Adding budesonide may reduce exacerbations in mild asthma, industry trial finds
A manufacturer trial examined the efficacy and safety of adding budesonide to albuterol for as-needed therapy in patients ages 12 years and older with uncontrolled mild asthma despite treatment with a short-acting beta-agonist.
As-needed use of albuterol-budesonide resulted in lower risk of severe asthma exacerbations among patients whose condition was uncontrolled despite treatment for mild asthma, according to an industry-supported study.
To examine the efficacy and safety of adding budesonide to albuterol for as-needed therapy, researchers funded by AstraZeneca conducted a phase 3b, multicenter trial between September 2022 and August 2024. Patients ages 12 years and older with uncontrolled mild asthma despite treatment with a short-acting beta-agonist (SABA) with or without a low-dose inhaled glucocorticoid or leukotriene-receptor antagonist were included.
The trial randomly assigned patients to albuterol-budesonide (each dose equaling two inhaler actuations of 90 μg and 80 μg) or 180 μg of albuterol (each dose equaling two inhaler actuations of 90 μg) on an as-needed basis for up to 52 weeks. Participants were instructed to take no more than six doses in a 24-hour period. Results were published May 19 by the New England Journal of Medicine.
Of 2,516 patients, 1,797 (71.4%) completed the trial and 2,421 were included in the full analysis. Of the latter group, 1,209 were assigned to albuterol-budesonide, 1,212 were assigned to albuterol alone, and 74.4% used a SABA alone at baseline. In the on-treatment efficacy population analysis, 5.1% of those in the albuterol-budesonide group and 9.1% of those in the albuterol group had a severe exacerbation (hazard ratio [HR], 0.53; 95% CI, 0.39 to 0.73). These percentages were 5.3% and 9.4%, respectively, in the intention-to-treat population (HR, 0.54; 95% CI, 0.40 to 0.73) (P<0.001 for both comparisons). Both the annualized rate of severe asthma exacerbations (0.15 vs. 0.32; rate ratio, 0.47 [95% CI, 0.34 to 0.64]) and the mean annualized total dose of systemic glucocorticoids (23.2 vs. 61.9 mg per year) were lower with albuterol-budesonide than with albuterol. The two groups had similar adverse events.
The study authors noted that the significant drop in risk of a severe exacerbation with albuterol-budesonide led to the trial being stopped early after a planned interim analysis. “The results of a recent systematic review and meta-analysis of randomized trials in any type of asthma showed that rescue therapy with combination inhaled glucocorticoid-formoterol or inhaled glucocorticoid-SABA was associated with better asthma control and fewer exacerbations than a SABA only,” they wrote. “Together with the findings of the [this] trial, these results support the use of inhaled glucocorticoid-containing rescue therapy for persons treated for mild asthma.”