Budesonide–formoterol reliever combo superior to salbutamol alone for mild asthma in kids

The combination of inhaled corticosteroid budesonide plus formoterol appears to work better than the short-acting β₂-agonist (SABA) salbutamol alone as reliever monotherapy for mild asthma in children, being associated with lower incidence of asthma attacks in a randomized controlled trial (RCT).

The open-label, parallel-group, multicentre, superiority RCT included 360 children ages 5–15 years who were using SABA reliever monotherapy for mild asthma. These participants were randomly assigned to receive either budesonide 50 μg–formoterol 3 μg, two actuations as needed (n=179) or salbutamol 100 μg, two actuations as needed (n=181) for 52 weeks.

Asthma attacks, the primary outcome, were calculated as rate per participant per year.

Results showed that the annualized rate of asthma attacks was significantly reduced with the budesonide–formoterol combination than with salbutamol alone. The corresponding cluster-adjusted rates were 0.23 vs 0.41 per participant per year (relative rate, 0.55, 95 percent confidence interval [CI], 0.35–0.86; p=0.012).

The percentage of participants who experienced at least one adverse event was 162 (91 percent) in the budesonide–formoterol group and 167 (92 percent) in the salbutamol alone group (odds ratio, 0.79, 95 percent CI, 0.35–1.79).

The findings demonstrate the superiority of budesonide–formoterol reliever monotherapy over salbutamol alone for preventing asthma attacks in children with mild asthma, while having a similar safety profile.