Objectives: A fixed combination of long-acting 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 R&D; Lund, Sweden] could reduce exacerbations.
Methods: Patients received SMART (budesonide/formoterol 80/4.5 g qd maintenance plus
additional inhalations for symptom relief), budesonide/formoterol 80/4.5 g qd for maintenance
(fixed combination), or higher-dose budesonide 320 g qd (fixed-dose budesonide). Blinded
as-needed medication (terbutaline 0.4 g) was provided in both fixed-dose groups.
Results: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p0.02) and
fixed-dose combination (p<0.001). Rates of exacerbation requiring medical intervention were reduced
by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs
0.28/patient and 0.40/patient, respectively; both p<0.001). Mild exacerbation days and awakenings were
significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p<0.01).
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. (CHEST 2006; 130:1733–1743)
Key words: asthma; budesonide/formoterol; inhaled corticosteroids; long-acting 2-agonist; pediatric; Symbicort
Abbreviations: ACTHadrenocorticotrophic hormone; AEadverse events; ANOVAanalysis of variance;EDemergency
department; ICSinhaled corticosteroids; LABAlong-acting 2-agonists; PEFpeak expiratory flow; SMARTSymbicort
maintenance and relief therapy
Bisgaard et. al. (Chest, 2008) Budesonide-Formoterol Maintenance Plus Reliever Therapy, a New Strategy in Pediatric Asthma (1).pdf
