Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study
The Asthma Salford Lung Study demonstrated the effectiveness and safety of initiating once-daily inhaled fluticasone furoate/vilanterol (FF/VI) versus continuing usual care (UC) in asthma patients in UK primary care [1]. Here, we report a detailed analysis of patient-reported outcome (PRO) endpoints...
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| Veröffentlicht in: | Respiratory medicine 2018-08, Vol.141, p.198-206 |
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| creator | Svedsater, Henrik Jones, Rupert Bosanquet, Nick Jacques, Loretta Lay-Flurrie, James Leather, David A. Vestbo, Jørgen Collier, Susan Woodcock, Ashley |
| description | The Asthma Salford Lung Study demonstrated the effectiveness and safety of initiating once-daily inhaled fluticasone furoate/vilanterol (FF/VI) versus continuing usual care (UC) in asthma patients in UK primary care [1]. Here, we report a detailed analysis of patient-reported outcome (PRO) endpoints.
Adults with symptomatic asthma maintained on inhaled corticosteroids (ICS) ± long-acting beta2-agonists (LABA) were randomized 1:1 to initiate FF/VI (100 [200]/25 μg) or continue UC. PROs were measured using the Asthma Control Test (ACT), Standardized Asthma Quality of Life Questionnaire (AQLQ [S]), Work Productivity and Activity Impairment: asthma questionnaire, and EQ-5D-3L (EuroQol 5-Dimensions 3-Levels) questionnaire, at timepoints across the 12-month study period.
The individual components of ACT response (total score ≥20 or improvement from baseline ≥3) both contributed to the composite primary effectiveness endpoint at Week 24, with odds ratios favoring FF/VI over UC in both cases. Patients initiating FF/VI versus continuing UC were more likely to maintain/improve asthma control, regardless of baseline control status. The odds of patients being responders on AQLQ (S) total score and on individual AQLQ domains at Week 52 were significantly higher for FF/VI versus UC (all p |
| doi_str_mv | 10.1016/j.rmed.2018.06.003 |
| format | Article |
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Adults with symptomatic asthma maintained on inhaled corticosteroids (ICS) ± long-acting beta2-agonists (LABA) were randomized 1:1 to initiate FF/VI (100 [200]/25 μg) or continue UC. PROs were measured using the Asthma Control Test (ACT), Standardized Asthma Quality of Life Questionnaire (AQLQ [S]), Work Productivity and Activity Impairment: asthma questionnaire, and EQ-5D-3L (EuroQol 5-Dimensions 3-Levels) questionnaire, at timepoints across the 12-month study period.
The individual components of ACT response (total score ≥20 or improvement from baseline ≥3) both contributed to the composite primary effectiveness endpoint at Week 24, with odds ratios favoring FF/VI over UC in both cases. Patients initiating FF/VI versus continuing UC were more likely to maintain/improve asthma control, regardless of baseline control status. The odds of patients being responders on AQLQ (S) total score and on individual AQLQ domains at Week 52 were significantly higher for FF/VI versus UC (all p < .001). FF/VI was associated with significantly greater reductions in overall work and activity impairment due to asthma (both p < .001), and a significantly greater change from baseline in EQ visual analogue scale score (p = .007), versus UC at Week 52. PRO findings were consistent across baseline ICS and ICS/LABA subsets.
Initiation of FF/VI versus continuing UC was associated with consistent improvements in PROs.
