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Introduction <p>Prospective, randomized evidence for clinical remission, an ambitious treatment goal relevant for all patients with asthma, with single-inhaler triple therapy (SITT) in routine care is lacking. Significant improvement in lung function and asthma control with SITT versus inhaled corticosteroid/long-acting β<sub>2</sub>-agonist (ICS/LABA) was demonstrated in PERFORM at week&#xa0;24.</p> Methods <p>PERFORM (GSK 219912/NCT06372496), a randomized, open-label, active-controlled, global pragmatic trial, evaluated the effectiveness and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus usual care ICS/LABA in adults (18–75&#xa0;years) with uncontrolled, infrequently exacerbating asthma. Secondary outcomes related to clinical remission (no oral corticosteroid use, no severe exacerbations, optimized lung function [change from baseline (CFB) in forced expiratory volume in 1&#xa0;second (FEV<sub>1</sub>) ≥ 100&#xa0;mL], asthma control [Asthma Control Questionnaire total score &lt; 1.50]) were assessed at week&#xa0;52, following prespecified analysis plans. Alternative clinical remission definitions using stabilized lung function (CFB FEV<sub>1</sub> ≥ 0&#xa0;mL) and those within Japanese guidelines were also assessed. Clinical remission responder analyses are presented as multiplicity-adjusted odds ratios. Safety was assessed throughout.</p> Results <p>Overall, 1236 participants (mean age 48.9&#xa0;years; 68.6% [<i>n</i> = 848/1236] female) were included (FF/UMEC/VI: <i>N</i> = 619/1236; ICS/LABA: <i>N</i> = 617/1236). Participants receiving FF/UMEC/VI had statistically significantly greater odds of achieving clinical remission (including optimized lung function) at week&#xa0;52 versus usual care ICS/LABA (adjusted odds ratio [95% confidence interval] 2.13 [1.54, 2.94], <i>P</i> &lt; 0.0001). Similar results were observed for alternative definitions. Week&#xa0;52 safety profile aligned with previous studies.</p> Conclusions <p>In a broad patient population with uncontrolled asthma, treatment with FF/UMEC/VI resulted in statistically significantly greater odds of achieving clinical remission versus usual care ICS/LABA in a setting reflecting routine practice, a secondary outcome of PERFORM. These findings were consistent irrespective of clinical remission definitions and provide evidence informing the use of FF/UMEC/VI in an underserved group of symptomatic patients with infrequent exacerbations and minimal lung function impairment.</p> Trial Registration <p>GSK 219912/NCT06372496.</p> Graphical Abstract <p></p>

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Clinical Remission with FF/UMEC/VI Versus ICS/LABA in Uncontrolled Asthma: The PERFORM Pragmatic Randomized Controlled Trial

  • 期刊论文

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  • 发表日期：

    2026年7月20日

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  • Stephen G. Noorduyn,
  • John J. Oppenheimer,
  • Alison C. Moore,
  • Hiroyuki Nagase,
  • Jodie Crawford,
  • Amila Poddar,
  • Victoria Boon,
  • Nicola Brown,
  • David Slade,
  • Gabriel Garcia,
  • Alan P. Baptist,
  • Erika Penz

摘要

Introduction

Prospective, randomized evidence for clinical remission, an ambitious treatment goal relevant for all patients with asthma, with single-inhaler triple therapy (SITT) in routine care is lacking. Significant improvement in lung function and asthma control with SITT versus inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) was demonstrated in PERFORM at week 24.

Methods

PERFORM (GSK 219912/NCT06372496), a randomized, open-label, active-controlled, global pragmatic trial, evaluated the effectiveness and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus usual care ICS/LABA in adults (18–75 years) with uncontrolled, infrequently exacerbating asthma. Secondary outcomes related to clinical remission (no oral corticosteroid use, no severe exacerbations, optimized lung function [change from baseline (CFB) in forced expiratory volume in 1 second (FEV1) ≥ 100 mL], asthma control [Asthma Control Questionnaire total score < 1.50]) were assessed at week 52, following prespecified analysis plans. Alternative clinical remission definitions using stabilized lung function (CFB FEV1 ≥ 0 mL) and those within Japanese guidelines were also assessed. Clinical remission responder analyses are presented as multiplicity-adjusted odds ratios. Safety was assessed throughout.

Results

Overall, 1236 participants (mean age 48.9 years; 68.6% [n = 848/1236] female) were included (FF/UMEC/VI: N = 619/1236; ICS/LABA: N = 617/1236). Participants receiving FF/UMEC/VI had statistically significantly greater odds of achieving clinical remission (including optimized lung function) at week 52 versus usual care ICS/LABA (adjusted odds ratio [95% confidence interval] 2.13 [1.54, 2.94], P < 0.0001). Similar results were observed for alternative definitions. Week 52 safety profile aligned with previous studies.

Conclusions

In a broad patient population with uncontrolled asthma, treatment with FF/UMEC/VI resulted in statistically significantly greater odds of achieving clinical remission versus usual care ICS/LABA in a setting reflecting routine practice, a secondary outcome of PERFORM. These findings were consistent irrespective of clinical remission definitions and provide evidence informing the use of FF/UMEC/VI in an underserved group of symptomatic patients with infrequent exacerbations and minimal lung function impairment.

Trial Registration

GSK 219912/NCT06372496.

Graphical Abstract