Maintenance inhaled corticosteroid therapy is effective for preventing severe asthma exacerbations in patients with mild to moderate asthma at baseline. However, adherence to these agents in clinical practice is poor. A proposed alternative approach is to use a combination of a long-acting beta-agonist (LABA), such as formoterol, and an inhaled corticosteroid, such as budesonide, as a reliever monotherapy, which would enable the titration of use according to symptom severity. In this open-label, randomized controlled trial, 885 patients with a self-reported doctor’s diagnosis of asthma who were using a short-acting beta-agonist (SABA) for symptom relief with or without low to moderate doses of inhaled corticosteroids in the previous 12 weeks were assigned to receive either reliever (as-needed) therapy with inhaled budesonide-formoterol, or maintenance budesonide plus as-needed terbutaline (a SABA), to assess the number of severe exacerbations per patient per year. A severe exacerbation was defined as the use of systemic corticosteroids for at least 3 days because of an asthma exacerbation, admission to hospital, or emergency department visit because of asthma requiring systemic corticosteroids. Patients were followed for 52 weeks. At baseline, 30% of patients were taking SABA reliever therapy alone, and 70% of patients were taking an inhaled corticosteroid in addition to a SABA. Researchers found that the rate of severe asthma exacerbations was lower with as-needed budesonide-formoterol than maintenance budesonide and as-needed terbutaline (RR 0.69, 95% CI 0.48 to 1.00, p=0.049). Furthermore, time to first severe exacerbation was longer with budesonide-formoterol than maintenance budesonide plus as-needed terbutaline. Nasopharyngitis was the most common adverse event in both groups, occurring in 35% of patients receiving as-needed budesonide-formoterol, and 32% of patients receiving maintenance budesonide plus terbutaline. This study was limited by its open-label design. These findings support the use of an as-needed corticosteroid-formoterol inhaler over maintenance therapy for the prevention of severe asthma exacerbations in patients with mild to moderate asthma.
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