Effectiveness of FF/UMEC/VI versus ICS/LABA in Patients with Uncontrolled Asthma Treated in Routine Clinical Practice (PERFORM): A Pragmatic Randomized Controlled Trial.

IF 3.3 3区医学 Q2 ALLERGY

Journal of Asthma and Allergy Pub Date : 2026-05-07 eCollection Date: 2026-01-01 DOI:10.2147/JAA.S599766

Erika Penz, Stephen G Noorduyn, Alison C Moore, Hiroyuki Nagase, Jodie Crawford, Mary Woessner, Lydia Demetriou, Nicola Brown, David Slade, Gabriel Garcia, Alan P Baptist, John J Oppenheimer

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引用次数: 0

Abstract

Purpose: Asthma guidelines recommend stepwise escalation of inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) therapy, yet many patients remain uncontrolled. Randomized controlled trials (RCTs) show that single-inhaler triple therapy improves lung function, with varying effects on symptoms and exacerbations. However, highly controlled explanatory RCTs with selective populations may not reflect real-world care. PERFORM evaluated the effectiveness and safety of initiating once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) ELLIPTA versus usual care non-ELLIPTA ICS/LABA in routine clinical practice.

Methods: PERFORM (GSK219912/NCT06372496) is a randomized, open-label, active-controlled, 52-week, global pragmatic trial including adults (18-75 years) with uncontrolled, infrequently exacerbating asthma, previously untreated or treated with non-ELLIPTA ICS or ICS/LABA in the 3-months pre-randomization. Powered primary and secondary endpoints were change from baseline in trough forced expiratory volume in 1 second (FEV₁) and asthma control (Asthma Control Questionnaire [ACQ]-7 responder analysis) at Week 24 (W24). Safety was assessed throughout the trial.

Results: Overall, 1236 patients (mean age: 48.9 years; 68.6% female) were included in this W24 primary analysis (FF/UMEC/VI: N=619; ICS/LABA: N=617). At baseline mean FEV₁%predicted was 85.7; mean ACQ-7 score was 2.46. At W24, FF/UMEC/VI statistically significantly improved trough FEV₁ from baseline versus ICS/LABA (least squares mean difference [95% confidence interval]: +68mL [36-99], P<0.001). FEV₁ improvement from baseline was 178mL (139-217) with FF/UMEC/VI and 110mL (72-149) with ICS/LABA. Odds of a clinically meaningful response in ACQ-7 score (≥0.5-point improvement from baseline) were significantly greater with FF/UMEC/VI versus ICS/LABA (odds ratio [95% confidence interval]: 1.47 [1.13-1.92], P<0.004); 79.0% of patients achieved a response with FF/UMEC/VI and 71.8% with ICS/LABA. Safety profile to W24 aligned with previous studies.

Conclusion: This pragmatic RCT demonstrated significant improvements in lung function and asthma control with FF/UMEC/VI versus ICS/LABA in uncontrolled and infrequently exacerbating patients treated in a routine practice setting. These findings further inform the evidence base for optimized use of FF/UMEC/VI.

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FF/UMEC/VI与ICS/LABA在常规临床实践中治疗的未控制哮喘患者中的有效性（PERFORM）：一项实用的随机对照试验

目的：哮喘指南建议逐步增加吸入皮质类固醇/长效β2激动剂（ICS/LABA）治疗，但许多患者仍然无法控制。随机对照试验（RCTs）显示，单吸入器三联疗法可改善肺功能，对症状和加重的影响各不相同。然而，选择性人群的高度控制解释性随机对照试验可能不能反映现实世界的护理。在常规临床实践中，PERFORM评估了每日一次的糠酸氟替卡松/乌莫利维坦/维兰特罗（FF/UMEC/VI） ELLIPTA与常规护理非ELLIPTA ICS/LABA的有效性和安全性。方法：PERFORM （GSK219912/NCT06372496）是一项随机、开放标签、主动对照、52周的全球实用试验，包括18-75岁未受控制、不经常加重的哮喘患者，在3个月的预随机化期间未接受治疗或接受非ellipta ICS或ICS/LABA治疗。第24周（W24）的主要和次要终点是1秒内呼气量（FEV1）和哮喘控制（哮喘控制问卷[ACQ]-7应答者分析）较基线的变化。在整个试验过程中对安全性进行了评估。结果：总的来说，1236例患者（平均年龄48.9岁，68.6%为女性）被纳入W24主要分析（FF/UMEC/VI: N=619; ICS/LABA: N=617）。基线时预测平均fev1 %为85.7；平均ACQ-7评分为2.46分。在W24时，FF/UMEC/VI与ICS/LABA相比，通过FEV1较基线有统计学显著改善（最小二乘平均差[95%置信区间]:+68mL [36-99]）， FF/UMEC/VI较基线改善的P1为178mL (139-217)， ICS/LABA为110mL（72-149）。与ICS/LABA相比，FF/UMEC/VI在ACQ-7评分（较基线改善≥0.5分）方面取得临床有意义反应的几率显著更高（优势比[95%置信区间]:1.47[1.13-1.92]）。结论：该实用的随机对照试验显示，在常规实践环境中治疗的未控制和罕见加重患者中，FF/UMEC/VI与ICS/LABA相比，在肺功能和哮喘控制方面有显著改善。这些发现进一步为FF/UMEC/VI的优化使用提供了证据基础。

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来源期刊

Journal of Asthma and Allergy Medicine-Immunology and Allergy

CiteScore

5.30

自引率

6.20%

发文量

185

审稿时长

16 weeks

期刊介绍： An international, peer-reviewed journal publishing original research, reports, editorials and commentaries on the following topics: Asthma; Pulmonary physiology; Asthma related clinical health; Clinical immunology and the immunological basis of disease; Pharmacological interventions and new therapies. Although the main focus of the journal will be to publish research and clinical results in humans, preclinical, animal and in vitro studies will be published where they shed light on disease processes and potential new therapies.