Henrik Svedsater1, Rupert Jones2, Nick Bosanquet3, Loretta Jacques4, James Lay-Flurrie5, David A Leather6, Jørgen Vestbo7, Susan Collier8, Ashley Woodcock9. 1. Value Evidence & Outcomes, GSK, Brentford, UK. Electronic address: Henrik.x.svedsater@gsk.com. 2. Clinical Trials & Health Research, Peninsula School of Medicine and Dentistry, Plymouth University, Plymouth, UK. Electronic address: rupert.jones@plymouth.ac.uk. 3. Imperial College London, London, UK. Electronic address: n.bosanquet@imperial.ac.uk. 4. Respiratory Research and Development, GSK, Uxbridge, UK. Electronic address: loretta.a.jacques@gsk.com. 5. Clinical Statistics, GSK, Uxbridge, UK. Electronic address: james.x.lay-flurrie@gsk.com. 6. Global Respiratory Franchise, GSK, Brentford, UK. Electronic address: david.a.leather@gsk.com. 7. Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK. Electronic address: Jorgen.Vestbo@manchester.ac.uk. 8. Respiratory Research and Development, GSK, Uxbridge, UK. Electronic address: sue.d.collier@gsk.com. 9. Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK. Electronic address: ashley.woodcock@manchester.ac.uk.
Abstract
BACKGROUND: 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. METHODS: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. RESULTS: 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. CONCLUSIONS: Initiation of FF/VI versus continuing UC was associated with consistent improvements in PROs.
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Initiation of FF/VI versus continuing UC was associated with consistent improvements in PROs.