NEW YORK (Reuters Health) - Among patients with uncontrolled moderate to severe asthma, a fixed-dose combination of albuterol and budesonide gives better as-needed relief than albuterol alone, a large international study shows.
Over 24 weeks, the combination lowered the risk of severe exacerbation by 26% (P=0.001) when the doses were 180 ug of albuterol and 160 ug of budesonide. A 180 ug dose of albuterol was used in the control group.
The reduction was 16% (P=0.052) when 180 ug of albuterol was combined with 80 ug of budesonide, researchers report in the New England Journal of Medicine.
The 3,132 volunteers in the randomized trial had been taking a wide range of inhaled glucocorticoids as maintenance therapies and they continued using them throughout the study.
The findings show that the fixed-dose combination of an inhaled glucocorticoid and a fast-acting bronchodilator can be used as rescue therapy in addition to inhaled glucocorticoid-containing maintenance therapy.
"This is a simple strategy that improves the management of asthma," chief author Dr. Alberto Papi of the University of Ferrara Medical School, in Italy, told Reuters Health by phone.
"It's more effective without having to teach patients to do something different from what they're doing," he added.
"Both doses of albuterol-budesonide had an acceptable safety profile that was consistent with that of the active components, with no safety concerns identified," he and his colleagues write in their report.
The results of the MANDALA trial were also released Sunday at the American Thoracic Society's 2022 International Conference.
Dr. Papi said the study continued for more than 300 days and those results show that the benefit of the treatment "doesn't fade" over time.
The specific combination used in the study has not been approved in the United States.
However, current recommendations suggest using an inhaled glucocorticoid-containing rescue medication for as-needed treatment instead of short-acting beta-2-agonist rescue therapy, which carries risks.
"The data from this trial support that approach," the team writes.
The study included both children and adults. Children 4 to 11 years of age were randomly assigned to the lower-dose combination or to albuterol alone. The researchers did not assess growth indices in children because the number included in the test was small and the observation time short.
Nine patients in the higher-dose group ended up being hospitalized for at least one severe asthma exacerbation during the first 24 weeks versus 10 in the lower-dose group and 17 in the control group.
The rates of adverse events, including those leading to discontinuation of treatment, were similar in the three groups.
The test was sponsored by Avillion, which coordinated data management and statistical analyses. The treatment, also known as PT027, is being developed in conjunction with AstraZeneca.
SOURCE: https://bit.ly/3Mif8of The New England Journal of Medicine, online May 15, 2022.
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