In this RCT, 382 children aged 5-15 years with asthma using budesonide 50 μg-formoterol 3 μg, two actuations as needed, equivalent to 1 puff Symbicort 100/6 or Vannair 100/6, were compared to salbutamol 100 ug as needed.1
The primary outcome was asthma attacks as rate per participant per year.
The annualised rate of asthma attacks was lower in the budesonide-formoterol group than in the salbutamol group, cluster-adjusted rates 0·23 versus 0·41 per participant per year (relative rate 0·55 [95% CI 0·35-0·86]; p=0·012).
The number of participants with at least one adverse event was 162 (91%) in the budesonide-formoterol group and 167 (92%) in the salbutamol group.
Conclusion: In children aged 5-15 years with mild asthma, budesonide-formoterol reliever monotherapy is superior to salbutamol for preventing asthma attacks, with a similar safety profile.
