FF/UMEC/VI associated with clinical remission and improved outcomes in uncontrolled asthma: Results from a real-world US study

4 Nov 2026

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Clinical remission (CR), typically defined as no oral corticosteroid (OCS) use or exacerbations, controlled symptoms, and optimized or stabilized lung function sustained for ≥12 months, is a concept recognized as relevant to all asthma patients by the Global Initiative for Asthma (GINA).1 In the phase 3a CAPTAIN trial and subsequent real-world studies, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) improved lung function, reduced exacerbations, and enabled patients with uncontrolled asthma to achieve CR.1 However, understanding outcomes when FF/UMEC/VI is initiated as initial maintenance therapy (IMT) vs. step-up therapy from prior inhaled corticosteroids (ICS) is critical to inform treatment strategies.1 To address this, Stephen Noorduyn presented findings at the ERS Congress 2026 from a retrospective physician chart review in the United States evaluating the achievability of CR and clinical outcomes across these two approaches.1

Adults aged ≥18 years with uncontrolled asthma who initiated FF/UMEC/VI 100/62.5/25μg or 200/62.5/25μg between September 2020 and August 2023 and remained on treatment for ≥12 months were included in the analysis.1 Patients had ≥12 months of pre-initiation medical records and lung function data, including ≥1 forced expiratory volume in 1 second (FEV₁) measurement within 3 months before or on the index date and ≥1 FEV₁ measurement and Asthma Control Test (ACT) or 6-item Asthma Control Questionnaire (ACQ-6) score within 3 months of month 12 of the post-initiation period.1 Patients with prior FF/UMEC/VI use, previous single- or multiple-inhaler triple therapy, chronic obstructive pulmonary disease, concurrent respiratory disorders, or biologic use for asthma were not included.1

Patients included either initiated FF/UMEC/VI as IMT, with no prior ICS-containing therapy, or as step-up therapy from prior ICS-containing therapy.1 Baseline characteristics were broadly similar between the two groups.1 CR was assessed at 12 months as a composite endpoint of no OCS use and no moderate-to-severe exacerbations (systemic corticosteroids, emergency/urgent care visit, or inpatient stay for asthma), controlled symptoms (ACT ≥20 or ACQ-6 <1.5), and either optimized or stabilized lung function (≥100mL improvement in FEV₁, FEV₁ ≥80% predicted, or no worsening in FEV₁ or FEV₁% predicted from baseline).1

Overall, 33.9% and 35.5% of patients initiating FF/UMEC/VI achieved CR using the optimized lung function criterion and using the stabilized lung function criterion following treatment initiation, respectively.1 Notably, the CR rates were 41.3% and 42.2% using the optimized and stabilized lung function criteria, respectively, among patients initiating FF/UMEC/VI as IMT.1 In those who stepped up from prior ICS-containing therapy, the CR rates were 29.9% and 31.8%, respectively.1 Individual CR components also generally improved more with IMT.1

Beyond CR, initiation of FF/UMEC/VI was associated with a favorable shift in key clinical outcomes, with overall exacerbation rates reduced by 56% (rate ratio [RR]= 0.44; 95% CI: 0.38-0.51; p<0.001) and the odds of experiencing an exacerbation reduced by 76% (odds ratio [OR]=0.24; 95% CI: 0.18-0.31; p<0.001).1 The odds of achieving normal lung function were 3.68-fold higher post-initiation (OR=3.68; 95% CI: 2.79-4.86; p<0.001), while maintenance OCS use remained unchanged (p=0.368).1

This real-world study observed that a greater proportion of patients achieved CR when FF/UMEC/VI was initiated as IMT than as step-up therapy from prior ICS-containing treatment.1 The associated reductions in exacerbation rates and improvements in lung function further support timely initiation of FF/UMEC/VI in appropriate patients with uncontrolled asthma.1

References

  1. Noorduyn SG, et al. Achievability of clinical remission in patients with asthma stepping up to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or initiating FF/UMEC/VI as initial maintenance therapy: Results of a real-world US study. Presented at the European Respiratory Society (ERS) Congress 2026; September 5-9, 2026.

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