Abstract
BackgroundAsthma 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.MethodsThis 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.DiscussionEffective 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.Trial registrationCurrent controlled trials ISRCTN46346208 (Date assigned 22 January 2014).
Highlights
Asthma affects more than 5 million patients in the United Kingdom
Asthma affects over 5.4 million people in the United Kingdom, with nearly 500,000 experiencing severe symptoms and frequent exacerbations that are inadequately controlled with available treatments [1, 2]
Methods of allergen avoidance have lacked the necessary evidence to support their widespread implementation despite broncho-provocation experiments demonstrating that aeroallergens can induce bronchospasm, eosinophilic airway inflammation, and increased bronchial hyper-reactivity in sensitised patients
Summary
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 most at risk of exacerbations and hospital admissions. Asthma affects over 5.4 million people in the United Kingdom, with nearly 500,000 experiencing severe symptoms and frequent exacerbations that are inadequately controlled with available treatments [1, 2]. The 2011 British Thoracic Society (BTS) and Scottish Intercollegiate Guidelines Network (SIGN) national asthma guidelines [7] and 2010 WHO consultation on severe asthma [8] have highlighted an urgent need for research in severe asthma, acknowledging the limitations of available treatments in severe asthma and the dearth of clinical trials upon which to base management recommendations
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