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Quadrupling Inhaled Gluococorticoid Dose To Abort Asthma Exacerbations

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posted on 2018-02-12, 14:22 authored by Tricia McKeever, Kevin Mortimer, Andrew Wilson, Samantha Walker, Christopher Brightling, Andrew Skeggs, Ian Parvord, David Price, Lelia Duley, Mike Thomas, Lucy Bradshaw, Bernard Higgins, Bernard Haydock, Eleanor Mitchell, Graham Devereux, Timothy Harrison
Background Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a self-management plan, which included a temporary quadrupling of the dose of inhaled glucocorticoid when asthma control started to deteriorate, would reduce severe asthma exacerbations in adults with asthma. Methods A pragmatic, unmasked, randomized trial in adults with asthma, treated with inhaled glucocorticoids with or without additional add-on therapy and one or more exacerbation in the previous 12 months. We compared a self-management plan that included a four-fold increase in inhaled glucocorticoid dose with the same plan without an increase in glucocorticoid, over 12 months. The primary outcome was time to first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or unscheduled healthcare consultation for asthma. Results 1922 participants were randomized of whom 1871 contributed to the primary analysis. The number of participants having a severe asthma exacerbation in the year after randomization was 484 (51.6%) in the non-quadrupling group and 420 (45.0%) in the quadrupling group, with an adjusted hazard ratio for time to first severe exacerbation of 0.81 (95% confidence interval 0.71 to 0.92, p-value 0.002). Adverse effects, primarily related to local effects of inhaled glucocorticoids, were increased in the quadrupling group. Conclusion Severe exacerbations of asthma were reduced in adults with asthma with a personalized self-management plan that included a temporary four-fold increase in inhaled glucocorticoid dose when asthma control started to deteriorate.

Funding

Funded by NIHR Health Technology Assessment Programme; ClinicalTrials.gov, ISRCTN15441965

History

Citation

New England Journal of Medicine, 2018, 378, pp. 902-910

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Infection, Immunity and Inflammation

Version

  • AM (Accepted Manuscript)

Published in

New England Journal of Medicine

Publisher

Massachusetts Medical Society

issn

0028-4793

eissn

1533-4406

Acceptance date

2018-01-26

Copyright date

2018

Available date

2018-09-08

Publisher version

http://www.nejm.org/doi/full/10.1056/NEJMoa1714257

Notes

The file associated with this record is under embargo until 6 months after publication, in accordance with the publisher's self-archiving policy. The full text may be available through the publisher links provided above.

Language

en

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