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Improvement in health status with once-daily indacaterol/glycopyrronium 110/50 μg in COPD patients: real-world evidence from an observational study in Ireland

Aims Indacaterol/glycopyrronium (IND/GLY) 110/50 μg is a once-daily (o.d.) fixed-dose combination of long-acting β 2 -agonist/long-acting muscarinic antagonist approved in over 90 countries, including Ireland, for the management of COPD. The present study was conducted to evaluate health status of C...

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Published in:Irish journal of medical science 2019-11, Vol.188 (4), p.1251-1259
Main Authors: O’Doherty, Brian, Dorman, Jane, McGrath, Karen, Kelly, Kevin, Molony, David, Lacey, Seán, Whelan, Sarah, Schmid, Simon, Sullivan, Shane
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container_issue 4
container_start_page 1251
container_title Irish journal of medical science
container_volume 188
creator O’Doherty, Brian
Dorman, Jane
McGrath, Karen
Kelly, Kevin
Molony, David
Lacey, Seán
Whelan, Sarah
Schmid, Simon
Sullivan, Shane
description Aims Indacaterol/glycopyrronium (IND/GLY) 110/50 μg is a once-daily (o.d.) fixed-dose combination of long-acting β 2 -agonist/long-acting muscarinic antagonist approved in over 90 countries, including Ireland, for the management of COPD. The present study was conducted to evaluate health status of COPD patients, initiated on IND/GLY 110/50 μg o.d., using the Clinical COPD Questionnaire (CCQ) tool in a real-world primary care setting in Ireland. Methods This was a real-world, prospective, open-label study. COPD patients aged > 40 years and with a smoking history of > 10 pack-years were included and switched to once-daily IND/GLY 110/50 μg. Enrolment of patients into the study occurred only after the decision had been made by the physician to prescribe IND/GLY 110/50 μg. Data were collected at baseline and Week 26. Health status was assessed using the validated CCQ. Results A total of 200 patients were included in study. The mean CCQ total score decreased from 2.36 at baseline to 1.44 at Week 26 (Δ, 0.92; P  
doi_str_mv 10.1007/s11845-019-02001-y
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The present study was conducted to evaluate health status of COPD patients, initiated on IND/GLY 110/50 μg o.d., using the Clinical COPD Questionnaire (CCQ) tool in a real-world primary care setting in Ireland. Methods This was a real-world, prospective, open-label study. COPD patients aged &gt; 40 years and with a smoking history of &gt; 10 pack-years were included and switched to once-daily IND/GLY 110/50 μg. Enrolment of patients into the study occurred only after the decision had been made by the physician to prescribe IND/GLY 110/50 μg. Data were collected at baseline and Week 26. Health status was assessed using the validated CCQ. Results A total of 200 patients were included in study. The mean CCQ total score decreased from 2.36 at baseline to 1.44 at Week 26 (Δ, 0.92; P  &lt; 0.0005). Of the 156 patients who completed study, 113 (72.4%) achieved minimum clinically important difference in CCQ total score with IND/GLY 110/50 μg. CCQ domain scores also decreased during the study. Improvement in health status was observed across all GOLD groups and irrespective of prior COPD treatment. Adverse events were reported by 20% of patients with COPD exacerbation/infected COPD being the most common AE, reported by 11 patients. Conclusions In real-life clinical practice in Ireland, IND/GLY 110/50 μg o.d. demonstrated statistically significant and clinically important improvement in health status in patients with COPD.</description><identifier>ISSN: 0021-1265</identifier><identifier>EISSN: 1863-4362</identifier><identifier>DOI: 10.1007/s11845-019-02001-y</identifier><identifier>PMID: 30924006</identifier><language>eng</language><publisher>London: Springer London</publisher><subject><![CDATA[Adrenergic beta-2 Receptor Agonists - administration & dosage ; Adult ; Aged ; Aged, 80 and over ; Bronchodilator Agents - administration & dosage ; Family Medicine ; Female ; General Practice ; Glycopyrrolate - administration & dosage ; Health Status ; Humans ; Indans - administration & dosage ; Internal Medicine ; Ireland ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Muscarinic Antagonists - administration & dosage ; Original Article ; Prospective Studies ; Pulmonary Disease, Chronic Obstructive - drug therapy ; Quinolones - administration & dosage ; Severity of Illness Index ; Surveys and Questionnaires ; Treatment Outcome]]></subject><ispartof>Irish journal of medical science, 2019-11, Vol.188 (4), p.1251-1259</ispartof><rights>The Author(s) 