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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

Identifieur interne : 000B06 ( Pmc/Curation ); précédent : 000B05; suivant : 000B07

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

Auteurs : Henry Chrystyn [Royaume-Uni] ; David B. Price [Royaume-Uni] ; Mathieu Molimard [France] ; John Haughney ; Sinthia Bosnic-Anticevich [Australie] ; Federico Lavorini [Italie] ; John Efthimiou [Royaume-Uni] ; Dawn Shan [Royaume-Uni] ; Erika Sims [Royaume-Uni] ; Anne Burden [Royaume-Uni] ; Catherine Hutton [Royaume-Uni] ; Nicolas Roche [France]

Source :

RBID : PMC:4712500

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)

Electronic supplementary material

The online version of this article (doi:10.1186/s12890-016-0169-5) contains supplementary material, which is available to authorized users.


Url:
DOI: 10.1186/s12890-016-0169-5
PubMed: 26769482
PubMed Central: 4712500

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PMC:4712500

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Henry Chrystyn
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David B. Price
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John Haughney
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<div type="abstract" xml:lang="en">
<sec>
<title>Background</title>
<p>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.</p>
</sec>
<sec>
<title>Methods</title>
<p>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.</p>
</sec>
<sec>
<title>Results</title>
<p>Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (
<italic>n</italic>
 = 277) and Pulmojet-Turbohaler (
<italic>n</italic>
 = 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.</p>
</sec>
<sec>
<title>Conclusions</title>
<p>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.</p>
</sec>
<sec>
<title>Trial registration</title>
<p>ClinicalTrials.gov Identifier:
<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01794390">NCT01794390 </ext-link>
(February 14, 2013)</p>
</sec>
<sec>
<title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12890-016-0169-5) contains supplementary material, which is available to authorized users.</p>
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<journal-id journal-id-type="nlm-ta">BMC Pulm Med</journal-id>
<journal-id journal-id-type="iso-abbrev">BMC Pulm Med</journal-id>
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<journal-title>BMC Pulmonary Medicine</journal-title>
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<issn pub-type="epub">1471-2466</issn>
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<publisher-name>BioMed Central</publisher-name>
<publisher-loc>London</publisher-loc>
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</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">26769482</article-id>
<article-id pub-id-type="pmc">4712500</article-id>
<article-id pub-id-type="publisher-id">169</article-id>
<article-id pub-id-type="doi">10.1186/s12890-016-0169-5</article-id>
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<subj-group subj-group-type="heading">
<subject>Research Article</subject>
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<title-group>
<article-title>Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study</article-title>
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<xref ref-type="aff" rid="Aff2"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hutton</surname>
<given-names>Catherine</given-names>
</name>
<address>
<email>catherine@rirl.org</email>
</address>
<xref ref-type="aff" rid="Aff2"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Roche</surname>
<given-names>Nicolas</given-names>
</name>
<address>
<email>nicolas.roche@cch.aphp.fr</email>
</address>
<xref ref-type="aff" rid="Aff9"></xref>
</contrib>
<aff id="Aff1">
<label></label>
Inhalation Consultancy Ltd, Yeadon, Leeds, West Yorkshire UK</aff>
<aff id="Aff2">
<label></label>
Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK</aff>
<aff id="Aff3">
<label></label>
Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD UK</aff>
<aff id="Aff4">
<label></label>
Department of Medical Pharmacology, CHU et Univ. de Bordeaux, Bordeaux, France</aff>
<aff id="Aff5">
<label></label>
Woolcock Institute of Medical Research, Sydney Medical School, University of Sydney and Sydney Local Health District, Sydney, Australia</aff>
<aff id="Aff6">
<label></label>
Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence, Italy</aff>
<aff id="Aff7">
<label></label>
Horizon Respiratory Consultancy, Oxford, UK</aff>
<aff id="Aff8">
<label></label>
Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK</aff>
<aff id="Aff9">
<label></label>
University Paris Descartes (EA2511), Respiratory and Intensive Care Medicine Department, Cochin Hospital Group, AP-HP, Paris, France</aff>
</contrib-group>
<pub-date pub-type="epub">
<day>14</day>
<month>1</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>14</day>
<month>1</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="collection">
<year>2016</year>
</pub-date>
<volume>16</volume>
<elocation-id>12</elocation-id>
<history>
<date date-type="received">
<day>13</day>
<month>5</month>
<year>2015</year>
</date>
<date date-type="accepted">
<day>5</day>
<month>1</month>
<year>2016</year>
</date>
</history>
<permissions>
<copyright-statement>© Chrystyn et al. 2016</copyright-statement>
<license license-type="OpenAccess">
<license-p>
<bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (
<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
), 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 (
<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>
) applies to the data made available in this article, unless otherwise stated.</license-p>
</license>
</permissions>
<abstract id="Abs1">
<sec>
<title>Background</title>
<p>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.</p>
</sec>
<sec>
<title>Methods</title>
<p>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.</p>
</sec>
<sec>
<title>Results</title>
<p>Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (
<italic>n</italic>
 = 277) and Pulmojet-Turbohaler (
<italic>n</italic>
 = 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.</p>
</sec>
<sec>
<title>Conclusions</title>
<p>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.</p>
</sec>
<sec>
<title>Trial registration</title>
<p>ClinicalTrials.gov Identifier:
<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01794390">NCT01794390 </ext-link>
(February 14, 2013)</p>
</sec>
<sec>
<title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12890-016-0169-5) contains supplementary material, which is available to authorized users.</p>
</sec>
</abstract>
<kwd-group xml:lang="en">
<title>Keywords</title>
<kwd>Asthma</kwd>
<kwd>Chronic obstructive pulmonary disease</kwd>
<kwd>Serious errors</kwd>
<kwd>Dry powder inhaler</kwd>
<kwd>Inhaler technique</kwd>
<kwd>Mastery</kwd>
</kwd-group>
<custom-meta-group>
<custom-meta>
<meta-name>issue-copyright-statement</meta-name>
<meta-value>© The Author(s) 2016</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
</record>

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