Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations

Autor: Kevin Mortimer, Mike Thomas, Graham Devereux, Timothy Harrison, Christopher E. Brightling, David Price, Andrew Wilson, Eleanor J Mitchell, Lucy Bradshaw, Samantha Walker, Rebecca Haydock, Andrew Skeggs, Tricia McKeever, Ian D. Pavord, Lelia Duley, Bernard Higgins
Rok vydání: 2018
Předmět:
Zdroj: New England Journal of Medicine. 378:902-910
ISSN: 1533-4406
0028-4793
DOI: 10.1056/nejmoa1714257
Popis: BACKGROUND: \ud 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.\ud \ud METHODS: \ud 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.\ud \ud RESULTS: \ud 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.\ud \ud CONCLUSIONS: \ud 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 .).
Databáze: OpenAIRE