Ron Goldberg
In the MANDALA trial, albuterol-budesonide reduced exacerbations by 27% compared with albuterol alone, a reduction that may in part be due to better lung function.
As-needed albuterol-budesonide more effectively improves lung function in moderate-to-severe asthma than as-needed albuterol only, according to research presented at the American College of Chest Physicians 2023 Annual Meeting (CHEST 2023), held October 8 to 11, in Honolulu, Hawaii.
Investigators conducted a post hoc assessment reporting on lung function data from the phase 3 MANDALA study (ClinicalTrials.gov Identifier: NCT03769090), which compared treatment with as-needed albuterol-budesonide vs albuterol alone in patients with moderate to severe asthma.
The MANDALA study found that as-needed albuterol-budesonide 180/160 µg (the dose approved by the Food and Drug Administration [FDA]) vs albuterol alone was associated with a 27% reduction in severe exacerbations in patients at least 12 years of age on ICS-containing maintenance therapy who had at least 1 severe exacerbation in the past year. Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at 24 weeks was analyzed as an exploratory endpoint only.
In the post hoc analysis, investigators compared the proportions of patients taking albuterol-budesonide 180/160 µg vs albuterol alone who had FEV1 improvements over the 24-week period. Endpoints assessed included improvements in FEV1 of the following amounts: (1) at least 100 mL; (2) at least 150 mL; or (3) at least 12%.
The mean (SD) pre-bronchodilator FEV1 baseline was 2.0 (0.7) for both albuterol-budesonide 180/160 µg (n=1013) and for as-needed albuterol alone (n=1014).
From baseline to week-24, the estimated least square mean (LSM) (standard error [SE]) pre-bronchodilator FEV1 increase in the albuterol-budesonide 180/160 µg group was 134.3 (20.2) mL vs 74.0 (20.3) mL in the albuterol-only group (LSM difference, 60.3 mL; 95% CI, 27.8-92.8).
The investigators found that the percentages of patients in albuterol-budesonide 180/160 µg group vs the albuterol-only group meeting the 3 pre-bronchodilator FEV1 endpoints at week 24 were as follows: (1) FEV1 at least 100 mL: 46% vs 38%; (2) FEV1 at least 150 mL: 38% vs 31%; (3) FEV1 at least 12%: 29% vs 24%.
“Patients receiving as-needed albuterol-budesonide experience greater improvement in pre-bronchodilator FEV1 than those receiving as-needed albuterol,” the investigators concluded, adding that “the reduction in the risk of severe exacerbations observed in MANDALA with the albuterol-budesonide rescue inhaler may in part be due to improved lung function.”
Disclosure: This research was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
References:
Panettieri RA, Beasley R, Chipps BE, et al. Albuterol-budesonide as-needed rescue in patients with moderate-to-severe asthma improved lung function over 24 weeks vs albuterol alone in the MANDALA study. CHEST. 2023;164(4):A71-A74. doi:10.1016/j.chest.2023.07.101