EFFECTS OF ALBUTEROL-BUDESONIDE ON ASTHMA DETERIORATIONS AND SEVERE EXACERBATIONS IN MILD-TO-MODERATE ASTHMA: DENALI EXPLORATORY ENDPOINTS

Abstract

<h3>Introduction</h3> Albuterol-budesonide fixed-dose combination (FDC) inhaler as needed reduced risk of a severe exacerbation by 27% compared with albuterol in patients with moderate-to-severe asthma. DENALI is a Phase 3 study (NCT03847896), which confirmed the contribution of both mono-components in the albuterol-budesonide FDC to lung function efficacy when used four-times daily (QID) over 12 weeks in patients with mild-to-moderate asthma. Here, we explore the effects of albuterol-budesonide on asthma deteriorations and severe asthma exacerbations relative to its mono-components and placebo. <h3>Methods</h3> Patients aged ≥12 years (FEV₁ ≥50-<85% predicted normal, ≥15% reversibility) were randomized 1:1:1:1:1 to albuterol-budesonide 180/160μg, albuterol-budesonide 180/80μg, albuterol 180μg, budesonide 160μg, or placebo, all QID, for 12 weeks. Asthma deteriorations and severe exacerbations were collected as exploratory endpoints (Table). <h3>Results</h3> 989 patients were included in the analysis. The percentage of patients experiencing ≥1 asthma deterioration was 34.5% and 42.3% in the albuterol-budesonide 180/160μg and 180/80μg groups, respectively, versus 58.7%, 47.7%, and 53.6% in the albuterol, budesonide, and placebo groups, respectively (Table). Severe exacerbations were experienced by numerically fewer patients receiving albuterol-budesonide 180/160μg and 180/80μg versus albuterol and placebo (2.0% and 2.5% vs 10.2% and 7.1%, respectively), and days with severe exacerbations were numerically fewer with albuterol-budesonide 180/160μg versus albuterol, budesonide, and placebo (Table). Safety was similar across treatment groups. <h3>Conclusions</h3> In this 12-week study in mild-to-moderate asthma, patients receiving albuterol-budesonide QID experienced numerically fewer asthma deteriorations and severe exacerbations than those receiving albuterol or placebo QID, and, at 180/160µg, numerically fewer days with severe exacerbations versus budesonide. All study drug administered QID.