Quick Take: Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL)

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.

Click to read the study in Lancet

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