OBJECTIVE Combination therapy with inhaled corticosteroids and long-acting β(2)-agonists results in improved asthma symptom control compared with the use of inhaled corticosteroids alone. However, the effects of combination therapy on structural changes and inflammation of the airways are still unknown. The aim of this study was to compare the effects of budesonide/formoterol with those of budesonide alone on airway dimensions and inflammation in individuals with asthma. METHODS Fifty asthmatic patients were randomized to treatment with budesonide/formoterol (200/6 µg, two inhalations bd) or budesonide (200 µg, two inhalations bd) for 24 weeks. Airway dimensions were assessed using a validated computed tomography technique, and airway wall area (WA) corrected for body surface area (BSA), percentage WA (WA%), wall thickness/Ösquare root BSA, and luminal area (Ai)/BSA at the right apical segmental bronchus, were measured. The percentage of eosinophils in induced sputum, pulmonary function, and Asthma Quality of Life Questionnaires (AQLQ) were also evaluated. RESULTS There were significantly greater decreases in WA/BSA (P < 0.05), WA% (P < 0.001) and wall thickness/square root BSA (P < 0.05), and increases in Ai/BSA (P < 0.05), in subjects treated with budesonide/formoterol compared with those treated with budesonide. The reduction in sputum eosinophils and increase in per cent of predicted forced expiratory volume in 1 s (FEV(1) %) were greater for subjects treated with budesonide/formoterol compared with those treated with budesonide alone. In the budesonide/formoterol group, the changes in WA% were significantly correlated with changes in sputum eosinophils and FEV(1%) (r = 0.84 and r = 0.64, respectively). There were improvements in the AQLQ scores after treatment with budesonide/formoterol. CONCLUSIONS Budesonide/formoterol combination therapy is more effective than budesonide alone for reducing airway wall thickness and inflammation in individuals with asthma.