Original Article
Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes

https://doi.org/10.1016/j.jaip.2017.01.004Get rights and content

Background

Poor inhaler technique has been linked to poor asthma outcomes. Training can reduce the number of inhaler errors, but it is unknown which errors have the greatest impact on asthma outcomes.

Objective

The CRITical Inhaler mistaKes and Asthma controL study investigated the association between specific inhaler errors and asthma outcomes.

Methods

This analysis used data from the iHARP asthma review service—a multicenter cross-sectional study of adults with asthma. The review took place between 2011 and 2014 and captured data from more than 5000 patients on demographic characteristics, asthma symptoms, and inhaler errors observed by purposefully trained health care professionals. People with asthma receiving a fixed-dose combination treatment with inhaled corticosteroids and long-acting beta agonist were categorized by the controller inhaler device they used—dry-powder inhalers or metered-dose inhalers: inhaler errors were analyzed within device cohorts. Error frequency, asthma symptom control, and exacerbation rate were analyzed to identify critical errors.

Results

This report contains data from 3660 patients. Insufficient inspiratory effort was common (made by 32%-38% of dry-powder inhaler users) and was associated with uncontrolled asthma (adjusted odds ratios [95% CI], 1.30 [1.08-1.57] and 1.56 [1.17-2.07] in those using Turbohaler and Diskus devices, respectively) and increased exacerbation rate. In metered-dose inhaler users, actuation before inhalation (24.9% of patients) was associated with uncontrolled asthma (1.55 [1.11-2.16]). Several more generic and device-specific errors were also identified as critical.

Conclusions

Specific inhaler errors have been identified as critical errors, evidenced by frequency and association with asthma outcomes. Asthma management should target inhaler training to reduce key critical errors.

Section snippets

Data source and permissions

This study, labeled the CRITIKAL study, used data from the iHARP (initiative Helping Asthma in Real-life Patients18) database—an asthma review service supported by the Respiratory Effectiveness Group.19 iHARP collected data prospectively between June 2011 and December 2014 in participating primary care practices in Australia and 7 European countries (United Kingdom, Italy, Spain, the Netherlands, France, Norway, and Sweden). Each of these practices received an identical iHARP asthma review

Patients

After applying inclusion and exclusion criteria, 4276 patients with asthma were available for study in the iHARP database. Six device cohorts were formed, on the basis of the type of inhaler device used by patients. Three of these cohorts were excluded from the final study sample because they did not have a sufficient sample size for the main analysis. The excluded device cohorts were Seretide MDI with spacer (Glaxo Wellcome Operations, Ware, UK) (n = 242), Fostair MDI (Chiesi Farmaceutici,

Discussion

Previous studies have shown that poor or improper inhaler technique in asthma is associated with reduced control10, 11 and increased hospital visits.10 The CRITIKAL study is the first study to observe associations between specific inhaler errors and poorer asthma outcomes, including increased likelihood of having uncontrolled symptoms and increased exacerbation rate. Errors were frequent (made by over 30% of patients in a number of cases), and were device-specific as well as generic across

Conclusions

Specific inhaler errors have been identified as critical errors, evidenced by frequency and association with poor asthma outcomes. Primary and secondary care management should target inhaler training to reduce critical errors.

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    This work was funded by Mundipharma Research Limited.

