Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations

McKeever, Tricia and Mortimer, Kevin and Wilson, Andrew and Walker, Samantha and Brightling, Christopher and Skeggs, Andrew and Pavord, Ian and Price, David and Duley, Lelia and Thomas, Mike and Bradshaw, Lucy and Higgins, Bernard and Haydock, Rebecca and Mitchell, Eleanor and 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

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Abstract

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.)

Item Type: Article
Additional Information: From The New England Journal of Medicine, Tricia McKeever, Ph.D., Kevin Mortimer, Ph.D., Andrew Wilson, M.D., Samantha Walker, Ph.D., Christopher Brightling, Ph.D., Andrew Skeggs, B.Sc., Ian Pavord, F.Med.Sci., David Price, F.R.C.G.P., Lelia Duley, M.D., Mike Thomas, Ph.D., Lucy Bradshaw, M.Sc., Bernard Higgins, Ph.D., Rebecca Haydock, B.Sc., Eleanor Mitchell, B.A., Graham Devereux, Ph.D., and Timothy Harrison, M.D., Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations, 378: 902-910. Copyright © 2018 Massachusetts Medical Society. Reprinted with permission.
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Epidemiology and Public Health
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Respiratory Medicine
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Identification Number: https://doi.org/10.1056/NEJMoa1714257
Depositing User: Claringburn, Tara
Date Deposited: 22 Mar 2018 08:26
Last Modified: 08 Sep 2018 04:30
URI: http://eprints.nottingham.ac.uk/id/eprint/50563

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