As-Needed Budesonide Plus Albuterol Is Superior to Albuterol Alone for Poorly Controlled Mild Asthma

In people 12 years and older with poorly controlled mild asthma, is as-needed use of a fixed-dose combination of budesonide and albuterol superior to albuterol alone?

For patients with mild but poorly controlled asthma, the use of a combination rescue inhaler (albuterol plus budesonide) resulted in fewer exacerbations than albuterol alone. (Level of Evidence = 1b)

The study included 2,516 participants 12 years and older; at baseline, 74% were taking a short-acting beta2 agonist (SABA), such as albuterol alone, and 26% were using the SABA in combination with an inhaled corticosteroid or a leukotriene antagonist. All participants reported that their asthma was not well controlled or was very poorly controlled on a standard questionnaire. The mean age of the participants was 42 years (only 3% were adolescents), 30% were non-White, two-thirds were female, and 11% had experienced a severe exacerbation in the previous year. Groups were balanced at baseline, and although the primary analysis used the per-protocol population, results for the intention-to-treat analysis were also reported (and were similar). Participants could continue any maintenance therapy they were using at baseline (randomization was stratified by baseline medications) but they were randomized to use two puffs of budesonide 80 mcg plus albuterol 90 mcg or two puffs of albuterol 90 mcg alone from a rescue inhaler. Patients could take up to 6 doses (12 puffs) in a 24-hour period.

The investigators defined a severe exacerbation as requiring at least 3 days of systemic corticosteroids and an urgent care or emergency department visit, hospitalization, or death. Of the 2,516 people who were randomized, 2,424 were included in the per-protocol analysis and 1,797 in the intention-to-treat analysis. After approximately 1 year of follow-up, the albuterolbudesonide rescue inhaler group had fewer severe exacerbations in the intention-to-treat analysis (5.3% vs 9.4%; P < .001; number needed to treat = 26). The authors did not report the nature of the exacerbations (eg, a few days of taking oral corticosteroids vs an emergency department visit or hospitalization). Adverse events were similar between groups. The first draft of this manuscript was written by AstraZeneca, the manufacturer of the fixed-dose combination medication.

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry

Setting: Outpatient (any)

Reference: LaForce C, Albers F, Danilewicz A, et al.; BATURA Investigators. As-needed albuterol-budesonide in mild asthma. N Engl J Med. 2025;393(2):113-124.

Editor’s Note: Dr. Ebell is deputy editor for evidence-based medicine for AFP.