    Conflicts of interest: D.B. Price is on the boards for Aerocrine, Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; has received consultancy fees from Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; has received grants and unrestricted funding for investigator-initiated studies (conducted through Research in Real-Life Ltd [RiRL] and Observational and Pragmatic Research Institute Pte Ltd) from UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Eli Lilly, GSK, Meda, Merck, Mundipharma, Napp, Novartis, Orion, Pfizer, Respiratory Effectiveness Group, Takeda, Teva Pharmaceuticals, and Zentiva; has received lecture fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; has patents (planned, pending, or issued) from AKL Ltd; has received payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; has received payment for developing educational presentations from GlaxoSmithKline, Novartis, and Mundipharma; has stock in AKL Ltd; has stock/stock options from AKL Ltd, which produces phytopharmaceuticals; has received payment for travel/accommodations/meeting expenses from Aerocrine, Boehringer Ingelheim, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals (fees paid to Observational and Pragmatic Research Institute); has received funding for patient enrollment or completion of research from Almirral, Chiesi, Teva Pharmaceuticals, Zentiva, and Novartis (fees paid to Observational and Pragmatic Research Institute); is peer reviewer for grant committees of Medical Research Council (2014), Efficacy and Mechanism Evaluation programme (2012), and Health Technology Assessment (HTA) (2014); and owns 80% of Research in Real Life Ltd, 74% of the social enterprise Optimum Patient Care Ltd, UK, and 74% of Observational and Pragmatic Research Institute Pte Ltd, Singapore. M. Román-Rodríguez has received personal fees from Almirall, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Chiesi, Menarini, Mundipharma Research Limited, Novartis, Pfizer, Rovi, Teva, and Gebro and has received research support from personal fees from GlaxoSmithKline. R.B. McQueen was employed by RiRL, which conducted this study and which has conducted paid research in respiratory disease on behalf of the following other organizations in the past 5 years: Aerocrine, AKL Ltd, Almirall, Astra Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma Research Limited, Napp, Novartis, Orion, Sanofi, Takeda, and Teva; has received travel support from the Respiratory Effectiveness Group; has received payment for writing/reviewing the manuscript from Observational and Pragmatic Research Institute; has received consultancy fees from Health Econ Solutions; and is employed by Observational and Pragmatic Research Institute. S. Bosnic-Anticevich is on the advisory boards for Teva Pharmaceuticals and Boehringer Ingelheim; has received research support from Teva; and has received lecture fees from Teva, GlaxoSmithKline, AstraZeneca, and Mundipharma Research Limited. V. Carter is employed by Optimum Patient Care, which conducted this study in collaboration with RiRL and which has conducted paid research in respiratory disease on behalf of the following other organizations in the past 5 years: Aerocrine, AKL Ltd, Almirall, Astra Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma Research Limited, Napp, Novartis, Orion, Sanofi, Takeda, and Teva. K. Gruffydd-Jones has received consultancy and lecture fees from GlaxoSmithKline, AstraZeneca, Mundipharma Research Limited, Boehringer Ingelheim, TEVA, Chiesi, and Pfizer. J. Haughney has received reimbursements for attending symposia, fees for speaking, organizing educational events, funds for research, or fees for consulting from Cipla, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck Sharp & Dohme, Mundipharma Research Limited, Novartis, and Teva. C. Hutton has received research support from Mundipharma Research Limited (fees paid to Observational and Pragmatic Research Institute for research and dissemination); has received consultancy fees from Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma Research Limited, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; is employed by Observational and Pragmatic Research Institute Pte Ltd, which receives funding from UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Eli Lilly, GlaxoSmithKline, Meda, Merck, Mundipharma Research Limited, Napp, Novartis, Orion, Pfizer, Respiratory Effectiveness Group, Takeda, Teva Pharmaceuticals, and Zentiva; has received lecture fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma Research Limited, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; has received payment for manuscript preparation from Mundipharma Research Limited and Teva Pharmaceuticals; has received payment for developing educational presentations from Novartis and Mundipharma Research Limited; has received travel support from Aerocrine, Boehringer Ingelheim, Mundipharma Research Limited, Napp, Novartis, Teva Pharmaceuticals, and