cost-effectiveness. Qualitative interviews will be conducted to elicit participant's and their partner's perceptions of the treatment.
  
  
  CONCLUSIONS
  Effective measures of allergen avoidance have, to date, proved elusive. The LASER trial aims to address this. The study will ascertain whether home-based nocturnal TLA usage over a 12-month period can reduce the frequency of exacerbations and improve asthma control and quality of life as compared to placebo, whilst being cost-effective and acceptable to adults with poorly controlled, severe allergic asthma. The results of this study will be widely applicable to the many patients with allergic asthma both in the UK and internationally.
  
  
  BACKGROUND
  Current controlled trials ISRCTN46346208 (Date assigned 22 January 2014).
authors.affiliation: Portsmouth Hospitals NHS Trust, Portsmouth, UK. william.storrar@porthosp.nhs.uk.
authors.forename: Will
authors.initials: W
authors.lastname: Storrar
authors.affiliation: Portsmouth Hospitals NHS Trust, Portsmouth, UK. carole.fogg@port.ac.uk.|University of Portsmouth, Portsmouth, UK. carole.fogg@port.ac.uk.
authors.forename: Carole
authors.initials: C
authors.lastname: Fogg
authors.affiliation: Portsmouth Hospitals NHS Trust, Portsmouth, UK. thomas.brown@porthosp.nhs.uk.
authors.forename: Tom
authors.initials: T
authors.lastname: Brown
authors.affiliation: University Hospital Southampton NHS Foundation Trust, Southampton, UK. paddy.dennison@uhs.nhs.uk.
authors.forename: Paddy
authors.initials: P
authors.lastname: Dennison
authors.affiliation: Centre for Statistics in Medicine, Oxford University, Oxford, UK. ly-mee.yu@phc.ox.ac.uk.
authors.forename: Ly-Mee
authors.initials: LM
authors.lastname: Yu
authors.affiliation: University of Portsmouth, Portsmouth, UK. ann.dewey@port.ac.uk.
authors.forename: Ann
authors.initials: A
authors.lastname: Dewey
authors.affiliation: Health Economics Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK. ramon.luengo-fernandez@dph.ox.ac.uk.
authors.forename: Ramon
authors.initials: R
authors.lastname: Luengo-Fernandez
authors.affiliation: University of Portsmouth, Portsmouth, UK. tara.dean@port.ac.uk.
authors.forename: Tara
authors.initials: T
authors.lastname: Dean
authors.affiliation: Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK. naj_rahman@yahoo.co.uk.
authors.forename: Najib
authors.initials: N
authors.lastname: Rahman
authors.affiliation: Heart of England NHS Foundation Trust, Birmingham, UK. adel.mansur@heartofengland.nhs.uk.
authors.forename: Adel
authors.initials: A
authors.lastname: Mansur
authors.affiliation: University Hospital Southampton NHS Foundation Trust, Southampton, UK. peter.howarth@uhs.nhs.uk.
authors.forename: Peter H
authors.initials: PH
authors.lastname: Howarth
authors.affiliation: University Hospitals of Leicester NHS Trust, Leicester, UK. pbradding@hotmail.com.
authors.forename: Peter
authors.initials: P
authors.lastname: Bradding
authors.affiliation: Portsmouth Hospitals NHS Trust, Portsmouth, UK. anoop.chauhan@porthosp.nhs.uk.
authors.forename: Anoop J
authors.initials: AJ
authors.lastname: Chauhan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000150:complications / Q000628:therapy*; D002985:Clinical Protocols; D004311:Double-Blind Method; D004780:Environment, Controlled; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D036301:Qualitative Research; D018401:Sample Size; D013696:Temperature