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 : 002192 ( Main/Exploration ); précédent : 002191; suivant : 002193Comparison 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 :
- BMC Pulmonary Medicine [ 1471-2466 ] ; 2016.
Descripteurs français
- KwdFr :
- Administration par inhalation, Adulte, Adulte d'âge moyen, Agonistes bêta-adrénergiques (administration et posologie), Asthme (traitement médicamenteux), Broncho-pneumopathie chronique obstructive (traitement médicamenteux), Conception d'appareillage, Femelle, Hormones corticosurrénaliennes (administration et posologie), Humains, Inhalateurs à poudre sèche, Mâle, Odds ratio, Sujet âgé, Études croisées.
- MESH :
- administration et posologie : Agonistes bêta-adrénergiques, Hormones corticosurrénaliennes.
- traitement médicamenteux : Asthme, Broncho-pneumopathie chronique obstructive.
- Administration par inhalation, Adulte, Adulte d'âge moyen, Conception d'appareillage, Femelle, Humains, Inhalateurs à poudre sèche, Mâle, Odds ratio, Sujet âgé, Études croisées.
English descriptors
- KwdEn :
- Administration, Inhalation, Adrenal Cortex Hormones (administration & dosage), Adrenergic beta-Agonists (administration & dosage), Adult, Aged, Asthma (drug therapy), Cross-Over Studies, Dry Powder Inhalers, Equipment Design, Female, Humans, Male, Middle Aged, Odds Ratio, Pulmonary Disease, Chronic Obstructive (drug therapy).
- MESH :
- chemical , administration & dosage : Adrenal Cortex Hormones, Adrenergic beta-Agonists.
- drug therapy : Asthma, Pulmonary Disease, Chronic Obstructive.
- Administration, Inhalation, Adult, Aged, Cross-Over Studies, Dry Powder Inhalers, Equipment Design, Female, Humans, Male, Middle Aged, Odds Ratio.
Abstract
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.
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.
Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (
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.
ClinicalTrials.gov Identifier:
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
Affiliations:
- Australie, France, Italie, Royaume-Uni
- Angleterre, Aquitaine, Nouvelle-Aquitaine, Nouvelle-Galles du Sud, Oxfordshire, Île-de-France
- Bordeaux, Oxford, Paris, Sydney
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Le document en format XML
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three different dry powder inhalers: a randomised, crossover, open-label study</title><author><name sortKey="Chrystyn, Henry" sort="Chrystyn, Henry" uniqKey="Chrystyn H" first="Henry" last="Chrystyn">Henry Chrystyn</name><affiliation><nlm:aff id="Aff1">Inhalation Consultancy Ltd, Yeadon, Leeds, West Yorkshire UK</nlm:aff><wicri:noCountry code="subfield">West Yorkshire UK</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research in Real-Life, 5a Coles Lane, Oakington, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Price, David B" sort="Price, David B" uniqKey="Price D" first="David B." last="Price">David B. Price</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research in Real-Life, 5a Coles Lane, Oakington, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation><affiliation><nlm:aff id="Aff3">Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD UK</nlm:aff><wicri:noCountry code="subfield">AB25 2ZD UK</wicri:noCountry></affiliation></author><author><name sortKey="Molimard, Mathieu" sort="Molimard, Mathieu" uniqKey="Molimard M" first="Mathieu" last="Molimard">Mathieu Molimard</name><affiliation wicri:level="3"><nlm:aff id="Aff4">Department of Medical Pharmacology, CHU et Univ. de Bordeaux, Bordeaux, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Medical Pharmacology, CHU et Univ. de Bordeaux, Bordeaux</wicri:regionArea><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Aquitaine</region><settlement type="city">Bordeaux</settlement></placeName></affiliation></author><author><name sortKey="Haughney, John" sort="Haughney, John" uniqKey="Haughney J" first="John" last="Haughney">John Haughney</name><affiliation><nlm:aff id="Aff3">Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD UK</nlm:aff><wicri:noCountry code="subfield">AB25 2ZD UK</wicri:noCountry></affiliation></author><author><name sortKey="Bosnic Anticevich, Sinthia" sort="Bosnic Anticevich, Sinthia" uniqKey="Bosnic Anticevich S" first="Sinthia" last="Bosnic-Anticevich">Sinthia Bosnic-Anticevich</name><affiliation wicri:level="3"><nlm:aff id="Aff5">Woolcock Institute of Medical Research, Sydney Medical School, University of Sydney and Sydney Local Health District, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Woolcock Institute of Medical Research, Sydney Medical School, University of Sydney and Sydney Local Health District, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Lavorini, Federico" sort="Lavorini, Federico" uniqKey="Lavorini F" first="Federico" last="Lavorini">Federico Lavorini</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence</wicri:regionArea><wicri:noRegion>Florence</wicri:noRegion></affiliation></author><author><name sortKey="Efthimiou, John" sort="Efthimiou, John" uniqKey="Efthimiou J" first="John" last="Efthimiou">John Efthimiou</name><affiliation wicri:level="3"><nlm:aff id="Aff7">Horizon Respiratory Consultancy, Oxford, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Horizon Respiratory Consultancy, Oxford</wicri:regionArea><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region></placeName></affiliation></author><author><name sortKey="Shan, Dawn" sort="Shan, Dawn" uniqKey="Shan D" first="Dawn" last="Shan">Dawn Shan</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research in Real-Life, 5a Coles Lane, Oakington, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Sims, Erika" sort="Sims, Erika" uniqKey="Sims E" first="Erika" last="Sims">Erika Sims</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research