Albuterol/Budesonide Reduces Risk of Severe Exacerbation in Patients With Asthma

Positive high-level results from the phase 3b BATURA clinical trial (NCT05505734) indicate that compared with as-needed albuterol, albuterol/budesonide (formerly PT027, Airsupra; AstraZeneca) demonstrated a statistically significant and clinically meaningful reduction in the risk of severe exacerbation when used as an as-needed rescue medication patients with intermittent or mild persistent asthma.¹

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Albuterol/budesonide is the first and only anti-inflammatory rescue medication approved in the US for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations experienced by patients with asthma who are aged 18 years and older. The first-in-class short-acting beta2-agonists (SABA)/inhaled corticosteroid (ICS) was approved by the FDA in January 2023 following results from the phase 3 MANDALA (NCT03769090) and DENALI (NCT03847896) trials, which demonstrated significantly significant reductions in the risk of severe exacerbation and improvements in lung function measured by FEV1, respectively, in patients with moderate to severe asthma.^1,2

BATURA (NCT05505734) is a multicenter, randomized, double-blind, parallel-group phase 3b clinical trial that compared albuterol/budesonide with albuterol alone in patients aged 12 years and older. Patients with intermittent or mild persistent asthma were enrolled, including those on SABAs alone, ICS maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy. The enrolled patients were randomly assigned to receive either 2 inhalations per dose of albuterol/budesonide (90/80 μg), or 2 inhalations per dose of albuterol (90 μg), both of which were administered daily as needed. Both groups were able to receive up to a maximum of 12 inhalations to max dose.^1,3

The primary outcome for BATURA was the time to first severe asthma exacerbation, which was measured up to week 52. Secondary outcomes included annualized rate of severe asthma exacerbations, total amount and total days of systemic glucocorticoid exposure, and number of participants with adverse events (AEs) and serious AEs (SAEs), which were also assessed up to week 52.³

According to the investigators, albuterol/budesonide met its primary end point, demonstrating a statistically significant and clinically meaningful reduction in the risk of severe exacerbation compared with albuterol alone. Detailed data will be shared at an oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26, 2024.¹

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time,” said James Donohue, emeritus professor of pulmonary medicine, University of North Carolina, chair of Independent Data Monitoring Committee, in a news release.¹

The safety and tolerability of albuterol/budesonide in the BATURA trial was observed to be consistent with its previously established profile, with no new safety concerns reported. According to the investigators, common AEs of albuterol/budesonide can include headache, cough, and hoarseness, with potential SAEs including heart problems, allergic reactions, weakened immune system and increased chance of infections, and difficulty breathing, coughing, and wheezing. In the MANDALA trial, the most common AEs observed were nasopharyngitis and headache.^1,2

“The impressive BATURA trial results add to the body of evidence supporting [albuterol/budesonide] as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids,” said Sharon Barr, executive vice president, BioPharmaceuticals R&D, AstraZeneca, in the news release.¹

REFERENCES

1. AstraZeneca. AIRSUPRA® (albuterol/budesonide) demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial. News release. October 7, 2024. Accessed October 7, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/airsupra-positive-results-phase-iii-batura-trial.html

2. AstraZeneca. Airsupra (PT027) approved in the US for asthma. News release. January 11, 2023. Accessed October 7, 2024. https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html

3. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma. ClinicalTrials.gov identifier: NCT05505734. Updated August 29, 2024. Accessed October 7, 2024. https://clinicaltrials.gov/study/NCT05505734