Risk for severe exacerbations significantly lower with as-needed fixed higher-dose combination treatment versus albuterol alone
TUESDAY, May 17, 2022 (HealthDay News) — For patients with moderate-to-severe asthma, as-needed use of a fixed combination of albuterol and budesonide is associated with a lower risk for severe asthma exacerbations compared with as-needed use of albuterol alone, according to a study published online May 15 in the New England Journal of Medicine to coincide with the American Thoracic Society 2022 International Conference, held from May 13 to 18 in San Francisco.
Alberto Papi, M.D., from the University of Ferrara Medical School in Italy, and colleagues conducted a multinational, phase 3 trial to examine the efficacy and safety of albuterol-budesonide compared to albuterol alone as rescue medication for patients with uncontrolled moderate-to-severe asthma receiving inhaled glucocorticoid-containing maintenance therapy. Participants (aged 12 years and older) were randomly assigned to a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide, a fixed-dose combination of 180 μg of albuterol and 80 μg of budesonide, or 180 μg of albuterol in a 1:1:1 ratio; children aged 4 to 11 years were randomly assigned to the lower-dose combination group or albuterol-only group.
A total of 3,132 patients underwent randomization; 97 percent were aged 12 years or older. The researchers found that the risk for severe asthma exacerbation was significantly lower in the higher-dose combination group than the albuterol-alone group (hazard ratio, 0.74; 95 percent confidence interval, 0.62 to 0.89; P = 0.001). The risk was also lower in the lower-dose combination group versus the albuterol-alone group (hazard ratio, 0.84; 95 percent confidence interval, 0.71 to 1.00; P = 0.052). The three trial groups had a similar incidence of adverse events.
“The annualized rate of severe asthma exacerbations was numerically lower with each albuterol-budesonide dose than with albuterol,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Avillion, which funded the study.
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