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. 2017 Jul 29;4(1):e000217.
doi: 10.1136/bmjresp-2017-000217. eCollection 2017.

Description of the protocol for the PRACTICAL study: a randomised controlled trial of the efficacy and safety of ICS/LABA reliever therapy in asthma

James Fingleton  1   2 , Jo Hardy  1   3 , Christina Baggott  1   3 , Janine Pilcher  1   2 , Andrew Corin  4 , Robert J Hancox  5 , Matire Harwood  6 , Mark Holliday  1 , Helen K Reddel  7 , Philippa Shirtcliffe  1   2 , Suzanne Snively  1 , Mark Weatherall  8 , Richard Beasley  1   2
Affiliations

Description of the protocol for the PRACTICAL study: a randomised controlled trial of the efficacy and safety of ICS/LABA reliever therapy in asthma

James Fingleton et al. BMJ Open Respir Res. .

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.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Participant flow throughout the study.
See this image and copyright information in PMC

References

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