Fewer severe exacerbations in pts with mild-mod asthma txed with prn budesonide + formoterol than maintenance budesonide

Reference

Hardy J, Baggott C, Fingleton J, et al. 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.

Synopsis

These researchers recruited adults with self-reported mild asthma who were taking only reliever therapy, either short-acting beta agonists (SABAs) alone or SABA 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/inhalation (n=437) or maintenance therapy with one puff twice daily of budesonide 200 mcg/inhalation (n=447) and for rescue to use two puffs as needed for terbutaline 250 mcg/inhalation. Everybody 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 3 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). While the difference was statistically significant, this really does not look like an important difference. Roughly 1/3 of patients in each group also reported nasopharyngitis.