B22-23 Albuterol-budesonide Rescue Enhances Improvements in Control Compared With Albuterol Rescue for Patients With Mild Asthma

Abstract Rationale In BATURA, an event-driven study with up to 52 weeks’ treatment, as-needed albuterol-budesonide 180/160 µg decreased severe exacerbation risk by 46% versus albuterol 180 µg in patients with mild uncontrolled asthma ≥18 years (indicated age). Control was measured by The Asthma Impairment and Risk Questionnaire (AIRQ®), a validated tool comprising 10 equally weighted, yes/no items: 0-1 yes responses well-controlled (WC), 2-4 not well-controlled (NWC), 5-10 very poorly controlled (VPC) asthma. As AIRQ-measured control worsens, annual exacerbation occurrence increases (Beuther, JACI: In Practice, 2022), with VPC versus WC patients having 4.5-fold increased exacerbation risk. This BATURA post-hoc analysis compared effects of as-needed albuterol-budesonide versus albuterol on concurrent exacerbation risk reduction and asthma control over 28 weeks. Methods BATURA enrolled patients ≥12 years using short-acting β2-agonist (SABA) rescue ± low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance. Patients aged ≥18 years on randomized treatment (as-needed albuterol-budesonide or albuterol) and without maintenance step-up for ≥28 weeks were included here. A time-to-first analysis using a Cox proportional hazards model assessed exacerbation risk reduction over 16 and 28 weeks. AIRQ control category differences at baseline and weeks 16 and 28 were assessed by OR 95% CI. Endpoints were adjusted for treatment, pre-study therapy, and prior-year exacerbations; AIRQ analyses additionally adjusted for baseline control; statistical significance p ≤ 0.05. Results Among 2,353 patients ≥18 years, baseline mean age SD=43.5 13.9 years; 69% female; 74% SABA-only; 11% with prior-year severe exacerbations. Baseline characteristics among patients in the study ≥28 weeks (albuterol-budesonide, N = 834; albuterol, N = 795) were similar to the total population and balanced between treatments. At baseline, 1.2% of patients had WC, 47.3% NWC, and 51.6% VPC asthma, with no differences in control category distribution between arms (Figure). Over 16 and 28 weeks, as-needed albuterol-budesonide versus albuterol showed a 43% and 51% significant reduction in severe exacerbation risk. Correspondingly, the proportion of patients within each control category at 16 and 28 weeks differed between treatments, with odds of albuterol-budesonide versus albuterol recipients having WC asthma being 29% and 21% higher, and not being VPC 42% and 61% higher, respectively. The odds of baseline VPC asthma becoming WC at 16 weeks was 50% greater with albuterol-budesonide. Conclusions These observations show disease control in mild asthma varies over time, even when therapy is not increased. Many patients with uncontrolled mild asthma, including those with VPC disease, can achieve improved control and exacerbation risk reduction by switching from albuterol-only to albuterol-budesonide rescue. This abstract is funded by: The study was funded by Bond Avillion 2 Development LP. Statistical analyses presented here and medical writing support were funded by AstraZeneca.