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temperature-controlled laminar airflow in severe asthmas for exacerbation reduction (The LASER Trial)

temperature-controlled laminar airflow in severe asthmas for exacerbation reduction (The LASER Trial)
temperature-controlled laminar airflow in severe asthmas for exacerbation reduction (The LASER Trial)
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.

Discussion: 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.

Trial registration: Current controlled trials ISRCTN46346208 (Date assigned 22 January 2014).
severe asthma, temperature-controlled laminar airflow, exacerbation, quality of life, cost effectiveness
1745-6215
1-13
Storrar, W.
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Fogg, C.
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Brown, T.
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Dennison, P.
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Yu, L.M.
20720262-6da0-4ff6-83a8-f57a4c1f42ce
Dewey, A.
67204ad1-2779-4fd1-9fb7-fb3ac2b3df30
Luengo-Fernandez, R.
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Dean, T.
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Rahman, N.
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Mansur, A.
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Howarth, P.H.
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Bradding, P.
39990c99-3c21-44b6-b1f7-084eddf29722
Chauhan, A.J.
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Storrar, W.
7c28dada-1c5a-4452-9c60-5ffb2c8b3959
Fogg, C.
42057537-d443-462a-8944-c804252c973b
Brown, T.
65b220ab-5839-4e03-b923-97694339baaf
Dennison, P.
30c232e3-c218-4dd8-979f-061ac70513d5
Yu, L.M.
20720262-6da0-4ff6-83a8-f57a4c1f42ce
Dewey, A.
67204ad1-2779-4fd1-9fb7-fb3ac2b3df30
Luengo-Fernandez, R.
b89c81ad-df36-4315-9c16-9dcf5b207230
Dean, T.
4a68a12c-bf67-4157-87c9-71e1ea6c94db
Rahman, N.
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Mansur, A.
8874e7d7-d350-4081-8fb5-fe54de66a0dd
Howarth, P.H.
ff19c8c4-86b0-4a88-8f76-b3d87f142a21
Bradding, P.
39990c99-3c21-44b6-b1f7-084eddf29722
Chauhan, A.J.
80ced09a-aebc-4540-82f1-eef6cb8e7f2d

Storrar, W., Fogg, C., Brown, T., Dennison, P., Yu, L.M., Dewey, A., Luengo-Fernandez, R., Dean, T., Rahman, N., Mansur, A., Howarth, P.H., Bradding, P. and Chauhan, A.J. (2016) temperature-controlled laminar airflow in severe asthmas for exacerbation reduction (The LASER Trial). Trials, 17 (15), 1-13. (doi:10.1186/s13063-015-1134-y). (PMID:26743812)

Record type: Article

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.

Discussion: 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.

Trial registration: Current controlled trials ISRCTN46346208 (Date assigned 22 January 2014).

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Accepted/In Press date: 18 December 2015
Published date: 8 January 2016
Keywords: severe asthma, temperature-controlled laminar airflow, exacerbation, quality of life, cost effectiveness
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 390332
URI: https://eprints.soton.ac.uk/id/eprint/390332
ISSN: 1745-6215
PURE UUID: a8862f39-34bc-4130-a8fa-73e12048cf77

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Date deposited: 24 Mar 2016 11:15
Last modified: 02 Dec 2019 20:19

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Contributors

Author: W. Storrar
Author: C. Fogg
Author: T. Brown
Author: P. Dennison
Author: L.M. Yu
Author: A. Dewey
Author: R. Luengo-Fernandez
Author: T. Dean
Author: N. Rahman
Author: A. Mansur
Author: P.H. Howarth
Author: P. Bradding
Author: A.J. Chauhan

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