Budesonide-formoterol reliever therapy vs maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): A 52-week, open-label, multicentre, superiority, randomized controlled trial
The Lancet Aug 29, 2019
Hardy J, Baggott C, Fingleton J, et al. - Via a 52-week, open-label, parallel-group, multicenter, superiority, randomized, controlled trial that was conducted at 15 primary care or hospital-based clinical trials units and primary care practices in New Zealand, researchers examined the efficiency of combination budesonide–formoterol reliever therapy in contrast with maintenance budesonide plus as-needed terbutaline. A total of 885 participants were randomized to either budesonide–formoterol as needed (n = 437) or budesonide maintenance plus terbutaline as needed (n = 448). Severe aggravations per patient per year were lower with as-needed budesonide–formoterol vs maintenance budesonide plus terbutaline as needed. The most prevalent adverse event in both groups was nasopharyngitis occurring in 154 patients receiving as-needed budesonide–formoterol and 144 receiving maintenance budesonide plus terbutaline as needed. In all, budesonide–formoterol used as needed for symptom relief was more efficient at preventing severe aggravations vs maintenance low-dose budesonide plus as-needed terbutaline. Moreover, for patients with mild asthma, findings supported the 2019 Global Initiative for Asthma recommendation that inhaled corticosteroid–formoterol reliever therapy is an alternative regimen to daily low-dose inhaled corticosteroid.
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