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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.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.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.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 .).

Original publication




Journal article


The New England journal of medicine

Publication Date





902 - 910


From the Department of Epidemiology and Public Health (T.M.) and the Nottingham Respiratory Research Unit (T.H.), National Institute for Health Research (NIHR) Biomedical Research Centre, and the Nottingham Clinical Trials Unit (A.S., L.D., L.B., R.H., E.M.), University of Nottingham, Nottingham, the Liverpool School of Tropical Medicine and Aintree University Hospital, Liverpool (K.M.), the University of Leicester (A.W.) and the Leicester NIHR Biomedical Research Centre, University of Leicester (C.B.), Leicester, Asthma UK, London (S.W.), the Respiratory Medicine Unit and Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford (I.P.), the Centre of Academic Primary Care (D.P.) and the Institute of Medical Sciences (G.D.), University of Aberdeen, Aberdeen, the Primary Care and Population Science and NIHR Southampton Biomedical Research Centre, University of Southampton, Southampton (M.T.), and the Department of Respiratory Medicine, Newcastle upon Tyne Hospitals NHS Trust, Newcastle upon Tyne (B.H.) - all in the United Kingdom.


Humans, Asthma, Anti-Asthmatic Agents, Administration, Inhalation, Proportional Hazards Models, Dose-Response Relationship, Drug, Adolescent, Adult, Female, Male, Kaplan-Meier Estimate, Fluticasone, Self-Management