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 (R) Turbuhalere (R)) 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 mu g, two inhalations) or salbutamol (100 mu g x eight inhalations); total doses 1280/36 mu g and 1600 mu g, respectively. All patients received prednisolone 60 mg at 90 min and FEV1 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. (c) 2005 Elsevier Ltd. All rights reserved.