Article Text
Abstract
Introduction In adult asthma, combination inhaled corticosteroid (ICS)/fast-onset long-acting beta agonist (LABA) used solely as reliever therapy may represent an effective and safe alternative to ICS maintenance and short-acting beta agonist (SABA) reliever therapy.
Objective To compare the efficacy and safety of ICS/fast-onset LABA reliever therapy with ICS maintenance and SABA reliever therapy in adults with asthma.
Methods and analysis A 52-week, open-label, parallel group, multicentre, phase III randomised controlled trial with 1:1 randomisation to either budesonide/formoterol Turbuhaler 200/6 µg, one actuation as required for symptom relief, or budesonide Turbuhaler 200 µg, one actuation twice daily and terbutaline Turbuhaler 250 µg, two actuations as required for symptom relief. 890 adults aged 18–75 years with asthma for whom maintenance ICS and SABA reliever therapy is indicated by current guidelines will be recruited in New Zealand. The primary outcome variable is the rate of severe exacerbations per patient per year. This study will investigate a novel treatment regimen that might lead to a paradigm shift in asthma management for adults for whom guidelines currently recommend maintenance ICS and SABA reliever therapy.
Ethics and dissemination Ethical approval has been granted (15/NTB/178). Study findings will be published according to Iinternational Committee of Medical Journal Editors' recommendations.
Trial registration number ACTRN12616000377437; Pre-results.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
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Contributors RB conceived the study and finalised the study design and secured funding from the HRC and Genentech with the assistance of the steering committee. JP wrote the first draft of the protocol. JF and RB wrote the first draft of the manuscript. All authors were involved in the design of the study protocol and reviewed this manuscript prior to submission.
Funding The primary funding is being provided by the Health Research Council of New Zealand, through a programme grant to the MRINZ: reference number 15/573. The PRACTICAL study has undergone full external peer review as part of the funding process. The funding agreement is made between the HRC and MRINZ, as Sponsor. Funding for the collection materials, shipping and analysis of periostin and future unspecified research samples will be provided by Genentech Inc. This funding agreement is made between Genentech and MRINZ, as Sponsor.
Competing interests JF has received support to attend educational meetings from AstraZeneca and Boehringer Ingelheim. JP is an HRC Clinical Research Training Fellow. AC is a Pharmac PTAC respiratory subcommittee member and has received honoraria from AstraZeneca and GlaxoSmithKline for speaking and advisory board work. HKR has participated in advisory boards for AstraZeneca (including the Steering Committee for the SYGMA studies), GlaxoSmithKline, Merck and Novartis; has presented independent medical education at symposia funded by AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Mundipharma and Teva; and has received independent research funding from GlaxoSmithKline and AstraZeneca. RB has participated in advisory boards for AstraZeneca, GlaxoSmithKline and Novartis; received research grants from AstraZeneca, Cephalon, Genentech, GlaxoSmithKline, Novartis and Sanofi Aventis; and received payment for lectures or support to attend meetings from AstraZeneca and GlaxoSmithKline. Other authors have no relevant competing interests.
Ethics approval Northern B Health and Disability Ethics Committee of New Zealand.
Provenance and peer review Not commissioned; internally peer reviewed.