As-Needed Inhaled Steroids Plus Long-acting Bronchodilators for Mild Asthma

June 19, 2018

Information sourced from NEJM Journal Watch:


As-Needed Inhaled Steroids plus Long-Acting Bronchodilators for Mild Asthma


This combination was as effective as daily inhaled steroids for preventing exacerbation.


Current asthma guidelines recommend daily low-dose inhaled steroids for patients with mild persistent asthma, but patients with minimal symptoms can be reluctant to use daily medications. In two new blinded, industry-sponsored studies, researchers compared as-needed therapies with maintenance therapies.


In the first trial, 3849 adolescent and adult patients with mild asthma were randomized to one of three groups: (1) as-needed terbutaline (an inhaled, dry-powder, short-acting β-agonist used in Europe) with no daily controller, (2) as-needed budesonide/formoterol, (a fixed combination of an inhaled steroid [ICS] plus a fast-acting long-acting β-agonist [LABA]) with no daily controller, or (3) daily budesonide plus rescue terbutaline. Patients were followed for 1 year with daily medication reminders and frequent visits. For the primary endpoint of asthma control, as-needed budesonide/formoterol was superior to as-needed terbutaline but was inferior to daily budesonide plus rescue terbutaline. The rates of severe exacerbations that required systemic corticosteroids were similar in the as-needed–budesonide/formoterol and daily-budesonide groups (0.07 and 0.09 exacerbations annually), but the as-needed group used only 17% as much ICS as did the daily group. Both budesonide therapies were superior to as-needed terbutaline (0.2 exacerbations annually).


In the second trial, 4215 asthma patients were randomized to as-needed budesonide/formoterol only or to daily budesonide with rescue terbutaline. Patients were followed for 1 year with no medication reminders and occasional visits. The primary endpoint of severe exacerbations was similar in the two groups (0.11 and 0.12 annually), but the daily-budesonide group had modestly improved symptom control at the expense of a 75% higher mean daily ICS dose.




Although as many as three quarters of asthma patients are deemed to have mild asthma, the term “mild” is misleading, because these patients account for one third of all severe exacerbations. For patients in whom symptom control is the main concern and among those with moderate-to-severe asthma, daily ICS is the best option; for patients with mild intermittent asthma, a short-acting β-agonist is sufficient. But for patients with mild persistent asthma who would rather not use daily medication but still need protection from exacerbations, as-needed budesonide/formoterol is an attractive option. An editorialist estimates that, if mild asthmatic patients in the U.S. did not use expensive daily ICS inhalers, asthma medication costs would be lowered by US$1 billion annually; however, this approach is not FDA approved, and, in the U.S., we have only a metered-dose inhaler version of budesonide/formoterol (Symbicort) instead of the dry-powder device used in these studies.


David J. Amrol, MD reviewing Bateman ED et al. N Engl J Med 2018 May 17.




Bateman ED et al. As-needed budesonide–formoterol versus maintenance budesonide in mild asthma. N Engl J Med 2018 May 17; 378:1877.


Lazarus SC. On-demand versus maintenance inhaled treatment in mild asthma. N Engl J Med 2018 May 17; 378:1940.


O’Byrne PM et al. Inhaled combined budesonide–formoterol as needed in mild asthma. N Engl J Med 2018 May 17; 378:1865.


NEJM Journal Watch is produced by NEJM Group, a division of the Massachusetts Medical Society. Copyright ©2018 Massachusetts Medical Society. All rights reserved.


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Curt Wood, R.Ph., FASCP

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