Severe Asthma Exacerbation Risk Reduced with Combined Albuterol-Budesonide

New data published in the New England Journal of Medicine indicated that an as-needed, fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide resulted in significantly lower risk of severe asthma exacerbation than abluterol alone in patients with uncontrolled moderate to severe asthma who were receiving a variety of inhaled glucocorticoid-containing maintenance therapies.

The results were also presented at with the American Thoracic Society 2022 International Conference in San Francisco.

Traditionally, short-acting β2-agonist (SABA) rescue therapy will be utilized in patients whose asthma symptoms worsen. However, SABAs are not intended for addressing worsening inflammation.

Research has indicated that a fixed-dose combination of albuterol and budesonide would reduce the risk of severe asthma exacerbation when compared to albuterol alone.

Alberto Papi, MD, from the Department of Respiratory Medicine at the University of Ferrara Medical School in Italy, led a team of investigators in conducting a multinational, double-blind, phase 3 trial that evaluated the efficacy and safety of albuterol-budesonide as a rescue medication.

The investigative team enrolled adults and adolescents 12 years and older with uncontrolled moderate to severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies at the time. These therapies were continued during the trial.

Eligible patients were randomized 1:1:1 to 1 of 3 trial groups including a fixed-dose combination of albuterol at a dose of 180 μg and budesonide at a dose of 160 μg, a fixed-dose combination of albuterol at a dose of 180 μg and budesonide at a dose of 80 μg, or albuterol at a dose of 180 μg.

Notably, children 4 to 11 years were randomly assigned to either the lower-dose combination groups or the albuterol-only group. Among the 3132 patients included in thr trial, 97% were 12 years or older.

Papi and colleagues defined the primary endpoint as the first severe asthma exacerbation in a time-to-event analysis.

The team observed that severe asthma exacerbation was significantly lower in the higher-dose combination group, specifically by 26%, when compared to the albuterol-alone group (hazard ratio, 0.74, 95% confidence interval). (P=0.001).

Compared to the albuterol-only group, the hazard ratio in the lower-dose combination group was 0.84 (95% CI, 0.71 to 1.00) (P=0.052), and the incidence of adverse events were similar across all trial groups.