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Combination albuterol-budesonide rescue inhaler somewhat better than albuterol alone for preventing severe asthma exacerbations (MANDALA)
Clinical Question
Is a fixed-dose combination of albuterol and budesonide as a rescue medication more effective than albuterol alone in patients with moderate to severe asthma who are taking long-term inhaled corticosteroids?
Bottom line
A fixed-dose combination inhaler using a total dose of 180 mcg albuterol and 160 mcg budesonide as a rescue inhaler yielded a significant reduction in exacerbations and a reduction in the need for systemic corticosteroids. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (any)
Synopsis
These researchers identified participants 4 years and older with at least one severe asthma exacerbation (defined as hospitalization, an emergency department visit requiring systemic corticosteroids, or an exacerbation requiring at least 3 days of systemic corticosteroids) in the previous year. The 3132 patients were randomized to receive 1 of 3 types of rescue inhaler, each given as 2 actuations (doses shown are per actuation): (1) albuterol 90 mcg plus budesonide 80 mcg, (2) albuterol 90 mcg plus budesonide 40 mcg, or (3) albuterol 90 mcg. Children aged 4 to 11 were only randomized to receive the lower dose combination or albuterol only. Groups were balanced at baseline with a mean age of 49 years, and only 6% of participants were younger than 18 years. Analysis was by intention to treat, but allocation concealment was not described, either in this publication or in a previous publication describing the methods (BMJ Open Resp Res 2021;8:e001077). Patients were followed up for 24 weeks, with approximately 10% not completing the trial in each group. Patients in the higher-dose budesonide group had significantly fewer severe exacerbations than those in the albuterol-only group (hazard ratio [HR] 0.74; 95% CI 0.62 - 0.89). There were also fewer severe exacerbations in the low-dose budesonide group than in the albuterol-only group, but this difference was smaller and not statistically significant (HR 0.84; 0.71 - 1.0). The annualized rate of severe exacerbations was 0.43 in the high-dose budesonide group compared with 0.58 in the albuterol-only group, which is approximately one fewer severe exacerbation per year for every 7 patients treated. Patients in the high-dose combination group also took fewer systemic steroids (84 mg vs 130 mg per year).
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
Beta 2agonist works better in combination with steroid
Combination of budesonide with albuterol works much better than with albuterol alone HRAD patients
Albuterol
This is a Canadian publication, and there should be reference within this InfoPOEM, somewhere, that albuterol is equivalent to salbutamol, what we commonly use in Canada.
albuterol and budesonide combo
reduces asthma exacerbations