The Anti-Inflammatory Reliever (AIR) Algorithm Study: a protocol for a single-group study of an AIR stepwise approach to the treatment of adult asthma.

Background

The stepwise approach to long-term asthma management, which traditionally incorporates short-acting β

Objective

The aim of this study was to evaluate the AIR stepwise approach recommended by the New Zealand adolescent and adult asthma guidelines, in combination with a novel algorithm for transitioning between treatment steps.

Methods

This 52-week, open-label, single-group study will recruit 100 adults aged 18 to 75 years with mild, moderate and moderate-severe asthma (ACTRN12620001010987). Participants will be allocated to budesonide-formoterol 200/6 µg, one actuation as needed (Step 1), one actuation twice daily and as needed (Step 2), or two actuations twice daily and one as needed (Step 3). Treatment steps will be adjusted throughout the study, in response to reliever use and asthma attacks, according to a stepwise AIR algorithm. Following a 26-week period of investigator-led transitions, participants will adjust their own treatment step. The primary outcome is participant satisfaction as measured by the Global Satisfaction score of the Treatment Satisfaction Questionnaire for Medication. Secondary outcomes will assess efficacy and safety, and describe patterns of medication use and participant flow through the treatment steps.

Conclusion

This is the first trial to assess the AIR treatment track and algorithm. The results will provide knowledge to guide the clinical use of this approach.

Informations de copyright

Copyright ©The authors 2023.

Déclaration de conflit d'intérêts

Conflict of interest: M. Holliday reports support for the present manuscript from AstraZeneca (to the Medical Research Institute of New Zealand) for inhaler monitor devices and associated costs and study drugs provided free of charge. Conflict of interest: A. Semprini reports grants or contracts from the Health Research Council of New Zealand, and NZ Pharmacy Education and Research Foundation, outside the submitted work. Conflict of interest: I. Pavord reports support for manuscript writing from GSK and Fishawack Health, outside the submitted work; grants or contracts from Chiesi, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, Boehringer Ingelheim, Aerocrine, Almirall, Novartis, Teva, Chiesi, Sanofi/Regeneron, Menarini and GSK; payment for expert testimony from AstraZeneca and Teva; support for attending meetings and/or travel from GSK, Boehringer Ingelheim, AstraZeneca, Teva and Chiesi, outside the submitted work; patents planned, issued or pending for Merck Co. (patent holder of right to Leicester Cough Questionnaire), Bayer and Insmed, outside the submitted work; and participation on a data safety monitoring board or advisory board for Genentech, Sanofi/Regeneron, AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Teva, Merck, Circassia and Chiesi, outside the submitted work. Conflict of interest: T. Harrison is an employee of AstraZeneca and owns stock. Conflict of interest: A. Papi reports grants or contracts from Chiesi, AstraZeneca, GSK, Sanofi and Agenzia Italiana del Farmaco, outside the submitted work; consulting fees from Chiesi, AstraZeneca, GSK, Novartis, Sanofi, Avillion and Elpen Pharmaceutica, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Chiesi, AstraZeneca, GSK, Menarini, Novartis, Zambon, Mundipharma, Sanofi, Edmond Pharma, Iqvia, Avillion and Elpen Pharmaceuticals, outside the submitted work; and participation on advisory boards for Chiesi, AstraZeneca, GSK, MSD, Novartis, Sanofi, Iqvia, Avillion and Elpen Pharmaceuticals, outside the submitted work. Conflict of interest: R. Horne reports royalties or licences from GSK, AstraZeneca, TEVA, Novartis, UCB, Eli Lilly, Sanofi, Pfizer and Gilead, outside the submitted work; consulting fees from AstraZeneca, UCB, Daiichi, Sciencus, Esai and Vertex, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AbbVie, Abbott, Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, Biogen, Gilead Sciences, GlaxoSmithKline, Janssen, Merck Sharp Dohme, Merck, Novartis, Pfizer, Procter & Gamble, Roche, Sanofi, Shire, TEVA and UCB, outside the submitted work; participation on advisory boards for AstraZeneca, UCB, Abbott and Novartis, outside the submitted work; and stock or stock options as Founding Director of a UCL-Business company (Spoonful of Sugar Ltd) providing consultancy on treatment engagement and patient support programmes to healthcare policy makers, providers and pharmaceutical industry. Conflict of interest: R. Beasley reports support for the present manuscript form AstraZeneca and the Health Research Council of New Zealand; grants or contracts from AstraZeneca, Genentech and the Health Research Council New Zealand Cure Kids (NZ), outside the submitted work; consulting fees from AstraZeneca, Cipla, Avillion, the Health Research Council New Zealand, CSL Seqirus and Teva Pharmaceuticals, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, Cipla, Avillion, the Health Research Council New Zealand, CSL Seqirus and Teva Pharmaceuticals, outside the submitted work; support for attending meetings and/or travel from AstraZeneca, Cipla, Avillion, the Health Research Council New Zealand, CSL Seqirus and Teva Pharmaceuticals, outside the submitted work; participation on a data safety monitoring board or advisory board for AstraZeneca, Cipla, Avillion, the Health Research Council New Zealand, CSL Seqirus and Teva Pharmaceuticals, outside the submitted work; and is Chair for Asthma and Respiratory Foundation NZ adolescent and adult asthma guidelines, a Member of the GOLD Board, and a Consultant for GINA. All other authors have no conflicts to declare.