Albuterol-budesonide Fixed-dose Combination (FDC) Inhaler As-needed Reduces Progression from Symptomatic Deterioration to Severe Exacerbation in Patients with Moderate-to-severe Asthma: Analysis from MANDALA

Short-acting β2-agonists (SABAs) treat symptoms, but not the underlying inflammation. A “window of opportunity” may exist to prevent severe exacerbations if symptoms and inflammation are treated concomitantly, as advocated by GINA and NAEPP. In the Phase 3 MANDALA study (NCT03769090), as-needed albuterol-budesonide 180/160μg FDC significantly reduced severe exacerbation risk by 27%, annualized severe exacerbation rate by 24%, and annualized total systemic corticosteroid exposure mean was reduced by 33% versus albuterol.