AstraZeneca; has received funding for patient enrollment or completion of research from Chiesi, Teva Pharmaceuticals, Zentiva, and Novartis (fees paid to Observational and Pragmatic Research Institute); and was peer reviewer for grant committees of Medical Research Council (2014), Efficacy and Mechanism Evaluation programme (2012), and HTA (2014). F. Lavorini has received in the past 5 years honoraria for consultancy and presentations from the following pharmaceutical companies that market inhaled products: Cipla, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Menarini International, TEVA and Zentiva. L.M. Law declares that her institute, Cambridge Research Support, is part of a network of companies that includes Observational and Pragmatic Research Institute, which receives funding from UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Eli Lilly, GlaxoSmithKline, Meda, Merck, Mundipharma Research Limited, Napp, Novartis, Orion, Pfizer, Respiratory Effectiveness Group, Takeda, Teva Pharmaceuticals, and Zentiva; has received consultancy fees from Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma Research Limited, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; has received lecture fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma Research Limited, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; has received payment for manuscript preparation from Mundipharma Research Limited and Teva Pharmaceuticals; has received payment for the development of educational presentations from Novartis and Mundipharma Research Limited; has received travel support from Aerocrine, Boehringer Ingelheim, Mundipharma Research Limited, Napp, Novartis, Teva Pharmaceuticals, and AstraZeneca; has received funding for patient enrollment or completion of research from Chiesi, Teva Pharmaceuticals, Zentiva, and Novartis (fees paid to Observational and Pragmatic Research Institute); and is peer reviewer for grant committees from Medical Research Council (2014), Efficacy and Mechanism Evaluation programme (2012), and HTA (2014). K. Lisspers is on the boards for Novartis and Meda; is on the scientific committee for AstraZeneca and Novartis; has received lecture fees from AstraZeneca, GlaxoSmithKline, Meda, Nycomed, Boehringer Ingelheim, and Novartis; has received payment for developing educational presentations from Novartis; and is on the steering committees for AstraZeneca and Novartis. A. Papi is on the boards for and has received research and travel support and consultancy and lecture fees from Chiesi Farmaceutici, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Merck Sharp & Dohme, Takeda, Mundipharma Research Limited, and Teva; has received lecture fees and travel support from Menarini, Novartis, and Zambon; is on the boards for and has received lecture fees and research and travel support from Pfizer; and has received research support from Sanofi. D. Ryan has received consultancy fees from Chiesi, Teva, Novartis, and Boehringer Ingelheim; fees for advisory boards from Teva, Chiesi, Boehringer ingelheim, and Novartis; has received lecture fees from Takeda, AstraZeneca, and Meda; has received payment for educational presentations from Meda; is European Academy of Allergy and Clinical Immunology chair of primary care interest group; is Director of Respiratory Effectiveness Group; and is Strategic Clinical Director for Optimum Patient Care. B. Ställberg has received honoraria for educational activities and lectures from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Meda, MSD, Novartis and TEVA, and has served on advisory boards arranged by GlaxoSmithKline, AstraZeneca, Novartis, Meda, and Boehringer Ingelheim. T. van der Molen has received grants for research, travel fees, and reimbursement for presentations and advisory boards from AstraZeneca, GlaxoSmithKline, Almirall, Mundipharma Research Limited, Boehringer Ingelheim, Chiesi, Teva, and Novartis and is on the Certe Laboratories board. Henry Chrystyn has no shares in any pharmaceutical companies; is employed by RiRL, which is subcontracted by Observational and Pragmatic Research Institute Pte Ltd who received fees from Mundipharma Research Limited for this research; has received sponsorship to carry out studies, together with board membership, consultant agreements, and honoraria for presentation from several pharmaceutical companies that market inhaled products. These include Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Innovata Biomed, Meda, Napp Pharmaceuticals, Mundipharma Research Limited, NorPharma, Novartis, Orion, Sanofi, Teva, Truddell Medical International, UCB, and Zentiva. Research sponsorship has also been received from grant awarding bodies (Engineering and Physical Sciences Research Council [EPSRC] and Medical Research Council [MRC]). He owns 50% of Inhalation Consultancy Ltd. The rest of the authors declare that they have no relevant conflicts of interest.

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