[Display omitted]
•Initiating FF/VI consistently improved asthma PROs vs continuing UC.•Consistent benefit of FF/VI vs UC on asthma control regardless of initial control.•Benefit at Wk 52 for FF/VI vs UC on total AQLQ and individual AQLQ domain scores.•Greater reduction in overall work and activity impairment at Wk 52 for FF/VI vs UC.•Consistent benefits of FF/VI demonstrated across all patient subsets analyzed.</description><identifier>ISSN: 0954-6111</identifier><identifier>EISSN: 1532-3064</identifier><identifier>DOI: 10.1016/j.rmed.2018.06.003</identifier><identifier>PMID: 30053967</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adrenal Cortex Hormones - therapeutic use ; Adrenergic beta-2 Receptor Agonists - therapeutic use ; Adult ; Adults ; Airway management ; Androstadienes - therapeutic use ; Asthma ; Asthma - drug therapy ; Benzyl Alcohols - therapeutic use ; Chlorobenzenes - therapeutic use ; Clinical medicine ; Clinical trials ; Corticoids ; Corticosteroids ; Drug Combinations ; Female ; Fluticasone ; Fluticasone furoate/vilanterol ; Glucocorticoids ; Health care ; Health-related quality of life ; Humans ; Impairment ; Lungs ; Male ; Patient Reported Outcome Measures ; Patient-reported outcomes ; Patients ; Prospective Studies ; Quality of life ; Questionnaires ; Real-world ; Statistical analysis ; Surveys and Questionnaires ; Treatment Outcome ; United Kingdom ; Work and activity impairment</subject><ispartof>Respiratory medicine, 2018-08, Vol.141, p.198-206</ispartof><rights>2018 The Authors</rights><rights>Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><rights>Copyright Elsevier Limited Aug 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-f112e8f77a76fb0b9254151b1025b466d1dbf3e5f2e5db7f41ca6c0321cbfb523</citedby><cites>FETCH-LOGICAL-c428t-f112e8f77a76fb0b9254151b1025b466d1dbf3e5f2e5db7f41ca6c0321cbfb523</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.rmed.2018.06.003$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30053967$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Svedsater, Henrik</creatorcontrib><creatorcontrib>Jones, Rupert</creatorcontrib><creatorcontrib>Bosanquet, Nick</creatorcontrib><creatorcontrib>Jacques, Loretta</creatorcontrib><creatorcontrib>Lay-Flurrie, James</creatorcontrib><creatorcontrib>Leather, David A.</creatorcontrib><creatorcontrib>Vestbo, Jørgen</creatorcontrib><creatorcontrib>Collier, Susan</creatorcontrib><creatorcontrib>Woodcock, Ashley</creatorcontrib><title>Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study</title><title>Respiratory medicine</title><addtitle>Respir Med</addtitle><description>The Asthma Salford Lung Study demonstrated the effectiveness and safety of initiating once-daily inhaled fluticasone furoate/vilanterol (FF/VI) versus continuing usual care (UC) in asthma patients in UK primary care [1]. Here, we report a detailed analysis of patient-reported outcome (PRO) endpoints.
Adults with symptomatic asthma maintained on inhaled corticosteroids (ICS) ± long-acting beta2-agonists (LABA) were randomized 1:1 to initiate FF/VI (100 [200]/25 μg) or continue UC. PROs were measured using the Asthma Control Test (ACT), Standardized Asthma Quality of Life Questionnaire (AQLQ [S]), Work Productivity and Activity Impairment: asthma questionnaire, and EQ-5D-3L (EuroQol 5-Dimensions 3-Levels) questionnaire, at timepoints across the 12-month study period.
The individual components of ACT response (total score ≥20 or improvement from baseline ≥3) both contributed to the composite primary effectiveness endpoint at Week 24, with odds ratios favoring FF/VI over UC in both cases. Patients initiating FF/VI versus continuing UC were more likely to maintain/improve asthma control, regardless of baseline control status. The odds of patients being responders on AQLQ (S) total score and on individual AQLQ domains at Week 52 were significantly higher for FF/VI versus UC (all p < .001). FF/VI was associated with significantly greater reductions in overall work and activity impairment due to asthma (both p < .001), and a significantly greater change from baseline in EQ visual analogue scale score (p = .007), versus UC at Week 52. PRO findings were consistent across baseline ICS and ICS/LABA subsets.
Initiation of FF/VI versus continuing UC was associated with consistent improvements in PROs.
[Display omitted]
•Initiating FF/VI consistently improved asthma PROs vs continuing UC.•Consistent benefit of FF/VI vs UC on asthma control regardless of initial control.•Benefit at Wk 52 for FF/VI vs UC on total AQLQ and individual AQLQ domain scores.•Greater reduction in overall work and activity impairment at Wk 52 for FF/VI vs UC.•Consistent benefits of FF/VI demonstrated across all patient subsets analyzed.