As-Needed Budesonide–Formoterol on Par with Maintenance Therapy for Mild Asthma

A 52-week, randomized, open-label, controlled trial revealed that budesonide–formoterol used as needed was superior to albuterol used as needed and on par with budesonide maintenance for the prevention of asthma exacerbations. A total of 675 patients were randomly assigned to the albuterol (100 μg as needed for asthma symptoms) group; budesonide (200 μg, twice daily) plus as-needed albuterol group; or budesonide–formoterol (200 μg of budesonide and 6 μg of formoterol as needed) group. The analysis included 668 patients. The annualized exacerbation rate in the budesonide–formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative risk, 0.49) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 vs. 0.175; relative risk, 1.12). The number of severe exacerbations was lower in the budesonide–formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44). However, maintenance treatment with budesonide was superior for control of asthma symptoms. The mean (±SD) dose of inhaled budesonide was 107±109 μg per day in the budesonide–formoterol group and 222±113 μg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use. The findings suggest that budesonide-formoterol used as needed is an acceptable alternative to maintenance budesonide maintenance therapy for patients with mild asthma. However, for the patient for whom asthma symptoms rather than exacerbations are the most bothersome, maintenance treatment has value. Source: https://www.nejm.org/