In an open-label trial among adults with mild asthma, budesonide-formoterol treatment was superior to albuterol for the prevention of asthma exacerbations.
Among adults with mild asthma, budesonide-formoterol therapy taken as needed was more effective at preventing exacerbations that albuterol as needed. Budesonide-formoterol used as needed did not differ significantly from budesonide maintenance therapy for this outcome.
Study authors Richard Beasley, DSc, Mark Holliday, BSc, Helen K. Reddel, PhD, et al, wrote that the open-label design of the Novel Symbicort Turbuhaler Asthma Reliever Therapy (Novel START) trial was “used to reflect clinical practice.”
Results from the Novel START trial were presented at the 2019 American Thoracic Society (ATS) International Conference in Dallas, TX.
The 52-week, open-label, controlled trial included 675 patients with mild asthma who were randomized to 1 of 3 groups: albuterol (100 μg, as needed for asthma symptoms); budesonide (200 μg, twice daily) plus as-needed albuterol; or budesonide—formoterol (200 μg of budesonide and 6 μg of formoterol, as needed). The analysis included data from 668 participants who were randomized.
The annualized exacerbation rate for the budesonide-formoterol group was lower than the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P <.001), but did not differ significantly from the budesonide maintenance group (absolute rate, 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = .65).
Additionally, the budesonide-formoterol group had fewer severe exacerbations (9) than either the albuterol group (23) or the budesonide maintenance group (21). The relative risk of severe exacerbations in the budesonide-formoterol group compared to the albuterol group was 0.40 (95% CI, 0.18 to 0.86) and compared to the budesonide maintenance group was 0.44 (95% CI, 0.20 to 0.96).
In an accompanying editorial, Gary W K Wong, MD, noted that the trial shows budesonide—formoterol taken as needed is suitable for patients with mild asthma as an alternative to budesonide maintenance therapy as it may reduce the risk of an exacerbation becoming severe enough to require urgent care.
“Both the SIENA trial and the Novel START trial showed that patients with mild asthma whose only asthma treatment was a SABA as needed for relief of asthma symptoms were at considerable risk for exacerbations,” wrote Wong. “Replacement of as-needed SABA treatment with as-needed budesonide—formoterol or inhaled glucocorticoid maintenance therapy could reduce such risk by approximately 50%.”
However, the study authors noted that maintenance treatment with budesonide was better able to control asthma symptoms.
At all visits, the Asthma Control Questionnaire—5 (ACQ-5) scores for the budesonide-formoterol group were lower than in the albuterol group (mean difference, −0.15; 95% CI, −0.24 to −0.06). However, ACQ-5 scores were higher in the budesonide-formoterol group compared to the budesonide maintenance group (mean difference, 0.14; 95% CI, 0.05 to 0.23).
“[F]or the patient for whom asthma symptoms rather than exacerbations are the most bothersome, maintenance treatment has value,” wrote Beasley, et al.
Wong added that these results should prompt a review of current guidelines for the treatment of mild asthma.
The study, “Controlled Trial of Budesonide—Formoterol as Needed for Mild Asthma,” and editorial, “How Should We Treat Patients with Mild Asthma?,” were published in the New England Journal of Medicine.