</description><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Adrenergic beta-2 Receptor Agonists - therapeutic use</subject><subject>Adult</subject><subject>Adults</subject><subject>Airway management</subject><subject>Androstadienes - therapeutic use</subject><subject>Asthma</subject><subject>Asthma - drug therapy</subject><subject>Benzyl Alcohols - therapeutic use</subject><subject>Chlorobenzenes - therapeutic use</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Corticoids</subject><subject>Corticosteroids</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Fluticasone</subject><subject>Fluticasone furoate/vilanterol</subject><subject>Glucocorticoids</subject><subject>Health care</subject><subject>Health-related quality of life</subject><subject>Humans</subject><subject>Impairment</subject><subject>Lungs</subject><subject>Male</subject><subject>Patient Reported Outcome Measures</subject><subject>Patient-reported outcomes</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Real-world</subject><subject>Statistical analysis</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><subject>United Kingdom</subject><subject>Work and activity impairment</subject><issn>0954-6111</issn><issn>1532-3064</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kctu1DAUQC0EotPCD7BAltiwSXrtOM5EYlNVQJFGAqmwthznmvEoiQc_BvUT-GscTbthwcoLn3tk30PIGwY1AyavD3WYcaw5sG0NsgZonpENaxteNSDFc7KBvhWVZIxdkMsYDwDQCwEvyUUD0Da97DbkzzedHC6pCnj0IeFIfU7Gzxjpb5f21C0uuYL4hXpL7ZSTMzr6BanNweuE1yc36SVh8BM9YYg5UuOX5Jbslp80x6wnanTAYqJpj_Qmpv2s6b2erA8j3eVC3ac8PrwiL6yeIr5-PK_Ij08fv9_eVbuvn7_c3uwqI_g2VZYxjlvbdbqTdoCh561gLRsY8HYQUo5sHGyDreXYjkNnBTNaGmg4M4MdWt5ckfdn7zH4XxljUrOLBqfyC_Q5Kg7dtu2LTRT03T_oweewlNetVAEE46uQnykTfIwBrToGN-vwoBioNZQ6qDWUWkMpkKqEKkNvH9V5WO-eRp7KFODDGcCyi5PDoKIpoQyOLqBJavTuf_6_X2mm_w</recordid><startdate>201808</startdate><enddate>201808</enddate><creator>Svedsater, Henrik</creator><creator>Jones, Rupert</creator><creator>Bosanquet, Nick</creator><creator>Jacques, Loretta</creator><creator>Lay-Flurrie, James</creator><creator>Leather, David A.</creator><creator>Vestbo, Jørgen</creator><creator>Collier, Susan</creator><creator>Woodcock, Ashley</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</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>7U9</scope><scope>ASE</scope><scope>FPQ</scope><scope>H94</scope><scope>K6X</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>201808</creationdate><title>Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study</title><author>Svedsater, Henrik ; 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Here, we report a detailed analysis of patient-reported outcome (PRO) endpoints.
Adults with symptomatic asthma maintained on inhaled corticosteroids (ICS) ± long-acting beta2-agonists (LABA) were randomized 1:1 to initiate FF/VI (100 [200]/25 μg) or continue UC. PROs were measured using the Asthma Control Test (ACT), Standardized Asthma Quality of Life Questionnaire (AQLQ [S]), Work Productivity and Activity Impairment: asthma questionnaire, and EQ-5D-3L (EuroQol 5-Dimensions 3-Levels) questionnaire, at timepoints across the 12-month study period.
The individual components of ACT response (total score ≥20 or improvement from baseline ≥3) both contributed to the composite primary effectiveness endpoint at Week 24, with odds ratios favoring FF/VI over UC in both cases. Patients initiating FF/VI versus continuing UC were more likely to maintain/improve asthma control, regardless of baseline control status. The odds of patients being responders on AQLQ (S) total score and on individual AQLQ domains at Week 52 were significantly higher for FF/VI versus UC (all p < .001). FF/VI was associated with significantly greater reductions in overall work and activity impairment due to asthma (both p < .001), and a significantly greater change from baseline in EQ visual analogue scale score (p = .007), versus UC at Week 52. PRO findings were consistent across baseline ICS and ICS/LABA subsets.
Initiation of FF/VI versus continuing UC was associated with consistent improvements in PROs.
[Display omitted]
•Initiating FF/VI consistently improved asthma PROs vs continuing UC.•Consistent benefit of FF/VI vs UC on asthma control regardless of initial control.•Benefit at Wk 52 for FF/VI vs UC on total AQLQ and individual AQLQ domain scores.•Greater reduction in overall work and activity impairment at Wk 52 for FF/VI vs UC.•Consistent benefits of FF/VI demonstrated across all patient subsets analyzed.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30053967</pmid><doi>10.1016/j.rmed.2018.06.003</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present); EZB-FREE-00999 freely available EZB journals |
| subjects | Adrenal Cortex Hormones - therapeutic use Adrenergic beta-2 Receptor Agonists - therapeutic use Adult Adults Airway management Androstadienes - therapeutic use Asthma Asthma - drug therapy Benzyl Alcohols - therapeutic use Chlorobenzenes - therapeutic use Clinical medicine Clinical trials Corticoids Corticosteroids Drug Combinations Female Fluticasone Fluticasone furoate/vilanterol Glucocorticoids Health care Health-related quality of life Humans Impairment Lungs Male Patient Reported Outcome Measures Patient-reported outcomes Patients Prospective Studies Quality of life Questionnaires Real-world Statistical analysis Surveys and Questionnaires Treatment Outcome United Kingdom Work and activity impairment |
| title | Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study |
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