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

Research output: Contribution to journalArticle

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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 languageEnglish
Article number12
Pages (from-to)1-14
Number of pages14
JournalBMC Pulmonary Medicine
Volume16
Issue number1
DOIs
Publication statusPublished - 14 Jan 2016

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Dry Powder Inhalers
Nebulizers and Vaporizers
Equipment and Supplies
Nurses
Inhalation
Reading
Random Allocation
Chronic Obstructive Pulmonary Disease
Asthma
Odds Ratio
Lung

Keywords

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

Cite this

Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers : a randomised, crossover, open-label study. / Chrystyn, Henry; Price, David B.; Molimard, Mathieu; Haughney, John; Bosnic-Anticevich, Sinthia; Lavorini, Federico; Efthimiou, John; Shan, Dawn; Sims, Erika; Burden, Anne; Hutton, Catherine; Roche, Nicolas.

In: BMC Pulmonary Medicine, Vol. 16, No. 1, 12, 14.01.2016, p. 1-14.

Research output: Contribution to journalArticle

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
Chrystyn, Henry ; Price, David B. ; Molimard, Mathieu ; Haughney, John ; Bosnic-Anticevich, Sinthia ; Lavorini, Federico ; Efthimiou, John ; Shan, Dawn ; Sims, Erika ; Burden, Anne ; Hutton, Catherine ; Roche, Nicolas. / Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers : a randomised, crossover, open-label study. In: BMC Pulmonary Medicine. 2016 ; Vol. 16, No. 1. pp. 1-14.
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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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T1 - Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers

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.

PY - 2016/1/14

Y1 - 2016/1/14

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).

KW - Asthma

KW - Chronic obstructive pulmonary disease

KW - Serious errors

KW - Dry powder inhaler

KW - Inhaler technique

KW - Mastery

U2 - 10.1186/s12890-016-0169-5

DO - 10.1186/s12890-016-0169-5

M3 - Article

VL - 16

SP - 1

EP - 14

JO - BMC Pulmonary Medicine

JF - BMC Pulmonary Medicine

SN - 1471-2466

IS - 1

M1 - 12

ER -