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Asthma guidelines recommend adding a long-acting β-agonist (LABA) when asthma is not controlled with low-dose inhaled corticosteroids (ICS).* However, whether concomitant use of ICS mitigates the known risk for excess asthma-related deaths associated with LABA use is unclear (NEJM JW Gen Med Mar 1 2006 and Chest 2006; 129:15). The FDA asked manufacturers to conduct large studies to assess the safety of LABAs when used as an add-on therapy to ICS.
In this 26-week, industry-supported, randomized trial, researchers enrolled 11,693 adolescents and adults (age, ≥12) who had persistent asthma and one to four exacerbations in the previous year (but no previous life-threatening asthma events). Patients received twice-daily treatment with single inha…