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Fluticasone furoate/vilanterol 200/25 mcg in Asian asthma patients: A randomized trial

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单位: [1]China Japan Friendship Hosp, Dept Resp Dis, Beijing 100029, Peoples R China [2]China Med Univ, Affiliated Hosp 1, Dept Resp Dis, Shenyang 110001, Peoples R China [3]Catholic Univ Korea, St Pauls Hosp, Dept Internal Med, Div Pulm Crit Care & Sleep Med, Seoul 130709, South Korea [4]Xinqiao Hosp, Inst Resp Dis, Chongqing 400037, Peoples R China [5]Third Mil Med Univ, Affiliated Hosp 1, Dept Resp Med, Chongqing 400038, Peoples R China [6]GSK, Quantitat Sci Div, Uxbridge UB11 1BT, Middx, England [7]GSK, Uxbridge UB11 1BT, Middx, England
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关键词: Inhaled corticosteroid Long-acting beta-agonist Active-control Efficacy Safety Fluticasone propionate

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Background: This study investigated the efficacy and safety of the inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combination fluticasone furoate (FF)/vilanterol (VI) in Asian asthma patients. Methods: A 12-week, double-blind, double-dummy, active-comparator, parallel-group, multicenter study. 309 Asian asthma patients (>= 12 years, uncontrolled with high-strength ICS or mid-dose ICS/LABA) were randomized (1: 1) and included in the intent-to-treat population; 155 received once-daily FF/VI 200/25 mcg and 154 received twice-daily fluticasone propionate (FP) 500 mcg. The primary endpoint was change from baseline in daily evening peak expiratory flow (PEF) averaged over 12 weeks. Secondary endpoints were mean change from baseline in % rescue-free 24-h periods, daily morning PEF, % symptom-free 24-h periods, and overall Asthma Quality of Life Questionnaire score. Safety assessments were performed. Results: For change from baseline in daily evening PEF, the adjusted mean treatment difference for FF/VI versus FP of 28.5 L/min (95% confidence interval [CI]: 20.1, 36.9) was clinically and statistically significant (p < 0.001). For change from baseline in % rescue-free 24-h periods, the adjusted mean treatment difference (1.0%; 95% CI: -7.3, 9.2) was not statistically significant (p = 0.821). Statistical significance could not be inferred for the remaining endpoints due to the statistical hierarchy employed. Incidence of on-treatment adverse events was similar with FF/VI (26%; 3% treatment-related; n = 1 serious) and FP (27%; 3% treatment-related; n = 2 serious); none were fatal. No further safety concerns were identified. Conclusions: FF/VI improved evening PEF over 12 weeks versus FP in Asian patients, with a similar safety profile. The results are generally consistent with a global study comparing the same treatments. (C) 2014 Published by Elsevier Ltd.

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出版当年[2014]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统 3 区 呼吸系统
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统 3 区 呼吸系统
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出版当年[2013]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Q2 RESPIRATORY SYSTEM
最新[2023]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Q2 RESPIRATORY SYSTEM

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2013版] 出版当年五年平均[2009-2013] 出版前一年[2012版] 出版后一年[2014版]

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第一作者单位: [1]China Japan Friendship Hosp, Dept Resp Dis, Beijing 100029, Peoples R China
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