Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma

This study compared the efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) with salbutamol pressurized metered-dose inhaler (pMDI) with spacer for relief of acute bronchoconstriction in patients with asthma. In this randomized, double-blind, parallel-group study, patients (n=104 allocated to treatment; n=103 received treatment; mean age 45 years) seeking medical attention for acute asthma (mean FEV₁ 43% of predicted) received two doses repeated at t=-5 and 0 min of either budesonide/formoterol (320/9 μg, two inhalations) or salbutamol (100 μg×eight inhalations); total doses 1280/36μg and 1600 μg, respectively. All patients received prednisolone 60 mg at 90 min and FEV ₁ was assessed over 3 h. FEV₁ 90 min after dosing (primary variable) increased compared with pre-dose FEV₁ by an average of 30% and 32% for budesonide/formoterol and salbutamol, respectively (P=0.66), with similar increases at all timepoints from 3 to 180 min for both groups. Mean pulse rate over 3 h was significantly higher in the salbutamol group versus the budesonide/formoterol group (92 vs. 88 bpm; P<0.01). No treatment differences were seen for other vital signs, including ECG. High-dose budesonide/formoterol was effective and well tolerated for the treatment of acute asthma, with rapid onset of efficacy and a safety profile over 3 h similar to high-dose salbutamol.