Clinical Question

Is as-needed use of a long-acting beta-agonist plus corticosteroid as effective as maintenance, low-dose corticosteroids in preventing severe exacerbations in patients with mild to moderate asthma?

Bottom Line

Patients with mild to moderate asthma only need relief treatment. In this study, patients taking the combination of budesonide/formoterol (Symbicort) as needed had slightly fewer severe exacerbations than patients treated with twice daily budesonide (Pulmicort). A recent POEM (https://www.essentialevidenceplus.com/content/poem/210808) reached similar conclusions. (Level of Evidence = 2b)

Synopsis

The researchers recruited adults with self-reported mild asthma who were taking only reliever therapy, either short-acting beta-agonists (SABAs) alone or SABAs plus low to moderate doses of inhaled corticosteroids, in the 12 weeks before randomization. They randomized patients (not concealed) to receive either relief therapy alone with one puff of budesonide 200 mcg/formoterol 6 mcg per inhalation (n = 437) or maintenance therapy with one puff twice daily of budesonide 200 mcg per inhalation (n = 447) and for rescue to use two puffs as needed for terbutaline 250 mcg per inhalation. Everyone except the statistician knew what interventions were assigned. The researchers evaluated the patients six times over a year. At baseline, the participants in each group were similar. Consistent with recruiting patients with mild asthma, the primary outcome, the number of exacerbations rarely occurred in either group. The researchers used standard criteria for determining if an exacerbation was severe: at least three days of systemic corticosteroids, or hospital admission or emergency department visit requiring systemic corticosteroids. Over the course of a year, the patients treated only as needed experienced fewer exacerbations (0.12 per year) compared with the maintenance-treated patients (0.17 per year). Although the difference was statistically significant, this does not look like an important difference. Roughly one-third of patients in each group also reported nasopharyngitis.

Study design: Randomized controlled trial (nonblinded)

Funding source: Government

Allocation: Unconcealed

Setting: Outpatient (any)

Reference: Hardy J, Baggott C, Fingleton J, et al.; PRACTICAL study team. Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial. Lancet. 2019;394(10202):919–928.