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STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study / JOSEPH ANNANDALE

Swansea University Author: JOSEPH ANNANDALE

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Abstract

INTRODUCTIONCurrent clinical guidelines recommend the use of inhaler corticosteroids (ICS) in combination with long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD). Despite their use being recommended in patients who exacerbate frequently, in practice they ar...

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Published: Swansea University, Wales, UK 2024
Institution: Swansea University
Degree level: Master of Research
Degree name: MSc by Research
Supervisor: Lewis, K. E., and Hutchings, H.
URI: https://cronfa.swan.ac.uk/Record/cronfa66145
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fullrecord <?xml version="1.0" encoding="utf-8"?><rfc1807 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xsd="http://www.w3.org/2001/XMLSchema"><bib-version>v2</bib-version><id>66145</id><entry>2024-04-24</entry><title>STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study</title><swanseaauthors><author><sid>2c53df274d8c992f15a2fefd88a6f77e</sid><firstname>JOSEPH</firstname><surname>ANNANDALE</surname><name>JOSEPH ANNANDALE</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2024-04-24</date><abstract>INTRODUCTIONCurrent clinical guidelines recommend the use of inhaler corticosteroids (ICS) in combination with long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD). Despite their use being recommended in patients who exacerbate frequently, in practice they are more broadly prescribed potentially exposing patients to side effects but little or no benefit with a cost burden. Randomised studies with strict inclusion/exclusion criteria have demonstrated it is possible to safely stop an ICS. This feasibility study aimed to test a real-world protocol to stop ICS in patients with stable COPD, despite having the typical exclusion criteria seen in the randomised studies.METHODSStable participants with a confirmed diagnosis of COPD who were prescribed ICS as well as 2 long-acting bronchodilators were recruited. Those with an exacerbation within six weeks, a history of asthma or peripheral blood eosinophil count &gt;600 dl/l were excluded. Participants were shown the four currently licensed dual long-acting bronchodilators combination inhalers and were asked to select one. After confirming effective inhaler technique, they were prescribed the combination inhaler. Participants were free to restart an ICS at any point. Lung function (FEV1) and quality of life scores (CAT) were recorded at baseline, 4 and 52-week visits. Exacerbations urequiring treatment were compared 12 months pre and post inhaler switch. Feasibility was measured using a Model with predefined criteria.RESULTSOf the 10 feasibility criteria 60% were met (participant follow up/completion; data collection, primary care access; cost savings) and 40% not met (recruitment targets; primary care staff participation; numbers completing study not on an ICS; exacerbation rates). 3 participants died within the study period but none attributed to their participation. 57% (n=37) of participants did not restart an ICS and there was no significant rise in exacerbation rates when compared to the 12 months prior to the study (p=0.229). There was an increase in hospital admission rate but still very low from 0.05/year to 0.2/year (p=0.007). There was no significant change in FEV1 (p=0.883) or CAT scores (p=0.662). Overall prescribing cost savings were significant and estimated at &gt;£18K (p=&lt;0.001). Analysis by outcome (those completing study on ICS and those not) demonstrated a clear difference in the 2 groups at baseline with those not restarting an ICS having less exacerbations in the 12 months prior to the study with better lung function and quality of life.DISCUSSIONThe results suggest that overall, the study protocols were safe with the potential to discontinue ICS therapy in some patients. The clear differences within the group at baseline may account for those needing to restart ICS therapy and appears those with more severe disease continued the decline in terms of exacerbations, lung function, quality of life and hospital admissions. These factors could be considered and potentially result in amendments to the study protocol for a future larger study. A larger study would be feasible but recruitment targets would need to be re-evaluated and who delivers the intervention considered, as Primary Care have no capacity to directly support such a study.