Budesonide/formoterol turbuhaler vs pMDI salbutamol for acute asthma in outpatient emergency department: a prospective, randomized, open-label study.

Background: The Global Initiative for Asthma (GINA) has suggested the need for more studies on inhaled corticosteroid (ICS)-formoterol in the Emergency Department (ED).
Objectives: We aimed to compare the outcomes of budesonide/formoterol (160/4.5 mcg/inhalation) turbuhaler versus pressurized metered-dose inhaler (pMDI) salbutamol (100 mcg/puff) in acute asthma in the outpatient ED.
Methods: This single-centre, prospective, randomized, and open-label study involved adult asthma patients with mild to moderate asthma exacerbation who attended the outpatient ED of a tertiary hospital in Malaysia. The intervention arm received budesonide/formoterol (Symbicort ^® 160/4.5 mcg) turbuhaler, while the control arm received pMDI salbutamol with a valved holding chamber. Stratified randomization with variable baseline ICS use was employed. Direct discharge rate from outpatient ED was the primary outcome. Vital signs pre- and post-treatment between the two arms were also compared.
Results: Seventy-four ( n  = 37 for each arm) asthma patients were recruited. Baseline clinical characteristics were comparable between the two arms. Direct discharge rates from ED were comparable between the intervention (94.6%) and the control (91.9%) arms ( p  = 1.000). Post-treatment outcomes (respiratory rate, oxygen saturation, peak expiratory flow rate) were similar between the two arms, except for the higher increment of heart rate ( p  < 0.001) and lesser reduction of blood pressure in the control arm ( p  = 0.013). Intravenous hydrocortisone use was significantly higher in the control arm ( n  = 19, 51.4%) than in the budesonide/formoterol arm ( n  = 6, 16.2%) ( p  = 0.001).
Conclusion: Budesonide/formoterol turbuhaler is as effective as pMDI salbutamol in treating asthma exacerbation in the outpatient ED with less effect on heart rate and lower usage of intravenous corticosteroids.