Compared with albuterol alone, a fixed-dose combination of albuterol and budesonide may help to serve as a rescue therapy for patients with uncontrolled moderate-to-severe asthma, according to recent research in The New England Journal of Medicine.
Alberto Papi, MD, of the University of Ferrara Medical School, Italy, and colleagues evaluated 3,132 patients with moderate-to-severe asthma in the phase 3 MANDALA trial who received either albuterol alone or albuterol with budesonide as rescue medication in addition to their existing inhaled glucocorticoid-containing maintenance therapies.
The dosing was two actuations of albuterol at 90 μg and budesonide at 80 μg in a higher-dose combination group, two actuations of albuterol at 90 μg and budesonide at 40 μg in a lower-dose combination group, or two actuations of albuterol at 90 μg in the group that received albuterol alone. Nearly all patients (97%) were at least 12 years or older, but children 11 years old or younger were randomized to either the lower-dose albuterol and budesonide group or the group that received albuterol alone. The researchers assessed time to first severe asthma exacerbation as a primary outcome.
Compared with the group that received albuterol alone, Papi and colleagues found a significantly lower risk of severe exacerbation among patients in the higher-dose combination group (HR = 0.74; 95% CI, 0.62-0.89; P = .001). There was also a lower risk of severe exacerbation in the group that received a lower-dose combination of albuterol and budesonide compared with albuterol, but the risk was not statistically significant (HR = 0.84; 95% CI, 0.71-1; P = .052).
“The finding of a mean number of medication doses per day of less than 1.5 across the three trial groups shows that the patients used the albuterol-budesonide combination as they used albuterol alone,” the researchers said. Adverse event rates in the higher-dose combination (46.2%), lower-dose combination (47.1%), and albuterol alone (46.4%) groups were similar, and no group had a significantly higher rate of serious adverse events.
“Given the risks and limitations of SABA alone as rescue therapy, national and international recommendations call for an inhaled glucocorticoid-containing rescue medication as the preferred as-needed treatment; the data from this trial support that approach,” the researchers concluded. “Given its acceptable safety profile, the greater efficacy of the fixed-dose combination than of albuterol alone, as well as the absence of a need to change underlying maintenance therapy, indicates that this fixed-dose combination could replace SABA alone as rescue therapy in patients with moderate-to-severe asthma.”
Disclosures: Authors declared financial ties to drugmakers. See full study for details. MANDALA was supported by Avillion.
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