Effect of Age on Efficacy and Safety of Fluticasone Furoate/Vilanterol , and UMEC + FF/VI in Patients with Chronic Obstructive Pulmonary Disease: Analyses of Five Randomized Clinical Trials
Introduction: Concerns have been raised about the practical use and clinical benefits of medications and inhalers in older patients with chronic obstructive pulmonary disease (COPD). Here, we report analyses according to age from five clinical trials evaluating medications administered using the ELL...
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| Veröffentlicht in: | International journal of chronic obstructive pulmonary disease 2021-07, Vol.16, p.1925 |
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| container_title | International journal of chronic obstructive pulmonary disease |
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| creator | Hanania, Nicola A Caveney, Scott Soule, Tedi Tombs, Lee Lettis, Sally Crim, Courtney Mannino, David M Patel, Hitesh Boucot, Isabelle H |
| description | Introduction: Concerns have been raised about the practical use and clinical benefits of medications and inhalers in older patients with chronic obstructive pulmonary disease (COPD). Here, we report analyses according to age from five clinical trials evaluating medications administered using the ELLIPTA dry-powder inhaler (DPI). Methods: Efficacy and safety according to age groups ( |
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| fullrecord | <record><control><sourceid>gale</sourceid><recordid>TN_cdi_gale_infotracmisc_A672647714</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A672647714</galeid><sourcerecordid>A672647714</sourcerecordid><originalsourceid>FETCH-LOGICAL-g674-ee187dd2ea939448c39a14ba15740a344beabed7ac17fda62e1aed52d18398733</originalsourceid><addsrcrecordid>eNptkMFOAjEQhvegiYi-wyQeFaG7Zbt4IyurJBiIIlcytLNQU9pkWzT4br6bBT14MHP4J_98808yJ0mLMVF00l6vf5ace_8Wm1wI1kq-RnVNMoCrYbgmcBaioSXKPaBV8II1hf1hWpldiL53lqDaNQ4DdRfaoA3UOAM3R_z1aVTCNVRVdzEGbWGGQZMNHj502EC5aZzVEqYrH5qdDPqdYLYzW2ex2cO99oSe7mBo0ew9-ePVA_Mco91Wf5KC0uiYgAbmjUbjL5LTOgpd_mo7mVejefnYmUwfxuVw0lnngneIWCGUSgkH2YDzQmYDZHyFrC94DzPOV4QrUgIlE7XCPCWGpPqpYkU2KESWtZOrn9g1GlpqW7vQoNxqL5fDXKQ5j6_kkbr9h4qlaKtl_Futo_9n4RvndH9V</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Effect of Age on Efficacy and Safety of Fluticasone Furoate/Vilanterol , and UMEC + FF/VI in Patients with Chronic Obstructive Pulmonary Disease: Analyses of Five Randomized Clinical Trials</title><source>DOAJ Directory of Open Access Journals</source><source>Dove Press Free</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central Open Access</source><source>Access via Taylor & Francis (Open Access Collection)</source><source>PubMed Central</source><creator>Hanania, Nicola A ; Caveney, Scott ; Soule, Tedi ; Tombs, Lee ; Lettis, Sally ; Crim, Courtney ; Mannino, David M ; Patel, Hitesh ; Boucot, Isabelle H</creator><creatorcontrib>Hanania, Nicola A ; Caveney, Scott ; Soule, Tedi ; Tombs, Lee ; Lettis, Sally ; Crim, Courtney ; Mannino, David M ; Patel, Hitesh ; Boucot, Isabelle H</creatorcontrib><description>Introduction: Concerns have been raised about the practical use and clinical benefits of medications and inhalers in older patients with chronic obstructive pulmonary disease (COPD). Here, we report analyses according to age from five clinical trials evaluating medications administered using the ELLIPTA dry-powder inhaler (DPI). Methods: Efficacy and safety according to age groups (<65 and [greater than or equal to] 65 years) were assessed using data from five clinical trials in patients [greater than or equal to] 40 years of age with symptomatic COPD. There was a mix of pre-specified and post hoc analyses of two 24-week trials with fluticasone furoate (FF)/vilanterol (VI) 100/25 [micro]g; one 24-week trial with umeclidinium (UMEC) 62.5 [micro]g; and two 12-week trials with UMEC 62.5 [micro]g + FF/VI 100/25 [micro]g. The primary endpoint was trough forced expiratory volume in 1 second ([FEV.sub.1]) obtained 23 and 24 hours after dosing on the last day of the study. Results: A total of 2876 patients <65 years of age and 2148 patients [greater than or equal to] 65 years of age were enrolled across all studies of whom 1333 and 1111 patients, respectively, received treatment at the doses presented. Statistically significant and clinically meaningful treatment differences in improvement from baseline in mean trough [FEV.sub.1] were reported for active comparators versus placebo at study end for both <65 and [greater than or equal to] 65 years subgroups (FF/VI vs placebo: 143 mL and 111 mL; UMEC vs placebo: 110 mL and 123 mL; UMEC + FF/VI vs placebo + FF/VI: 136 mL and 