Budesonide/Formoterol Maintenance Plus Reliever Therapy: A New Strategy in Pediatric Asthma

Objectives A fixed combination of long-acting β 2 -agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca RD Lund, Sweden] could reduce exacerbations. Methods Patients received SMART (budesonide/formoterol 80/4.5 μg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 μg qd for maintenance (fixed combination), or higher-dose budesonide 320 μg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 μg) was provided in both fixed-dose groups. Results SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p Conclusion The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.