When used as needed, the combination of budesonide-formoterol was found to be superior to albuterol for the prevention of asthma exacerbations in patients with mild asthma, according to a study presented at the American Thoracic Society 2019 meeting.

The 52-week open label trial (Novel Symbicort Turbuhaler Asthma Reliever Therapy [Novel START]) included 668 patients who were randomized to receive either albuterol 100µg (2 inhalations as needed), budesonide 200µg (1 inhalation twice daily) plus albuterol as needed (budesonide maintenance), or budesonide-formoterol 200/6µg (1 inhalation as needed); the primary endpoint of the study was annualized rate of asthma exacerbations.

Results showed that compared with the albuterol group, the rate of annual asthma exacerbations was lower in the budesonide-formoterol group (absolute rate 0.195 vs 0.400 per patient per year; relative rate: 0.49 [95% CI: 0.33-0.72; P <.001]); when compared with the budesonide maintenance group, no significant difference in exacerbation rate was observed (absolute rate 0.195 for budesonide–formoterol vs 0.175 for budesonide maintenance; relative rate: 1.12; 95% CI: 0.70-1.79; P =.65).

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The study findings also showed that there were fewer severe exacerbations (secondary endpoint; defined as worsening asthma leading to treatment with systemic glucocorticoids for ≥3 days or hospitalization/emergency department visit leading to systemic glucocorticoid treatment) in the budesonide-formoterol group (n=9)  than in the albuterol group (n=23) and budesonide maintenance group (n=21).


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“This clinical trial, in which an open-label design was used to reflect clinical practice, showed that budesonide–formoterol used as needed was superior to albuterol used as needed for the prevention of exacerbations in adults with mild asthma,” concluded the authors.

For more information visit nejm.org.