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In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial
  1. Matshediso C Mokoka1,
  2. Lorna Lombard1,
  3. Elaine M MacHale1,
  4. Joanne Walsh1,
  5. Breda Cushen1,
  6. Imran Sulaiman1,
  7. Damien Mc Carthy1,
  8. Fiona Boland2,
  9. Frank Doyle2,
  10. Eoin Hunt3,
  11. Desmond M Murphy3,
  12. John Faul4,
  13. Marcus Butler5,
  14. Kathy Hetherington6,
  15. J Mark FitzGerald7,
  16. Job FM van Boven8,
  17. Liam G Heaney6,
  18. Richard B Reilly9,
  19. Richard W Costello10
  1. 1 Clinical Research Centre, Smurfit Building Beaumont Hospital, RCSI, Dublin, Ireland
  2. 2 Division of Population Health Sciences, RCSI, Dublin, Ireland
  3. 3 Department of Respiratory Medicine, University Hospital Cork and Clinical Research Facility, University College Cork, Cork, Ireland
  4. 4 Department of Respiratory Medicine, Connolly University Hospital, Dublin, Ireland
  5. 5 Department of Respiratory Medicine, St Vincent’s Hospital Dublin, Dublin, Ireland
  6. 6 Centre for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queens University, Belfast, UK
  7. 7 Respiratory Medicine Division, University of British Colombia, Vancouver, Canada
  8. 8 Unit of Pharmaco-epidemiology & Pharmaco-economics, Department of Pharmacy, University of Groningen, Groningen, The Netherlands
  9. 9 Trinity Centre for Bioengineering, Trinity College, University of Dublin, Dublin, Ireland
  10. 10 Department of Medicine, RCSI, Dublin, Ireland
  1. Correspondence to Dr Matshediso C Mokoka; matshedisocm{at}rcsi.ie

Abstract

Introduction Many patients with asthma remain poorly controlled despite the use of inhaled corticosteroids and long-acting beta agonists. Poor control may arise from inadequate adherence, incorrect inhaler technique or because the condition is refractory. Without having an objective assessment of adherence, clinicians may inadvertently add extra medication instead of addressing adherence. This study aims to assess if incorporating objectively recorded adherence from the Inhaler Compliance Assessment (INCA) device and lung function into clinical decision making provides more cost-effective prescribing and improves outcomes.

Methods and analysis This prospective, randomised, multicentre study will compare the impact of using information on adherence to influence asthma treatment. Patients with severe uncontrolled asthma will be included. Data on adherence, inhaler technique and electronically recorded peak expiratory flow rate will be used to promote adherence and guide a clinical decision protocol to guide management in the active group. The control group will receive standard inhaler and adherence education. Medications will be adjusted using a protocol based on Global Initiativefor Asthma (GINA) recommendations. The primary outcome is the between-group difference in the proportion of patients who have refractory disease and are prescribed appropriate medications at the end of 32 weeks. A co-primary outcome is the difference between groups in the rate of adherence to salmeterol/fluticasone inhaler over the last 12 weeks. Secondary outcomes include changes in symptoms, lung function, type-2 cytokine biomarkers and clinical outcomes between both groups. Cost-effectiveness and cost-utility analyses of the INCA device intervention will be performed. The economic impact of a national implementation of the INCA-SUN programme will be evaluated.

Ethics and dissemination The results of the study will be published as a manuscript in peer-reviewed journals. The study has been approved by the ethics committees in the five participating hospitals.

Trial registration NCT02307669; Pre-results.

  • severe uncontrolled asthma
  • adherence
  • INCA electronic monitor
  • randomisedcontrolled trial
  • inhaler technique.

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

  • Contributors RBR and RWC conceived the INCA device. RWC, LGH and JMF designed the study. MCM, LL, IS, BC, EMH, KH, DMC, FD, EH, DMM, JF, MB and JW each made substantial contributions to study design, eCRF and designing the physician script. FB, JFMvB and MCM provided the statistical support. MCM and RWC contributed to the drafting of the manuscript. All authors were involved in the writing of the manuscript by revising it critically for intellectual content. All authors read and approved the final manuscript.

  • Funding This study is supported by the Health Research Board of Ireland (Grant Number: HRA-D1-2014-683, Grant Code: HRB DI 59). GlaxoSmithKline is also supporting funding and will be providing fluticasone, salmeterol/fluticasone and salbutamol. The study protocol has undergone peer review by the funding body. The trial was registered on Clinicaltrials.gov, as NCT02307669 on 21 April 2014.

  • Competing interests None declared.

  • Ethics approval The study is approved by Beaumont Hospital research ethics committee, Cork Teaching Hospitals clinical research ethics committee, James Connolly Hospital research ethics committee, St Vincent’s Healthcare Group ethics and HSC research ethics committee Northern Ireland. All eligible participants will sign informed consent form. Protocol amendments must be approved by ethics committees of participating sites and will be communicated to all investigators, trial registries, trial regulators and trial participants if deemed necessary.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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