As-needed budesonide/formoterol similar to maintenance budesonide plus SABA in patients with mild asthma

Reference

Beasley R, Holliday M, Reddel HK, et al, for the Novel START Study Team. Controlled trial of budesonide-formoterol as needed for mild asthma. N Engl J Med 2019;380(21):2020-2030.

Synopsis

This study included patients with mild asthma who used a SABA alone at least twice in the previous 3 months, but no more than twice daily on average, and those who used a SABA alone and experienced a severe exacerbation in the past 12 months (7.3% of those enrolled). Which begs the question of why a patient who'd had a severe exacerbation (defined as requiring systemic corticosteroids or hospitalization) was being managed by a SABA alone. Patients hospitalized in the past 12 months were excluded. A total of 668 patients were randomized into 1 of 3 groups: (1) continued use of an as-needed SABA alone, (2) budesonide 200 mcg twice daily plus the SABA as needed, and (3) use of a combination inhaler containing 200 mcg budesonide and 6 mcg formoterol, one inhalation as needed to control symptoms. At baseline there were some imbalances, with fewer women in the as-needed SABA group (50.7% vs 55.5% to 57.3%), and, more important, more serious exacerbations in the past 12 months in the as-needed SABA group (20 vs 17 for budesonide maintenance and only 12 for the budesonide/formeterol group). Analysis was by intention to treat, and only 13 patients were lost to follow-up during the 1-year study. An exacerbation was defined as worsening symptoms requiring an urgent visit to a physician, prescription of a systemic corticosteroid, or heavy use of a SABA during a 24-hour period. The rate of exacerbations was significantly higher in the as-needed SABA group (0.4 per patient per year) compared with either budesonide/formeterol (0.195 per patient per year) or budesonide maintenance (0.175 per patient per year). So, for 100 patients there would be 40, 20, and 18 exacerbations per year, respectively (number needed to treat = 5 to prevent 1 exacerbation over 1 year). There were significantly fewer serious exacerbations in the as-needed budesonide/formeterol group (9) than in the maintenance budesonide (21) or as-needed SABA only (23) groups. However, the imbalance in severe exacerbations at baseline may have influenced this to some degree.