posted on 2018-02-12, 14:22authored byTricia 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
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