(404) Efficacy of as-needed albuterol–budesonide versus albuterol on systemic corticosteroid exposure in participants with mild asthma: BATURA prespecified analysis

Wednesday, October 29, 2025

Primary Author(s)

Reynold A. Panettieri Jr., MD

Vice Chancellor for Translational Medicine and Science
Rutgers Institute for Translational Medicine and Science, Rutgers, The State University of New Jersey, NJ, United States
New Brunswick, New Jersey, United States

Co-Author(s)

Leonard Bacharier, n/a

Professor of Pediatrics
Monroe Carell Jr Children’s Hospital at Vanderbilt University Medical Center, Nashville, TN, USA
Nashville, Tennessee, United States
Monica Kraft, MD

System Chair, Samuel Bronfman Department of Medicine
Department of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, NY, United States
New York, New York, United States
Richard Beasley, DSc

Director, Founder, Asthma Programme Lead, Oxygen Programme Co-Lead
Medical Research Institute of New Zealand, Wellington, New Zealand
Wellington, Wellington, New Zealand
Bradley E. Chipps, MD

Allergist and Immunologist
Capital Allergy and Respiratory Disease Center, Sacramento, CA, United States
Sacramento, California, United States
Elliot Israel, MD

Gloria M. and Anthony C. Simboli Endowed Chair in Asthma Research
Divisions of Pulmonary and Critical Care Medicine and Allergy and Immunology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, United States
Boston, Massachusetts, United States
Christy Cappelletti, PharmD

Senior Group Director, Late Stage Development, Late Respiratory, Immunology, and Infection
BioPharmaceuticals R&D, AstraZeneca, Durham, NC, United States
Durham, North Carolina, United States
Martin Clancy, MSc

Principal Statistician
Phastar, London, United Kingdom
London, England, United Kingdom
Alberto Papi, MD

Professor of Respiratory Medicine
Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy
Ferrara, Emilia-Romagna, Italy
Craig LaForce, MD

Medical Director
North Carolina Clinical Research, Raleigh, NC, United States
Chapel Hill, North Carolina, United States
Frank Albers, MD, PhD

Senior Global Medical Lead
Avillion US Inc., Northbrook, IL, United States
Northbrook, Illinois, United States
Anna Danilewicz, BSc

Vice President, Clinical Development
Avillion Life Sciences Ltd., London, United Kingdom
London, England, United Kingdom
Allison Jeynes-Ellis, MD

Chief Executive Officer
Avillion Life Sciences Ltd., London, United Kingdom
London, England, United Kingdom
Robert Rees, PhD

Senior Director, Clinical Programs
Avillion Life Sciences Ltd., London, United Kingdom
London, England, United Kingdom
Sam Bardsley, MSc

Group Product Leader
BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, United Kingdom
Cambridge, England, United Kingdom
Lynn Dunsire, MSc

Statistical Science Director
BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, United Kingdom
Cambridge, England, United Kingdom
Tim Harrison, MD

Head of Inhaled Asthma Portfolio
BioPhamaceuticals, Global Medical Affairs, AstraZeneca Cambridge, United Kingdom
Cambridge, England, United Kingdom
Hitesh Pandya, MD, MBA

Global Clinical Head, Respiratory & Inflammation
BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, United Kingdom
Cambridge, England, United Kingdom
Olami Sobande, MD

Global Clinical Program Lead
BioPharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MA, United States
Gaithersburg, Maryland, United States

Presenter(s)

Sunny Hirpara, PharmD

Clinical Account Director
Biopharmaceuticals, Global Patient Safety, AstraZeneca, Wilmington, DE, United States
Wilmington, Delaware, United States

Background: : Rescue therapy with as-needed albuterol–budesonide 180/160 µg (ALB–BUD) reduced the risk of a severe exacerbation by 47% compared with albuterol 180 µg (ALB) in participants with mild asthma in the BATURA trial. Limited but growing evidence in the literature suggests that even very brief dosing periods (3–7 days) of systemic corticosteroids (SCS) are enough to cause clinically important systemic adverse effects for patients.

Objective: : The efficacy of ALB–BUD to reduce SCS exposure compared with ALB is presented in this prespecified analysis of BATURA.

Methods: : BATURA (NCT05505734), a phase 3b, double-blind, event-driven study, randomized participants ≥12 years of age with mild asthma (using as-needed short-acting β2-agonists ± low-dose inhaled corticosteroids or leukotriene modifiers) 1:1 to ALB–BUD or ALB, as-needed for 12–52 weeks. Severe exacerbations were defined as an exacerbation resulting in ≥3 days SCS use, an emergency-room/urgent care visit for asthma requiring SCS, hospitalization, or death. Here, we report the difference in total SCS exposure between treatment groups in prednisone equivalents.

Results: : BATURA enrolled 2,421 participants (1,209 randomized to ALB–BUD, 1,212 to ALB). The median (interquartile range [IQR]) days on SCS per exacerbation was the same for both groups (6 [5, 8] days). The median (IQR) daily dose of SCS per exacerbation was 26.7 (20, 40) mg for ALB–BUD and 28.7 (20, 41.2) mg for ALB. A total (annualized) of 263.4 and 549.0 courses of SCS were administered during the trial to the ALB–BUD and ALB groups, respectively, corresponding to a total (annualized) of 928.9 and 2066.8 days of SCS exposure, respectively. Mean annualized SCS exposure per patient was 23.2 mg in the ALB–BUD group and 61.9 mg in the ALB group, a difference of 38.7 mg and a 62.5% reduction (P < 0.001; Wilcoxon rank sum test). In the subgroup of participants aged ≥18 years, the mean annualized SCS exposure per patient was 23.0 mg in the ALB–BUD group and 63.0 mg in the ALB group, a difference of 40.0 mg and a 63.5% reduction (P < 0.001; Wilcoxon rank sum test). Total SCS exposure for the overall population was 2.7-fold greater in the ALB group compared to the ALB–BUD group.

Conclusions: : In participants with mild asthma in the BATURA trial, rescue therapy with as-needed ALB–BUD reduced the total SCS exposure compared with ALB, reducing known risks from cumulative exposure to SCS.

Sponsorship:: Bond Avillion 2 Development LP and AstraZeneca.