Researchers from the Department of Respiratory Medicine of the University of Ferrara Medical School, in Ferrara, Italy found that an asthma rescue inhaler with a fixed-dose combination of albuterol and budesonide significantly lowered the risk of severe asthma exacerbations when compared to albuterol alone. Their findings were published in The New England Journal of Medicine.
The study’s lead author, Alberto Papi, wrote that the trial was motivated by the fact that the typical short-acting β2-agonist (SABA) rescue inhalers do not manage the worsening of inflammation, thereby increasing the risk of severe asthma exacerbations in patients who use these inhalers.
Albuterol With or Without Budesonide As Rescue Inhaler
The phase 3 trial enrolled 3,132 patients with uncontrolled moderate-to-severe asthma using a wide range of inhaled glucocorticoid-containing maintenance therapies, which they continued using throughout the study. The primary efficacy outcome was the first event of severe asthma exacerbation, based on a time-to-event analysis. The participants were randomized 1:1:1 between the rescue inhaler combinations:
- 180 μg of albuterol and 160 μg of budesonide via two actuations of 90 μg and 80 μg doses (higher-dose combination group)
- 180 μg of albuterol and 80 μg of budesonide via two actuations of 90 μg and 40 μg doses (lower-dose combination group)
- 180 μg of albuterol via two actuations of 90 μg doses (albuterol-alone group)
Reportedly, the risk of severe asthma exacerbation was 26% lower in the higher-dose combination group compared to the albuterol-alone group (hazard ratio [HR] 0.74; 95% CI, 0.62-0.89; P=.001). The lower-dose combination group was also advantaged compared to the albuterol-alone group with a HR of 0.84 (95% CI, 0.71-1.00; P=.052). Additionally, the incidence of adverse events was similar between the three trial groups, the authors noted.
The study’s authors ultimately concluded that as-needed use of 180 μg of albuterol and 160 μg of budesonide in a rescue inhaler appeared to significantly lower the risk of severe asthma exacerbations compared to the use of albuterol-alone alongside in patients with moderate-to-severe asthma.
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