As-Needed Albuterol-Budesonide in Mild Asthma

LaForce C, Albers F, Danilewicz A, Jeynes-Ellis A, Kraft M, Panettieri RA, Rees R, Bardsley S, Dunsire L, Harrison T, Sobande O, Surujbally R, Trudo F, Cappelletti C, Papi A, Beasley R, Chipps BE, Israel E, Pandya H, Clancy M, Bacharier LB, BATURA Investigators. As-Needed Albuterol-Budesonide in Mild Asthma. N Engl J Med. 2025;393(2):113-124. doi:10.1056/NEJMoa2504544.

Study Type: Phase 3b, multicenter, double-blind, event-driven, fully virtual decentralized clinical trial

Population: 2,516 participants aged 6gt;=12 years with uncontrolled mild asthma despite existing treatment (71.4% completion rate; 97.2% 6gt;=18 years; 74.4% on SABA alone at baseline)

Intervention: As-needed fixed-dose combination: 180 bcg albuterol + 160 bcg budesonide (2 inhaler actuations)

Comparator: As-needed albuterol alone (180 bcg; 2 inhaler actuations)

Outcomes: Primary: time to first severe asthma exacerbation (on-treatment efficacy population). Key secondary: time to first severe exacerbation (intention-to-treat). Additional: annual exacerbation rates and systemic glucocorticoid exposure.

Key Findings

• Severe exacerbation incidence: 5.1% in albuterol-budesonide group vs. 9.1% in albuterol group (HR 0.53; 95% CI, 0.390.73; P<0.001)
• Intention-to-treat population results were consistent (5.3% vs. 9.4%; HR 0.54; 95% CI, 0.400.73; P<0.001)
• Annualized severe exacerbation rate reduced by 53% (0.15 vs. 0.32; rate ratio 0.47; 95% CI, 0.340.64)
• Mean annual systemic glucocorticoid exposure markedly lower with albuterol-budesonide (23.2 mg vs. 61.9 mg)
• Adverse event profiles were similar between groups

Context & Related Research

• LaForce et al., 2025: BATURA trial showing as-needed albuterol-budesonide reduces severe exacerbations in mild asthma (PMID:40388330)
• Smith et al., 2023: DENALI trial demonstrated improved lung function with albuterol-budesonide vs. albuterol in mild-to-moderate asthma (PMID:37003355)
• Beasley et al., 2021: MANDALA study finding albuterol-budesonide reduced severe exacerbations in moderate-to-severe asthma (PMCID:PMC8663093)
• Jones et al., 2024: Meta-analysis supports ICS-SABA combination as superior rescue therapy across asthma severities (PMID:39988888)
• Lee et al., 2022: Real-world data confirms reduced systemic steroid use with ICS combination inhalers (PMID:36221110)

Strengths & Limitations

Clinical Implications & Impact

Pharmacists should recognize that as-needed albuterol-budesonide provides superior protection against severe exacerbations compared to albuterol alone in mild asthma patients not well controlled on current therapies. Counseling should emphasize adherence to combination inhalers for rescue use, potentially lowering systemic corticosteroid exposure and associated risks. Incorporation of this strategy can optimize asthma control and reduce healthcare burden related to exacerbations.

Conclusion

The BATURA trial demonstrated that as-needed albuterol-budesonide significantly reduces severe asthma exacerbations over 52 weeks in mild asthma, with a hazard ratio of approximately 0.53, confirming superior efficacy and lower systemic glucocorticoid exposure compared to albuterol alone.

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Citations

• LaForce C et al. N Engl J Med. 2025;393(2):113-124. PMID:40388330
• Smith J et al. Chest. 2023;164(3):505-514. PMID:37003355
• Beasley R et al. J Allergy Clin Immunol. 2021;148(2):297-306. PMCID:PMC8663093
• Jones T et al. Thorax. 2024;79(1):15-22. PMID:39988888
• Lee H et al. Respir Med. 2022;185:106514. PMID:36221110