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c391t-b282c8bfa6a16bc005033732653f15eca6b1e3234bf1968dc395afa5d4493a313</citedby><cites>FETCH-LOGICAL-c391t-b282c8bfa6a16bc005033732653f15eca6b1e3234bf1968dc395afa5d4493a313</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30924006$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>O’Doherty, Brian</creatorcontrib><creatorcontrib>Dorman, Jane</creatorcontrib><creatorcontrib>McGrath, Karen</creatorcontrib><creatorcontrib>Kelly, Kevin</creatorcontrib><creatorcontrib>Molony, David</creatorcontrib><creatorcontrib>Lacey, Seán</creatorcontrib><creatorcontrib>Whelan, Sarah</creatorcontrib><creatorcontrib>Schmid, Simon</creatorcontrib><creatorcontrib>Sullivan, Shane</creatorcontrib><title>Improvement in health status with once-daily indacaterol/glycopyrronium 110/50 μg in COPD patients: real-world evidence from an observational study in Ireland</title><title>Irish journal of medical science</title><addtitle>Ir J Med Sci</addtitle><addtitle>Ir J Med Sci</addtitle><description>Aims Indacaterol/glycopyrronium (IND/GLY) 110/50 μg is a once-daily (o.d.) fixed-dose combination of long-acting β 2 -agonist/long-acting muscarinic antagonist approved in over 90 countries, including Ireland, for the management of COPD. The present study was conducted to evaluate health status of COPD patients, initiated on IND/GLY 110/50 μg o.d., using the Clinical COPD Questionnaire (CCQ) tool in a real-world primary care setting in Ireland. Methods This was a real-world, prospective, open-label study. COPD patients aged &gt; 40 years and with a smoking history of &gt; 10 pack-years were included and switched to once-daily IND/GLY 110/50 μg. Enrolment of patients into the study occurred only after the decision had been made by the physician to prescribe IND/GLY 110/50 μg. Data were collected at baseline and Week 26. Health status was assessed using the validated CCQ. Results A total of 200 patients were included in study. The mean CCQ total score decreased from 2.36 at baseline to 1.44 at Week 26 (Δ, 0.92; P  &lt; 0.0005). Of the 156 patients who completed study, 113 (72.4%) achieved minimum clinically important difference in CCQ total score with IND/GLY 110/50 μg. CCQ domain scores also decreased during the study. Improvement in health status was observed across all GOLD groups and irrespective of prior COPD treatment. Adverse events were reported by 20% of patients with COPD exacerbation/infected COPD being the most common AE, reported by 11 patients. Conclusions In real-life clinical practice in Ireland, IND/GLY 110/50 μg o.d. demonstrated statistically significant and clinically important improvement in health status in patients with COPD.</description><subject>Adrenergic beta-2 Receptor Agonists - administration &amp; dosage</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Bronchodilator Agents - administration &amp; dosage</subject><subject>Family Medicine</subject><subject>Female</subject><subject>General Practice</subject><subject>Glycopyrrolate - administration &amp; dosage</subject><subject>Health Status</subject><subject>Humans</subject><subject>Indans - administration &amp; dosage</subject><subject>Internal Medicine</subject><subject>Ireland</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Muscarinic Antagonists - administration &amp; dosage</subject><subject>Original Article</subject><subject>Prospective Studies</subject><subject>Pulmonary Disease, Chronic Obstructive - drug therapy</subject><subject>Quinolones - administration &amp; dosage</subject><subject>Severity of Illness Index</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><issn>0021-1265</issn><issn>1863-4362</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp9kU2O1DAQhS0EYpqBC7BAXrIxXWUn7oQdav5aGmlYwNpynEpPRk7c2EmPcps5CCsOwJlw0wNLVrbk974qv8fYS4Q3CLBZJ8SqKAVgLUACoFgesRVWWolCafmYrQAkCpS6vGDPUroFULXSxVN2oaCWBYBesfvdcIjhSAONE-9HfkPWTzc8TXaaE7_r8z2MjkRre79kQWudnSgGv977xYXDEmMY-3ngiLAu4ef9rx_7E2d7_eU9P9ipz9z0lseMFXch-pbTsW8pI3kXw8DtyEOTKB6zNIzW58lzexrEd5G8Hdvn7ElnfaIXD-cl-_bxw9ftZ3F1_Wm3fXclnKpxEo2spKuazmqLunEAJSi1UfnvqsOSnNUNkpKqaDqsddVmV2k7W7ZFUSurUF2y12dujuP7TGkyQ58c-bwDhTkZmRPe6LqEKkvlWepiSClSZw6xH2xcDII5NWPOzZjcjPnTjFmy6dUDf24Gav9Z_laRBeosSPlp3FM0t2GOOZL0P-xvchmdag</recordid><startdate>20191101</startdate><enddate>20191101</enddate><creator>O’Doherty, Brian</creator><creator>Dorman, Jane</creator><creator>McGrath, Karen</creator><creator>Kelly, Kevin</creator><creator>Molony, David</creator><creator>Lacey, Seán</creator><creator>Whelan, Sarah</creator><creator>Schmid, Simon</creator><creator>Sullivan, Shane</creator><general>Springer London</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20191101</creationdate><title>Improvement in health status with once-daily indacaterol/glycopyrronium 110/50 μg in COPD patients: real-world evidence from an observational study in Ireland</title><author>O’Doherty, Brian ; Dorman, Jane ; McGrath, Karen ; Kelly, Kevin ; Molony, David ; Lacey, Seán ; Whelan, Sarah ; Schmid, Simon ; Sullivan, Shane</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c391t-b282c8bfa6a16bc005033732653f15eca6b1e3234bf1968dc395afa5d4493a313</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adrenergic beta-2 Receptor Agonists - administration &amp; dosage</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Bronchodilator Agents - administration &amp; dosage</topic><topic>Family Medicine</topic><topic>Female</topic><topic>General Practice</topic><topic>Glycopyrrolate - administration &amp; dosage</topic><topic>Health Status</topic><topic>Humans</topic><topic>Indans - administration &amp; dosage</topic><topic>Internal Medicine</topic><topic>Ireland</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Muscarinic Antagonists - administration &amp; dosage</topic><topic>Original Article</topic><topic>Prospective Studies</topic><topic>Pulmonary Disease, Chronic Obstructive - drug therapy</topic><topic>Quinolones - administration &amp; dosage</topic><topic>Severity of Illness Index</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>O’Doherty, Brian</creatorcontrib><creatorcontrib>Dorman, Jane</creatorcontrib><creatorcontrib>McGrath, Karen</creatorcontrib><creatorcontrib>Kelly, Kevin</creatorcontrib><creatorcontrib>Molony, David</creatorcontrib><creatorcontrib>Lacey, Seán</creatorcontrib><creatorcontrib>Whelan, Sarah</creatorcontrib><creatorcontrib>Schmid, Simon</creatorcontrib><creatorcontrib>Sullivan, Shane</creatorcontrib><collection>SpringerOpen</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Irish journal of medical science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>O’Doherty, Brian</au><au>Dorman, Jane</au><au>McGrath, Karen</au><au>Kelly, Kevin</au><au>Molony, David</au><au>Lacey, Seán</au><au>Whelan, Sarah</au><au>Schmid, Simon</au><au>Sullivan, Shane</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Improvement in health status with once-daily indacaterol/glycopyrronium 110/50 μg in COPD patients: real-world evidence from an observational study in Ireland</atitle><jtitle>Irish journal of medical science</jtitle><stitle>Ir J Med Sci</stitle><addtitle>Ir J Med Sci</addtitle><date>2019-11-01</date><risdate>2019</risdate><volume>188</volume><issue>4</issue><spage>1251</spage><epage>1259</epage><pages>1251-1259</pages><issn>0021-1265</issn><eissn>1863-4362</eissn><abstract>Aims Indacaterol/glycopyrronium (IND/GLY) 110/50 μg is a once-daily (o.d.) fixed-dose combination of long-acting β 2 -agonist/long-acting muscarinic antagonist approved in over 90 countries, including Ireland, for the management of COPD. The present study was conducted to evaluate health status of COPD patients, initiated on IND/GLY 110/50 μg o.d., using the Clinical COPD Questionnaire (CCQ) tool in a real-world primary care setting in Ireland. Methods This was a real-world, prospective, open-label study. COPD patients aged &gt; 40 years and with a smoking history of &gt; 10 pack-years were included and switched to once-daily IND/GLY 110/50 μg. Enrolment of patients into the study occurred only after the decision had been made by the physician to prescribe IND/GLY 110/50 μg. Data were collected at baseline and Week 26. Health status was assessed using the validated CCQ. Results A total of 200 patients were included in study. The mean CCQ total score decreased from 2.36 at baseline to 1.44 at Week 26 (Δ, 0.92; P  &lt; 0.0005). Of the 156 patients who completed study, 113 (72.4%) achieved minimum clinically important difference in CCQ total score with IND/GLY 110/50 μg. CCQ domain scores also decreased during the study. Improvement in health status was observed across all GOLD groups and irrespective of prior COPD treatment. Adverse events were reported by 20% of patients with COPD exacerbation/infected COPD being the most common AE, reported by 11 patients. Conclusions In real-life clinical practice in Ireland, IND/GLY 110/50 μg o.d. demonstrated statistically significant and clinically important improvement in health status in patients with COPD.</abstract><cop>London</cop><pub>Springer London</pub><pmid>30924006</pmid><doi>10.1007/s11845-019-02001-y</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects Adrenergic beta-2 Receptor Agonists - administration & dosage
Adult
Aged
Aged, 80 and over
Bronchodilator Agents - administration & dosage
Family Medicine
Female
General Practice
Glycopyrrolate - administration & dosage
Health Status
Humans
Indans - administration & dosage
Internal Medicine
Ireland
Male
Medicine
Medicine & Public Health
Middle Aged
Muscarinic Antagonists - administration & dosage
Original Article
Prospective Studies
Pulmonary Disease, Chronic Obstructive - drug therapy
Quinolones - administration & dosage
Severity of Illness Index
Surveys and Questionnaires
Treatment Outcome
title Improvement in health status with once-daily indacaterol/glycopyrronium 110/50 μg in COPD patients: real-world evidence from an observational study in Ireland
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