in Real-Life, 5a Coles Lane, Oakington, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff8">Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich</wicri:regionArea><wicri:noRegion>Norwich</wicri:noRegion></affiliation></author><author><name sortKey="Burden, Anne" sort="Burden, Anne" uniqKey="Burden A" first="Anne" last="Burden">Anne Burden</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research in Real-Life, 5a Coles Lane, Oakington, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Hutton, Catherine" sort="Hutton, Catherine" uniqKey="Hutton C" first="Catherine" last="Hutton">Catherine Hutton</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Research in Real-Life, 5a Coles Lane, Oakington, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Roche, Nicolas" sort="Roche, Nicolas" uniqKey="Roche N" first="Nicolas" last="Roche">Nicolas Roche</name><affiliation wicri:level="3"><nlm:aff id="Aff9">University Paris Descartes (EA2511), Respiratory and Intensive Care Medicine Department, Cochin Hospital Group, AP-HP, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>University Paris Descartes (EA2511), Respiratory and Intensive Care Medicine Department, Cochin Hospital Group, AP-HP, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></analytic><series><title level="j">BMC Pulmonary Medicine</title><idno type="eISSN">1471-2466</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Inhalation</term><term>Adrenal Cortex Hormones (administration & dosage)</term><term>Adrenergic beta-Agonists (administration & dosage)</term><term>Adult</term><term>Aged</term><term>Asthma (drug therapy)</term><term>Cross-Over Studies</term><term>Dry Powder Inhalers</term><term>Equipment Design</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Odds Ratio</term><term>Pulmonary Disease, Chronic Obstructive (drug therapy)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Administration par inhalation</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Agonistes bêta-adrénergiques (administration et posologie)</term><term>Asthme (traitement médicamenteux)</term><term>Broncho-pneumopathie chronique obstructive (traitement médicamenteux)</term><term>Conception d'appareillage</term><term>Femelle</term><term>Hormones corticosurrénaliennes (administration et posologie)</term><term>Humains</term><term>Inhalateurs à poudre sèche</term><term>Mâle</term><term>Odds ratio</term><term>Sujet âgé</term><term>Études croisées</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adrenal Cortex Hormones</term><term>Adrenergic beta-Agonists</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Agonistes bêta-adrénergiques</term><term>Hormones corticosurrénaliennes</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Asthma</term><term>Pulmonary Disease, Chronic Obstructive</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Asthme</term><term>Broncho-pneumopathie chronique obstructive</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Inhalation</term><term>Adult</term><term>Aged</term><term>Cross-Over Studies</term><term>Dry Powder Inhalers</term><term>Equipment Design</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Odds Ratio</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Administration par inhalation</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Conception d'appareillage</term><term>Femelle</term><term>Humains</term><term>Inhalateurs à poudre sèche</term><term>Mâle</term><term>Odds ratio</term><term>Sujet âgé</term><term>Études croisées</term></keywords></textClass></profileDesc></teiHeader><front><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></sec></div></front><back><div1 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Diot</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>Italie</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Aquitaine</li><li>Nouvelle-Aquitaine</li><li>Nouvelle-Galles du Sud</li><li>Oxfordshire</li><li>Île-de-France</li></region><settlement><li>Bordeaux</li><li>Oxford</li><li>Paris</li><li>Sydney</li></settlement></list><tree><noCountry><name sortKey="Haughney, John" sort="Haughney, John" uniqKey="Haughney J" first="John" last="Haughney">John Haughney</name></noCountry><country name="Royaume-Uni"><noRegion><name sortKey="Chrystyn, Henry" sort="Chrystyn, Henry" uniqKey="Chrystyn H" first="Henry" last="Chrystyn">Henry Chrystyn</name></noRegion><name sortKey="Burden, Anne" sort="Burden, Anne" uniqKey="Burden A" first="Anne" last="Burden">Anne Burden</name><name sortKey="Efthimiou, John" sort="Efthimiou, John" uniqKey="Efthimiou J" first="John" last="Efthimiou">John 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Price</name><name sortKey="Shan, Dawn" sort="Shan, Dawn" uniqKey="Shan D" first="Dawn" last="Shan">Dawn Shan</name><name sortKey="Sims, Erika" sort="Sims, Erika" uniqKey="Sims E" first="Erika" last="Sims">Erika Sims</name><name sortKey="Sims, Erika" sort="Sims, Erika" uniqKey="Sims E" first="Erika" last="Sims">Erika Sims</name></country><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Molimard, Mathieu" sort="Molimard, Mathieu" uniqKey="Molimard M" first="Mathieu" last="Molimard">Mathieu Molimard</name></region><name sortKey="Roche, Nicolas" sort="Roche, Nicolas" uniqKey="Roche N" first="Nicolas" last="Roche">Nicolas Roche</name></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Bosnic Anticevich, Sinthia" sort="Bosnic Anticevich, Sinthia" uniqKey="Bosnic Anticevich S" first="Sinthia" last="Bosnic-Anticevich">Sinthia Bosnic-Anticevich</name></region></country><country name="Italie"><noRegion><name sortKey="Lavorini, Federico" sort="Lavorini, Federico" uniqKey="Lavorini F" first="Federico" last="Lavorini">Federico Lavorini</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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