</abstract><type>E-Thesis</type><journal/><volume/><journalNumber/><paginationStart/><paginationEnd/><publisher/><placeOfPublication>Swansea University, Wales, UK</placeOfPublication><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic/><keywords>COPD, inhaled corticosteroids</keywords><publishedDay>6</publishedDay><publishedMonth>3</publishedMonth><publishedYear>2024</publishedYear><publishedDate>2024-03-06</publishedDate><doi/><url/><notes/><college>COLLEGE NANME</college><CollegeCode>COLLEGE CODE</CollegeCode><institution>Swansea University</institution><supervisor>Lewis, K. E., and Hutchings, H.</supervisor><degreelevel>Master of Research</degreelevel><degreename>MSc by Research</degreename><apcterm/><funders/><projectreference/><lastEdited>2024-05-30T16:53:27.2696751</lastEdited><Created>2024-04-24T10:36:46.6910272</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Biomedical Science</level></path><authors><author><firstname>JOSEPH</firstname><surname>ANNANDALE</surname><order>1</order></author></authors><documents><document><filename>66145__30257__df65994cd6854948b60dfadeedcfc802.pdf</filename><originalFilename>Annandale_Joseph_MRes_Thesis_Final_Redacted_Signatures.pdf</originalFilename><uploaded>2024-05-03T09:26:20.0947268</uploaded><type>Output</type><contentLength>3432166</contentLength><contentType>application/pdf</contentType><version>E-Thesis – open access</version><cronfaStatus>true</cronfaStatus><documentNotes>Copyright: The Author, Joseph Alexander Annandale, 2023.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling v2 66145 2024-04-24 STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study 2c53df274d8c992f15a2fefd88a6f77e JOSEPH ANNANDALE JOSEPH ANNANDALE true false 2024-04-24 INTRODUCTIONCurrent clinical guidelines recommend the use of inhaler corticosteroids (ICS) in combination with long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD). Despite their use being recommended in patients who exacerbate frequently, in practice they are more broadly prescribed potentially exposing patients to side effects but little or no benefit with a cost burden. Randomised studies with strict inclusion/exclusion criteria have demonstrated it is possible to safely stop an ICS. This feasibility study aimed to test a real-world protocol to stop ICS in patients with stable COPD, despite having the typical exclusion criteria seen in the randomised studies.METHODSStable participants with a confirmed diagnosis of COPD who were prescribed ICS as well as 2 long-acting bronchodilators were recruited. Those with an exacerbation within six weeks, a history of asthma or peripheral blood eosinophil count >600 dl/l were excluded. Participants were shown the four currently licensed dual long-acting bronchodilators combination inhalers and were asked to select one. After confirming effective inhaler technique, they were prescribed the combination inhaler. Participants were free to restart an ICS at any point. Lung function (FEV1) and quality of life scores (CAT) were recorded at baseline, 4 and 52-week visits. Exacerbations urequiring treatment were compared 12 months pre and post inhaler switch. Feasibility was measured using a Model with predefined criteria.RESULTSOf the 10 feasibility criteria 60% were met (participant follow up/completion; data collection, primary care access; cost savings) and 40% not met (recruitment targets; primary care staff participation; numbers completing study not on an ICS; exacerbation rates). 3 participants died within the study period but none attributed to their participation. 57% (n=37) of participants did not restart an ICS and there was no significant rise in exacerbation rates when compared to the 12 months prior to the study (p=0.229). There was an increase in hospital admission rate but still very low from 0.05/year to 0.2/year (p=0.007). There was no significant change in FEV1 (p=0.883) or CAT scores (p=0.662). Overall prescribing cost savings were significant and estimated at >£18K (p=<0.001). Analysis by outcome (those completing study on ICS and those not) demonstrated a clear difference in the 2 groups at baseline with those not restarting an ICS having less exacerbations in the 12 months prior to the study with better lung function and quality of life.DISCUSSIONThe results suggest that overall, the study protocols were safe with the potential to discontinue ICS therapy in some patients. The clear differences within the group at baseline may account for those needing to restart ICS therapy and appears those with more severe disease continued the decline in terms of exacerbations, lung function, quality of life and hospital admissions. These factors could be considered and potentially result in amendments to the study protocol for a future larger study. A larger study would be feasible but recruitment targets would need to be re-evaluated and who delivers the intervention considered, as Primary Care have no capacity to directly support such a study. E-Thesis Swansea University, Wales, UK COPD, inhaled corticosteroids 6 3 2024 2024-03-06 COLLEGE NANME COLLEGE CODE Swansea University Lewis, K. E., and Hutchings, H. Master of Research MSc by Research 2024-05-30T16:53:27.2696751 2024-04-24T10:36:46.6910272 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science JOSEPH ANNANDALE 1 66145__30257__df65994cd6854948b60dfadeedcfc802.pdf Annandale_Joseph_MRes_Thesis_Final_Redacted_Signatures.pdf 2024-05-03T09:26:20.0947268 Output 3432166 application/pdf E-Thesis – open access true Copyright: The Author, Joseph Alexander Annandale, 2023. true eng
title STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study
spellingShingle STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study
JOSEPH ANNANDALE
title_short STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study
title_full STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study
title_fullStr STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study
title_full_unstemmed STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study
title_sort STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study
author_id_str_mv 2c53df274d8c992f15a2fefd88a6f77e
author_id_fullname_str_mv 2c53df274d8c992f15a2fefd88a6f77e_***_JOSEPH ANNANDALE
author JOSEPH ANNANDALE
author2 JOSEPH ANNANDALE
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institution Swansea University
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
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description INTRODUCTIONCurrent clinical guidelines recommend the use of inhaler corticosteroids (ICS) in combination with long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD). Despite their use being recommended in patients who exacerbate frequently, in practice they are more broadly prescribed potentially exposing patients to side effects but little or no benefit with a cost burden. Randomised studies with strict inclusion/exclusion criteria have demonstrated it is possible to safely stop an ICS. This feasibility study aimed to test a real-world protocol to stop ICS in patients with stable COPD, despite having the typical exclusion criteria seen in the randomised studies.METHODSStable participants with a confirmed diagnosis of COPD who were prescribed ICS as well as 2 long-acting bronchodilators were recruited. Those with an exacerbation within six weeks, a history of asthma or peripheral blood eosinophil count >600 dl/l were excluded. Participants were shown the four currently licensed dual long-acting bronchodilators combination inhalers and were asked to select one. After confirming effective inhaler technique, they were prescribed the combination inhaler. Participants were free to restart an ICS at any point. Lung function (FEV1) and quality of life scores (CAT) were recorded at baseline, 4 and 52-week visits. Exacerbations urequiring treatment were compared 12 months pre and post inhaler switch. Feasibility was measured using a Model with predefined criteria.RESULTSOf the 10 feasibility criteria 60% were met (participant follow up/completion; data collection, primary care access; cost savings) and 40% not met (recruitment targets; primary care staff participation; numbers completing study not on an ICS; exacerbation rates). 3 participants died within the study period but none attributed to their participation. 57% (n=37) of participants did not restart an ICS and there was no significant rise in exacerbation rates when compared to the 12 months prior to the study (p=0.229). There was an increase in hospital admission rate but still very low from 0.05/year to 0.2/year (p=0.007). There was no significant change in FEV1 (p=0.883) or CAT scores (p=0.662). Overall prescribing cost savings were significant and estimated at >£18K (p=<0.001). Analysis by outcome (those completing study on ICS and those not) demonstrated a clear difference in the 2 groups at baseline with those not restarting an ICS having less exacerbations in the 12 months prior to the study with better lung function and quality of life.DISCUSSIONThe results suggest that overall, the study protocols were safe with the potential to discontinue ICS therapy in some patients. The clear differences within the group at baseline may account for those needing to restart ICS therapy and appears those with more severe disease continued the decline in terms of exacerbations, lung function, quality of life and hospital admissions. These factors could be considered and potentially result in amendments to the study protocol for a future larger study. A larger study would be feasible but recruitment targets would need to be re-evaluated and who delivers the intervention considered, as Primary Care have no capacity to directly support such a study.
published_date 2024-03-06T16:53:27Z
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