Two combinations of albuterol and budesonide used as a rescue medication demonstrated a statistically significant reduction in the risk of a severe exacerbation in patients with moderate to severe asthma, compared to albuterol alone, according to Phase 3 clinical trial results presented at ATS 2022 by AstraZeneca.1,2
The therapeutic, PT027, is a potential first-in-class inhaled, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide (an inhaled corticosteroid). The drug combination is being developed by AstraZeneca and Avillion.
Compared with albuterol rescue, PT027 at the 180mcg albuterol +160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p<0.001) in adults and adolescents.1,2 In the trial, patients were randomized to receive PT027 or albuterol rescue, on top of their usually prescribed maintenance ICS, with or without additional controller medicines.1,2
In secondary endpoints, PT027 (180mcg albuterol + 160mcg budesonide) demonstrated a 33% reduction in mean annualized total systemic corticosteroid exposure (p=0.002) and a 24% reduction in annualized severe exacerbation rate (p=0.008).1,2 A numerically higher odds of patients experiencing an improvement in symptom control and quality of life was also observed after 24 weeks of treatment with PT027 compared to albuterol rescue.1,2
Adverse events (AEs) were similar across the treatment groups in the trial and consistent with the known safety profiles of the individual components, with the most common AEs including nasopharyngitis and headache.1
Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said:
“The MANDALA Phase III trial results demonstrated that PT027, a novel fixed-dose combination of albuterol and budesonide used as-needed, provided additional anti-inflammatory treatment in response to patient symptoms, which led to a reduced risk of severe exacerbations compared with albuterol alone. These data further strengthen the growing body of evidence around the value of as-needed anti-inflammatory treatment in asthma and support PT027’s potential to transform the current rescue treatment approach.”