BATURA
Trial question
What is the role of as-needed albuterol/budesonide in patients with mild asthma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
68.0% female
32.0% male
N = 2421
2421 patients (1653 female, 768 male).
Inclusion criteria: patients, aged ≥ 12 years, with mild asthma uncontrolled with a short-acting β-agonist, with or without a low-dose inhaled glucocorticoid or leukotriene receptor antagonist.
Key exclusion criteria: evidence of significant lung disease other than asthma; hospitalization due to asthma in the past 3 months; self-reported use of systemic corticosteroids for the treatment of asthma and any other condition in the last 6 weeks; receipt of bronchothermoplasty; pregnancy or lactation.
Interventions
N=1209 albuterol/budesonide (180/160 mcg on an as-needed basis for up to 52 weeks).
N=1212 albuterol (180 mcg on an as-needed basis for up to 52 weeks).
Primary outcome
First severe asthma exacerbation, time-to-event analysis
5.1%
9.1%
9.1 %
6.8 %
4.5 %
2.3 %
0.0 %
Albuterol/budesonide
Albuterol
Significant
decrease ▼
NNT = 25
Significant decrease in first severe asthma exacerbation, time-to-event analysis (5.1% vs. 9.1%; HR 0.53, 95% CI 0.39 to 0.73).
Secondary outcomes
Significant decrease in first severe asthma exacerbation, intention-to-treat population (5.3% vs. 9.4%; HR 0.54, 95% CI 0.4 to 0.73).
Significant decrease in annualized rate of severe asthma exacerbations (0.15 events vs. 0.32 events; RR 0.47, 95% CI 0.34 to 0.64).
Significant decrease in the incidence of mean annual total dose of systemic glucocorticoids (23.2 mg / y vs. 61.9 mg / y; MD -38.7, 95% CI -61.66 to -15.74).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients, aged ≥ 12 years, with mild asthma uncontrolled with a short-acting β-agonist, with or without a low-dose inhaled glucocorticoid or leukotriene receptor antagonist, albuterol/budesonide was superior to albuterol with respect to first severe asthma exacerbation, time-to-event analysis.
Reference
Craig LaForce, Frank Albers, Anna Danilewicz et al. As-Needed Albuterol-Budesonide in Mild Asthma. N Engl J Med. 2025 May 19. Online ahead of print.
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