Combination Inhaled Corticosteroid and Short-acting Beta2 Agonist (ICS-SABA) Use for Older Adults With Asthma

The first combination inhaled corticosteroid and short-acting beta₂ agonist (ICS-SABA) was approved by the Food and Drug Administration (FDA) in 2023 for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma exacerbations in patients 18 years of age and older. The recently approved product contains an ICS-albuterol combination. The 2024 Global Initiative for Asthma (GINA) guidelines recommend as-needed ICS-formoterol as the preferred asthma reliever therapy; however, a GINA alternative recommendation is the use of ICS whenever an as-needed (SABA) is used. There is no difference in as-needed asthma treatment recommended by the GINA guidelines in older adults, and there has been minimal study in older adults. Because of limited guidance on the use of the ICS-SABA reliever inhaler in older adults, the purpose of this review is to evaluate the DENALI and MANDALA studies and the potential role of ICS-SABA in older adults. The mean ages in both studies were 50 years. The MANDALA primary outcome result was a statistically significant lower risk of severe exacerbations in the ICS-SABA reliever group compared with the as-needed albuterol (ALB) group at 24 weeks. In the MANDALA older adults subgroup analysis, there was not a statistically significant difference in the ICS-SABA reliever group compared with the as-needed ALB-alone group but the results favored ICS-SABA. The DENALI primary outcome results were a greater change from baseline in forced expiratory volume in the first second (FEV1) area under the curve averaged over 12 weeks with albuterol/budesonide (ALB-BUD) 180/160 ug compared with budesonide alone and placebo and a greater change from baseline in trough FEV1 with ALB-BUD 180/160 ug and 180/80 ug than ALB-alone and placebo. Because of minimal adverse effects in both trials and the benefits in preventing asthma exacerbations reported in the MANDALA trial, it is important to assess and recommend that older adults with asthma receive inhaled corticosteroid with their reliever asthma inhaler.