Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations

BACKGROUND Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deterio...

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Main Authors: McKeever, Tricia, Mortimer, Kevin, Wilson, Andrew, Walker, Samantha, Brightling, Christopher, Skeggs, Andrew, Pavord, Ian, Price, David, Duley, Lelia, Thomas, Mike, Bradshaw, Lucy, Higgins, Bernard, Haydock, Rebecca, Mitchell, Eleanor, Devereux, Graham, Harrison, Timothy
Format: Article
Language:English
Published: Massachusetts Medical Society 2018
Online Access:https://eprints.nottingham.ac.uk/50563/
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author McKeever, Tricia
Mortimer, Kevin
Wilson, Andrew
Walker, Samantha
Brightling, Christopher
Skeggs, Andrew
Pavord, Ian
Price, David
Duley, Lelia
Thomas, Mike
Bradshaw, Lucy
Higgins, Bernard
Haydock, Rebecca
Mitchell, Eleanor
Devereux, Graham
Harrison, Timothy
author_facet McKeever, Tricia
Mortimer, Kevin
Wilson, Andrew
Walker, Samantha
Brightling, Christopher
Skeggs, Andrew
Pavord, Ian
Price, David
Duley, Lelia
Thomas, Mike
Bradshaw, Lucy
Higgins, Bernard
Haydock, Rebecca
Mitchell, Eleanor
Devereux, Graham
Harrison, Timothy
author_sort McKeever, Tricia
building Nottingham Research Data Repository
collection Online Access
description BACKGROUND Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma. METHODS We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma. RESULTS A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group. CONCLUSIONS In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965.)
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spelling nottingham-505632018-09-08T04:30:16Z https://eprints.nottingham.ac.uk/50563/ Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations McKeever, Tricia Mortimer, Kevin Wilson, Andrew Walker, Samantha Brightling, Christopher Skeggs, Andrew Pavord, Ian Price, David Duley, Lelia Thomas, Mike Bradshaw, Lucy Higgins, Bernard Haydock, Rebecca Mitchell, Eleanor Devereux, Graham Harrison, Timothy BACKGROUND Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma. METHODS We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma. RESULTS A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group. CONCLUSIONS In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965.) Massachusetts Medical Society 2018-03-08 Article PeerReviewed application/pdf en https://eprints.nottingham.ac.uk/50563/1/Harrison.pdf McKeever, Tricia, Mortimer, Kevin, Wilson, Andrew, Walker, Samantha, Brightling, Christopher, Skeggs, Andrew, Pavord, Ian, Price, David, Duley, Lelia, Thomas, Mike, Bradshaw, Lucy, Higgins, Bernard, Haydock, Rebecca, Mitchell, Eleanor, Devereux, Graham and Harrison, Timothy (2018) Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations. New England Journal of Medicine, 378 (10). pp. 902-910. ISSN 1533-4406 http://www.nejm.org/doi/10.1056/NEJMoa1714257 doi:10.1056/NEJMoa1714257 doi:10.1056/NEJMoa1714257
spellingShingle McKeever, Tricia
Mortimer, Kevin
Wilson, Andrew
Walker, Samantha
Brightling, Christopher
Skeggs, Andrew
Pavord, Ian
Price, David
Duley, Lelia
Thomas, Mike
Bradshaw, Lucy
Higgins, Bernard
Haydock, Rebecca
Mitchell, Eleanor
Devereux, Graham
Harrison, Timothy
Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations
title Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations
title_full Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations
title_fullStr Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations
title_full_unstemmed Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations
title_short Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations
title_sort quadrupling inhaled glucocorticoid dose to abort asthma exacerbations
url https://eprints.nottingham.ac.uk/50563/
https://eprints.nottingham.ac.uk/50563/
https://eprints.nottingham.ac.uk/50563/