Batura: A fully virtual randomized controlled study of as-needed albuterol-budesonide vs albuterol in mild asthma

Abstract

Background

In MANDALA, rescue therapy with as-needed albuterol-budesonide 180/160 µg (ALB-BUD) pressurized metered-dose inhaler reduced severe exacerbation risk by 28% vs as-needed albuterol 180 µg (ALB) pressurized metered-dose inhaler, in patients aged 18 years or older with moderate-to-severe asthma. Information is limited on as-needed ALB-BUD use in patients with mild asthma, despite this population bearing substantial exacerbation risk and burden. The BATURA study (NCT05505734) examined the efficacy and safety of ALB-BUD vs ALB in participants with mild asthma.

Methods

BATURA, a fully virtual, phase IIIb, double-blind, event-driven study, randomized participants aged 12 years and older with mild asthma (using as-needed short-acting β₂-agonists ± low-dose inhaled corticosteroids/leukotriene modifiers) 1 to 1 to ALB-BUD or ALB, as-needed for symptoms, for 12 to 52 weeks. All trial-related visits were virtual. We reported severe exacerbation risk, measured as time-to-first severe exacerbation (defined as an exacerbation resulting in 3 days or longer systemic corticosteroid use, an emergency-room/urgent care visit for asthma requiring systemic corticosteroids, hospitalization, or death; primary endpoint) and safety.

Results

The BATURA study enrolled 2421 participants (1209 randomized to ALB-BUD and 1212 to ALB); the mean (SD) age was 42.7 (14.50) years; 2.8% were 12 to 17 years old and 68.3% female. Compared with ALB, ALB-BUD reduced severe exacerbation risk by 47% in a time-to-first-severe-exacerbation analysis (hazard ratio = 0.535, 95% CI: 0.392-0.730, P < .001). Similar percentages of participants experienced adverse events in both groups (Table 1).

Conclusion

In participants with mild asthma, the use of ALB-BUD as-needed rescue therapy for symptoms reduced the risk of a severe exacerbation by 47% compared with ALB. Both treatment groups had comparable safety profiles.