Abstract
What is this summary about?
This summary describes the results of a clinical study called MANDALA that was published in the New England Journal of Medicine in 2022. In the MANDALA study, researchers looked at a new asthma rescue inhaler that contains both albuterol and budesonide in a single inhaler (known as albuterol–budesonide, AIRSUPRA™). This summary describes the results for people aged 18 yearsand older who took part in the study.
Acknowledgments
AstraZeneca and Avillion would like to thank the clinical study participants and their family members and carers. They would also like to thank the investigators and staff at the study centers who cared for the participants in the clinical studies.
Declarations
Ethics approval and consent to participate: The trial design was approved by the appropriate institutional and national regulatory authorities and ethics committees; all the patients or their guardians provided written informed consent (and assent, if appropriate).
Consent for publication: Not applicable.
Author contributions: Alberto Papi: Investigation; Writing – review & editing.
Bradley E. Chipps: Investigation; Writing – review & editing.
Richard Beasley: Investigation; Writing – review & editing.
Reynold A. Panettieri Jr: Investigation; Writing – review & editing.
Elliot Israel: Investigation; Writing – review & editing.
Mark Cooper: Investigation; Writing – review & editing.
Lynn Dunsire: Formal analysis; Writing – review & editing.
Allison Jeynes-Ellis: Conceptualization; Writing – review & editing.
Robert Rees: Conceptualization; Writing – review & editing.
Frank C. Albers: Conceptualization; Writing – review & editing.
Christy Cappelletti: Investigation; Writing – review & editing.
Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Medical writing support was provided by Tanya Jandu of inScience Communications, Springer Healthcare Ltd., United Kingdom (funded by AstraZeneca). We thank Jodi Spiler for giving a patient review of this manuscript, which was reimbursed at fair market value and funded by AstraZeneca.
Competing interests: AP reports grants from Chiesi, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, TEVA, Sanofi, and consulting fees, honoraria for lectures or advisory boards from Chiesi, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Novartis, Sanofi, IQVIA, Avillion, Elpen Pharmaceuticals, Menarini, Zambon, and Mundipharma. BEC is an advisor for, has received consultancy fees from, and is on the speakers’ bureau for AstraZeneca, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Novartis, Regeneron, and Sanofi Genzyme. RB reports receiving grants from AstraZeneca, Cure Kids, the Health Research Council of New Zealand, Genentech, and GlaxoSmithKline; receiving personal fees from AstraZeneca, Avillion, Cipla, and Theravance; serving on advisory boards for AstraZeneca, Avillion, and Theravance; and serving as the chair of the adolescent and adult asthma guidelines group for the Asthma and Respiratory Foundation NZ outside the submitted work. RAP Jr reports grants and advisory board support from AstraZeneca, Sanofi, Genentech, Medimmune, Origa Pharma, Amgen, RIFM, NIH, Regeneron, and Novartis. EI reports personal fees from AB Science, Allergy and Asthma Network, Biometry, Equillium, Merck, NHLBI, 4D Pharma, Pneuma Respiratory, PPS Health, Regeneron, Sanofi Genzyme, and Sienna Biopharmaceutical; grants and personal fees from Amgen, AstraZeneca, Avillion, and Novartis; personal fees and non-financial support from Genentech, GlaxoSmithKline, and TEVA; grants from Gossamer Bio; grants and non-financial support from Circassia; non-financial support from Boehringer Ingelheim; and other from Vorso Corp, outside the submitted work. CC, MC, and LD are employees of, and hold stock in, AstraZeneca. FCA, RR, and AJ-E are employees of Avillion.
Availability of data and materials: Data underlying the findings described in this manuscript may be obtained in accordance with the data sharing policy of Avillion’s codevelopment partner AstraZeneca, as described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure