Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study

Henry Chrystyn; David B. Price; Mathieu Molimard; John Haughney; Sinthia Bosnic-Anticevich; Federico Lavorini; John Efthimiou; Dawn Shan; Erika Sims; Anne Burden; Catherine Hutton; Nicolas Roche

doi:10.1186/s12890-016-0169-5

Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study

Henry Chrystyn, David B. Price, Mathieu Molimard, John Haughney, Sinthia Bosnic-Anticevich, Federico Lavorini, John Efthimiou, Dawn Shan, Erika Sims, Anne Burden, Catherine Hutton, Nicolas Roche

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Abstract

BACKGROUND: Serious inhaler technique errors can impair drug delivery to the lungs. This randomised, crossover, open-label study evaluated the proportion of patients making predefined serious errors with Pulmojet compared with Diskus and Turbohaler dry powder inhalers.

METHODS: Patients ≥18 years old with asthma and/or COPD who were current users of an inhaler but naïve to the study devices were assigned to inhaler technique assessment on Pulmojet and either Diskus or Turbohaler in a randomised order. Patients inhaled through empty devices after reading the patient information leaflet. If serious errors potentially affecting dose delivery were recorded, they repeated the inhalations after watching a training video. Inhaler technique was assessed by a trained nurse observer and an electronic inhalation profile recorder.

RESULTS: Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (n = 277) and Pulmojet-Turbohaler (n = 144) comparisons. Non-inferiority in the proportions of patients recording no nurse-observed serious errors was demonstrated for both Pulmojet versus Diskus, and Pulmojet versus Turbohaler; therefore, superiority was tested. Patients were significantly less likely to make ≥1 nurse-observed serious errors using Pulmojet compared with Diskus (odds ratio, 0.31; 95 % CI, 0.19-0.51) or Pulmojet compared with Turbohaler (0.23; 0.12-0.44) after reading the patient information leaflet with additional video instruction, if required.

CONCLUSIONS: These results suggest Pulmojet is easier to learn to use correctly than the Turbohaler or Diskus for current inhaler users switching to a new dry powder inhaler.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01794390 (February 14, 2013).

Original language	English
Article number	12
Pages (from-to)	1-14
Number of pages	14
Journal	BMC Pulmonary Medicine
Volume	16
Issue number	1
DOIs	https://doi.org/10.1186/s12890-016-0169-5
Publication status	Published - 14 Jan 2016

Bibliographical note

Acknowledgments
We thank Sandra Kreuzaler, Clinical Studies Lead, and Anu Kemppinen for their assistance in coordinating the study. We are grateful to the Principal Investigators and staff at the study sites (listed in Additional file 3) for their contributions to the study. We acknowledge Adam Brady for development and preparation of the randomisation programme and study electronic case report form. Medical writing and editorial assistance was provided by Elizabeth V. Hillyer, DVM, ELS, Consultant to Research in Real-Life, and by Delia Randall, PhD, supported by Research in Real-Life.

Keywords

Asthma
Chronic obstructive pulmonary disease
Serious errors
Dry powder inhaler
Inhaler technique
Mastery

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10.1186/s12890-016-0169-5Licence: CC BY

Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers
© 2016 Chrystyn et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
Final published version, 1.53 MBLicence: CC BY

Cite this

Chrystyn, H., Price, D. B., Molimard, M., Haughney, J., Bosnic-Anticevich, S., Lavorini, F., Efthimiou, J., Shan, D., Sims, E., Burden, A., Hutton, C., & Roche, N. (2016). Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study. BMC Pulmonary Medicine, 16(1), 1-14. Article 12. https://doi.org/10.1186/s12890-016-0169-5

Chrystyn, H, Price, DB, Molimard, M, Haughney, J, Bosnic-Anticevich, S, Lavorini, F, Efthimiou, J, Shan, D, Sims, E, Burden, A, Hutton, C & Roche, N 2016, 'Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study', BMC Pulmonary Medicine, vol. 16, no. 1, 12, pp. 1-14. https://doi.org/10.1186/s12890-016-0169-5

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abstract = "BACKGROUND: Serious inhaler technique errors can impair drug delivery to the lungs. This randomised, crossover, open-label study evaluated the proportion of patients making predefined serious errors with Pulmojet compared with Diskus and Turbohaler dry powder inhalers.METHODS: Patients ≥18 years old with asthma and/or COPD who were current users of an inhaler but na{\"i}ve to the study devices were assigned to inhaler technique assessment on Pulmojet and either Diskus or Turbohaler in a randomised order. Patients inhaled through empty devices after reading the patient information leaflet. If serious errors potentially affecting dose delivery were recorded, they repeated the inhalations after watching a training video. Inhaler technique was assessed by a trained nurse observer and an electronic inhalation profile recorder.RESULTS: Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (n = 277) and Pulmojet-Turbohaler (n = 144) comparisons. Non-inferiority in the proportions of patients recording no nurse-observed serious errors was demonstrated for both Pulmojet versus Diskus, and Pulmojet versus Turbohaler; therefore, superiority was tested. Patients were significantly less likely to make ≥1 nurse-observed serious errors using Pulmojet compared with Diskus (odds ratio, 0.31; 95 % CI, 0.19-0.51) or Pulmojet compared with Turbohaler (0.23; 0.12-0.44) after reading the patient information leaflet with additional video instruction, if required.CONCLUSIONS: These results suggest Pulmojet is easier to learn to use correctly than the Turbohaler or Diskus for current inhaler users switching to a new dry powder inhaler.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01794390 (February 14, 2013).",

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author = "Henry Chrystyn and Price, {David B.} and Mathieu Molimard and John Haughney and Sinthia Bosnic-Anticevich and Federico Lavorini and John Efthimiou and Dawn Shan and Erika Sims and Anne Burden and Catherine Hutton and Nicolas Roche",

note = "Acknowledgments We thank Sandra Kreuzaler, Clinical Studies Lead, and Anu Kemppinen for their assistance in coordinating the study. We are grateful to the Principal Investigators and staff at the study sites (listed in Additional file 3) for their contributions to the study. We acknowledge Adam Brady for development and preparation of the randomisation programme and study electronic case report form. Medical writing and editorial assistance was provided by Elizabeth V. Hillyer, DVM, ELS, Consultant to Research in Real-Life, and by Delia Randall, PhD, supported by Research in Real-Life.",

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T2 - a randomised, crossover, open-label study

AU - Chrystyn, Henry

AU - Price, David B.

AU - Molimard, Mathieu

AU - Haughney, John

AU - Bosnic-Anticevich, Sinthia

AU - Lavorini, Federico

AU - Efthimiou, John

AU - Shan, Dawn

AU - Sims, Erika

AU - Burden, Anne

AU - Hutton, Catherine

AU - Roche, Nicolas

N1 - Acknowledgments We thank Sandra Kreuzaler, Clinical Studies Lead, and Anu Kemppinen for their assistance in coordinating the study. We are grateful to the Principal Investigators and staff at the study sites (listed in Additional file 3) for their contributions to the study. We acknowledge Adam Brady for development and preparation of the randomisation programme and study electronic case report form. Medical writing and editorial assistance was provided by Elizabeth V. Hillyer, DVM, ELS, Consultant to Research in Real-Life, and by Delia Randall, PhD, supported by Research in Real-Life.

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N2 - BACKGROUND: Serious inhaler technique errors can impair drug delivery to the lungs. This randomised, crossover, open-label study evaluated the proportion of patients making predefined serious errors with Pulmojet compared with Diskus and Turbohaler dry powder inhalers.METHODS: Patients ≥18 years old with asthma and/or COPD who were current users of an inhaler but naïve to the study devices were assigned to inhaler technique assessment on Pulmojet and either Diskus or Turbohaler in a randomised order. Patients inhaled through empty devices after reading the patient information leaflet. If serious errors potentially affecting dose delivery were recorded, they repeated the inhalations after watching a training video. Inhaler technique was assessed by a trained nurse observer and an electronic inhalation profile recorder.RESULTS: Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (n = 277) and Pulmojet-Turbohaler (n = 144) comparisons. Non-inferiority in the proportions of patients recording no nurse-observed serious errors was demonstrated for both Pulmojet versus Diskus, and Pulmojet versus Turbohaler; therefore, superiority was tested. Patients were significantly less likely to make ≥1 nurse-observed serious errors using Pulmojet compared with Diskus (odds ratio, 0.31; 95 % CI, 0.19-0.51) or Pulmojet compared with Turbohaler (0.23; 0.12-0.44) after reading the patient information leaflet with additional video instruction, if required.CONCLUSIONS: These results suggest Pulmojet is easier to learn to use correctly than the Turbohaler or Diskus for current inhaler users switching to a new dry powder inhaler.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01794390 (February 14, 2013).

AB - BACKGROUND: Serious inhaler technique errors can impair drug delivery to the lungs. This randomised, crossover, open-label study evaluated the proportion of patients making predefined serious errors with Pulmojet compared with Diskus and Turbohaler dry powder inhalers.METHODS: Patients ≥18 years old with asthma and/or COPD who were current users of an inhaler but naïve to the study devices were assigned to inhaler technique assessment on Pulmojet and either Diskus or Turbohaler in a randomised order. Patients inhaled through empty devices after reading the patient information leaflet. If serious errors potentially affecting dose delivery were recorded, they repeated the inhalations after watching a training video. Inhaler technique was assessed by a trained nurse observer and an electronic inhalation profile recorder.RESULTS: Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (n = 277) and Pulmojet-Turbohaler (n = 144) comparisons. Non-inferiority in the proportions of patients recording no nurse-observed serious errors was demonstrated for both Pulmojet versus Diskus, and Pulmojet versus Turbohaler; therefore, superiority was tested. Patients were significantly less likely to make ≥1 nurse-observed serious errors using Pulmojet compared with Diskus (odds ratio, 0.31; 95 % CI, 0.19-0.51) or Pulmojet compared with Turbohaler (0.23; 0.12-0.44) after reading the patient information leaflet with additional video instruction, if required.CONCLUSIONS: These results suggest Pulmojet is easier to learn to use correctly than the Turbohaler or Diskus for current inhaler users switching to a new dry powder inhaler.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01794390 (February 14, 2013).

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Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study

Abstract

Bibliographical note

Keywords

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