Related Experiment Video
Updated: May 14, 2026
Bronchial Thermoplasty: A Novel Therapeutic Approach to Severe Asthma
Published on: November 4, 2010
Effectiveness of FF/UMEC/VI versus ICS/LABA in Patients with Uncontrolled Asthma Treated in Routine Clinical Practice
Erika Penz1,2, Stephen G Noorduyn3,4, Alison C Moore5
1Department of Medicine, Division of Respirology and Sleep Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
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.
Related Concept Videos
01:13Asthma III: Clinical Manifestations
01:30Asthma-IV: Nursing Management
First, in...
01:20Asthma: Pathogenesis and Management
Asthma is classified as allergic and non-allergic. Allergens such as dust mites, pollen, and pet dander trigger allergic asthma, while factors like cold air, intense emotions, or exercise can induce non-allergic asthma.
01:30Asthma-IV: Diagnostic and Management
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
01:26COPD: Management Using Bronchodilators and Corticosteroids
01:26Asthma-II: Pathophysiology and Classification
Additionally, environmental and genetic factors play crucial roles in determining an individual's susceptibility to asthma and the severity of their condition.
Critical processes in asthma pathophysiology include: