Objectives <p>To compare the efficacy, safety and cost of Single Maintenance and Reliever Therapy (SMART) with low dose inhaled budesonide-formoterol combination vs. conventional budesonide plus as-needed levo-salbutamol, in 6-11-y-old children with asthma.</p> Methods <p>In this randomised controlled trial (RCT), 84 children (6–11 y) with treatment-naïve asthma were randomised to either SMART with inhaled budesonide-formoterol combination, or budesonide plus as-needed levo-salbutamol. Peak expiratory flow (PEF), asthma symptom score, number of rescue doses, exacerbations, adherence, inhalation technique, adverse events and cost were recorded over the first 12 wk of follow-up.</p> Results <p>Baseline PEF, asthma symptom score, and other characteristics were comparable. At the end of 12 wk, the median (IQR) improvement in PEF was 16% (10, 20) vs. 11% (8.5, 15.5), <i>p</i> = 0.01. The median (IQR) weekly asthma symptom score was 3 (2, 4.5) vs. 4 (3, 7), <i>p</i> = 0.02. The median (IQR) number of rescue doses were 0 (0, 0) vs. 4 (3, 6), <i>p</i> = 0.02. Only 9/37 (24.3%) vs. 16/37 (43.2%) children had exacerbations, <i>p</i> = 0.05. There were no adverse effects considered significant in either group. The total cost of treatment was lower with SMART.</p> Conclusions <p>SMART showed greater short-term efficacy and was less expensive compared to conventional therapy in 6–11 y-old asthmatic children, with no additional safety concerns.</p>