Topline results were announced from two phase 3 studies evaluating a fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS), in patients with asthma.
The multicenter, randomized, double-blind, parallel-group MANDALA trial (ClinicalTrials.gov Identifier: NCT03769090) evaluated the efficacy and safety of albuterol/budesonide on the time to first severe asthma exacerbation in 3132 patients aged 4 years and older with moderate to severe asthma who were receiving ICS with or without additional medications. Patients were randomly assigned 1:1:1: to receive albuterol/budesonide 180/160mcg, albuterol/budesonide 180/80mcg, or albuterol sulfate metered-dose inhaler 180mcg, as a rescue medication in response to symptoms.
Results showed that patients treated with albuterol/budesonide met the primary endpoint demonstrating statistically significant and clinically meaningful reductions in the risk of severe exacerbations compared with albuterol.
The multicenter, randomized, double-blind, placebo-controlled, parallel-group DENALI trial (ClinicalTrials.gov Identifier: NCT03847896) evaluated the efficacy and safety of albuterol/budesonide in 1001 patients aged 4 years and older with mild to moderate asthma previously treated with either SABA as needed alone or in addition to low-dose maintenance ICS therapy. Patients were randomly assigned 1:1:1:1:1 to receive albuterol/budesonide 180/160mcg, albuterol/budesonide 180/80mcg 4 times daily, albuterol metered-dose inhaler 180mcg 4 times daily, budesonide metered-dose inhaler 160mcg 4 times daily, or placebo.
Results showed that patients treated with the combination therapy met the primary endpoints demonstrating statistically significant improvements in lung function compared with the individual components and placebo. Lung function was measured by the change from baseline in forced expiratory volume in one second (FEV1) from 0 to 6 hours over 12 weeks and by the change from baseline in trough FEV1.
Detailed data from both trials will be presented at an upcoming medical meeting.
Fixed-dose combination of albuterol and budesonide (PT027) demonstrated significant benefits for asthma patients in MANDALA and DENALI Phase III trials. News release. September 9, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/pt027-phiii-asthma-trials-met-primary-endpoints.html.