In adults with mild to moderate asthma, budesonide-formoterol used as needed for symptom relief was more effective in the prevention of severe exacerbations than maintenance low-dose budesonide plus as-needed terbutaline, according to the results of a multicenter randomized controlled trial (Australian New Zealand Clinical Trials Registry ID: ACTRN12616000377437) published in Lancet.
A combination of an inhaled corticosteroid with a fast-onset long-acting β-agonist used as reliever monotherapy reduces severe exacerbations by more than half compared with short-acting β-agonist (SABA) reliever alone. However, there is uncertainty about the relative efficacy and safety of this regimen compared with maintenance inhaled corticosteroid plus as-needed SABA.
Therefore, researchers in New Zealand conducted the first independently-funded open-label study comparing inhaled corticosteroid-formoterol reliever therapy with maintenance inhaled corticosteroid plus SABA reliever therapy in adults with mild to moderate asthma in a real-world setting.
In this 52-week study, 437 patients received reliever therapy with budesonide 200 μg formoterol 6 μg Turbuhaler (1 inhalation as needed for relief of symptoms) and 448 patients received maintenance budesonide 200 μg Turbuhaler (1 inhalation twice daily) plus terbutaline 250 μg Turbuhaler (2 inhalations as needed). They found that budesonide-formoterol reliever therapy resulted in fewer severe exacerbations (absolute rate per patient per year, 0.119 vs 0.172; relative rate, 0.69; 95% CI, 0.48-1.00; P =.049) and patients on this therapy had a longer time to first severe exacerbation compared with patients on maintenance budesonide plus as-needed terbutaline. Nasopharyngitis was the most common adverse event reported in both groups.
“In adults with mild to moderate asthma, budesonide-formoterol used as needed for symptom relief was more effective at preventing severe exacerbations than maintenance low-dose budesonide plus as-needed terbutaline,” the investigators concluded. “The findings support the 2019 Global Initiative for Asthma recommendation that inhaled corticosteroid-formoterol reliever therapy is an alternative regimen to daily low-dose inhaled corticosteroid for patients with mild asthma.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Hardy J, Baggott C, Fingleton J, et al; on behalf of the PRACTICAL study team. Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial. Lancet 2019;394(10202):919-928.