105 mL; p<0.001 for all comparisons). The incidence of adverse events reported for active treatments was similar between age groups. Conclusion: These data provide evidence to support the use of FF/VI, UMEC, or UMEC + FF/VI, all delivered via the ELLIPTA DPI, to treat older ([greater than or equal to] 65 years) and younger (<65 years) patients with COPD. Keywords: COPD, elderly, ELLIPTA dry-powder inhaler, fluticasone furoate/vilanterol, multiple-inhaler triple therapy, umeclidinium</description><identifier>ISSN: 1178-2005</identifier><language>eng</language><publisher>Dove Medical Press Limited</publisher><subject>Clinical trials ; Lung diseases, Obstructive ; Medical research ; Medicine, Experimental ; Respiratory agents</subject><ispartof>International journal of chronic obstructive pulmonary disease, 2021-07, Vol.16, p.1925</ispartof><rights>COPYRIGHT 2021 Dove Medical Press Limited</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786</link.rule.ids></links><search><creatorcontrib>Hanania, Nicola A</creatorcontrib><creatorcontrib>Caveney, Scott</creatorcontrib><creatorcontrib>Soule, Tedi</creatorcontrib><creatorcontrib>Tombs, Lee</creatorcontrib><creatorcontrib>Lettis, Sally</creatorcontrib><creatorcontrib>Crim, Courtney</creatorcontrib><creatorcontrib>Mannino, David M</creatorcontrib><creatorcontrib>Patel, Hitesh</creatorcontrib><creatorcontrib>Boucot, Isabelle H</creatorcontrib><title>Effect of Age on Efficacy and Safety of Fluticasone Furoate/Vilanterol , and UMEC + FF/VI in Patients with Chronic Obstructive Pulmonary Disease: Analyses of Five Randomized Clinical Trials</title><title>International journal of chronic obstructive pulmonary disease</title><description>Introduction: Concerns have been raised about the practical use and clinical benefits of medications and inhalers in older patients with chronic obstructive pulmonary disease (COPD). Here, we report analyses according to age from five clinical trials evaluating medications administered using the ELLIPTA dry-powder inhaler (DPI). Methods: Efficacy and safety according to age groups (<65 and [greater than or equal to] 65 years) were assessed using data from five clinical trials in patients [greater than or equal to] 40 years of age with symptomatic COPD. There was a mix of pre-specified and post hoc analyses of two 24-week trials with fluticasone furoate (FF)/vilanterol (VI) 100/25 [micro]g; one 24-week trial with umeclidinium (UMEC) 62.5 [micro]g; and two 12-week trials with UMEC 62.5 [micro]g + FF/VI 100/25 [micro]g. The primary endpoint was trough forced expiratory volume in 1 second ([FEV.sub.1]) obtained 23 and 24 hours after dosing on the last day of the study. Results: A total of 2876 patients <65 years of age and 2148 patients [greater than or equal to] 65 years of age were enrolled across all studies of whom 1333 and 1111 patients, respectively, received treatment at the doses presented. Statistically significant and clinically meaningful treatment differences in improvement from baseline in mean trough [FEV.sub.1] were reported for active comparators versus placebo at study end for both <65 and [greater than or equal to] 65 years subgroups (FF/VI vs placebo: 143 mL and 111 mL; UMEC vs placebo: 110 mL and 123 mL; UMEC + FF/VI vs placebo + FF/VI: 136 mL and 105 mL; p<0.001 for all comparisons). The incidence of adverse events reported for active treatments was similar between age groups. Conclusion: These data provide evidence to support the use of FF/VI, UMEC, or UMEC + FF/VI, all delivered via the ELLIPTA DPI, to treat older ([greater than or equal to] 65 years) and younger (<65 years) patients with COPD. Keywords: COPD, elderly, ELLIPTA dry-powder inhaler, fluticasone furoate/vilanterol, multiple-inhaler triple therapy, umeclidinium</description><subject>Clinical trials</subject><subject>Lung diseases, Obstructive</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Respiratory agents</subject><issn>1178-2005</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid/><recordid>eNptkMFOAjEQhvegiYi-wyQeFaG7Zbt4IyurJBiIIlcytLNQU9pkWzT4br6bBT14MHP4J_98808yJ0mLMVF00l6vf5ace_8Wm1wI1kq-RnVNMoCrYbgmcBaioSXKPaBV8II1hf1hWpldiL53lqDaNQ4DdRfaoA3UOAM3R_z1aVTCNVRVdzEGbWGGQZMNHj502EC5aZzVEqYrH5qdDPqdYLYzW2ex2cO99oSe7mBo0ew9-ePVA_Mco91Wf5KC0uiYgAbmjUbjL5LTOgpd_mo7mVejefnYmUwfxuVw0lnngneIWCGUSgkH2YDzQmYDZHyFrC94DzPOV4QrUgIlE7XCPCWGpPqpYkU2KESWtZOrn9g1GlpqW7vQoNxqL5fDXKQ5j6_kkbr9h4qlaKtl_Futo_9n4RvndH9V</recordid><startdate>20210731</startdate><enddate>20210731</enddate><creator>Hanania, Nicola A</creator><creator>Caveney, Scott</creator><creator>Soule, Tedi</creator><creator>Tombs, Lee</creator><creator>Lettis, Sally</creator><creator>Crim, Courtney</creator><creator>Mannino, David M</creator><creator>Patel, Hitesh</creator><creator>Boucot, Isabelle H</creator><general>Dove Medical Press Limited</general><scope/></search><sort><creationdate>20210731</creationdate><title>Effect of Age on Efficacy and Safety of Fluticasone Furoate/Vilanterol , and UMEC + FF/VI in Patients with Chronic Obstructive Pulmonary Disease: Analyses of Five Randomized Clinical Trials</title><author>Hanania, Nicola A ; Caveney, Scott ; Soule, Tedi ; Tombs, Lee ; Lettis, Sally ; Crim, Courtney ; Mannino, David M ; Patel, Hitesh ; Boucot, Isabelle H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g674-ee187dd2ea939448c39a14ba15740a344beabed7ac17fda62e1aed52d18398733</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Clinical trials</topic><topic>Lung diseases, Obstructive</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Respiratory agents</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hanania, Nicola A</creatorcontrib><creatorcontrib>Caveney, Scott</creatorcontrib><creatorcontrib>Soule, Tedi</creatorcontrib><creatorcontrib>Tombs, Lee</creatorcontrib><creatorcontrib>Lettis, Sally</creatorcontrib><creatorcontrib>Crim, Courtney</creatorcontrib><creatorcontrib>Mannino, David M</creatorcontrib><creatorcontrib>Patel, Hitesh</creatorcontrib><creatorcontrib>Boucot, Isabelle H</creatorcontrib><jtitle>International journal of chronic obstructive pulmonary disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hanania, Nicola A</au><au>Caveney, Scott</au><au>Soule, Tedi</au><au>Tombs, Lee</au><au>Lettis, Sally</au><au>Crim, Courtney</au><au>Mannino, David M</au><au>Patel, Hitesh</au><au>Boucot, Isabelle H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Age on Efficacy and Safety of Fluticasone Furoate/Vilanterol , and UMEC + FF/VI in Patients with Chronic Obstructive Pulmonary Disease: Analyses of Five Randomized Clinical Trials</atitle><jtitle>International journal of chronic obstructive pulmonary disease</jtitle><date>2021-07-31</date><risdate>2021</risdate><volume>16</volume><spage>1925</spage><pages>1925-</pages><issn>1178-2005</issn><abstract>Introduction: Concerns have been raised about the practical use and clinical benefits of medications and inhalers in older patients with chronic obstructive pulmonary disease (COPD). Here, we report analyses according to age from five clinical trials evaluating medications administered using the ELLIPTA dry-powder inhaler (DPI). Methods: Efficacy and safety according to age groups (<65 and [greater than or equal to] 65 years) were assessed using data from five clinical trials in patients [greater than or equal to] 40 years of age with symptomatic COPD. There was a mix of pre-specified and post hoc analyses of two 24-week trials with fluticasone furoate (FF)/vilanterol (VI) 100/25 [micro]g; one 24-week trial with umeclidinium (UMEC) 62.5 [micro]g; and two 12-week trials with UMEC 62.5 [micro]g + FF/VI 100/25 [micro]g. The primary endpoint was trough forced expiratory volume in 1 second ([FEV.sub.1]) obtained 23 and 24 hours after dosing on the last day of the study. Results: A total of 2876 patients <65 years of age and 2148 patients [greater than or equal to] 65 years of age were enrolled across all studies of whom 1333 and 1111 patients, respectively, received treatment at the doses presented. Statistically significant and clinically meaningful treatment differences in improvement from baseline in mean trough [FEV.sub.1] were reported for active comparators versus placebo at study end for both <65 and [greater than or equal to] 65 years subgroups (FF/VI vs placebo: 143 mL and 111 mL; UMEC vs placebo: 110 mL and 123 mL; UMEC + FF/VI vs placebo + FF/VI: 136 mL and 105 mL; p<0.001 for all comparisons). The incidence of adverse events reported for active treatments was similar between age groups. Conclusion: These data provide evidence to support the use of FF/VI, UMEC, or UMEC + FF/VI, all delivered via the ELLIPTA DPI, to treat older ([greater than or equal to] 65 years) and younger (<65 years) patients with COPD. Keywords: COPD, elderly, ELLIPTA dry-powder inhaler, fluticasone furoate/vilanterol, multiple-inhaler triple therapy, umeclidinium</abstract><pub>Dove Medical Press Limited</pub></addata></record> |
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| subjects | Clinical trials Lung diseases, Obstructive Medical research Medicine, Experimental Respiratory agents |
| title | Effect of Age on Efficacy and Safety of Fluticasone Furoate/Vilanterol , and UMEC + FF/VI in Patients with Chronic Obstructive Pulmonary Disease: Analyses of Five Randomized Clinical Trials |
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