Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Theravance Biopharma, Royalty - LARVOL DELTA

Real-World Effectiveness of Single-Inhaler Triple Treatment Through Assorted Respiratory Outcomes When Switched From Multiple-Inhaler Triple Therapies (RESTART): A Prospective Cohort Study of Korean Patients With COPD. (PubMed, Int J Chron Obstruct Pulmon Dis) - "The Real-World Effectiveness of Single Inhaler Triple Treatment through Assorted Respiratory Outcomes when Switched from Multiple Inhaler Triple Therapies (RESTART) study aimed to evaluate the clinical benefits of switching from MITT to SITT using fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in a real-world Korean setting...The transition from MITT to SITT significantly improved COPD symptom management, pulmonary function, exacerbation rate, and treatment satisfaction in Korean cohort. Using a single inhaler to simplify therapy might increase patient compliance and improve clinical outcomes of COPD management."

Journal • Observational data • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Korean regulator releases post-marketing survey results on GSK’s Trelegy adverse reactions (Korea Biomedical Review) - "On April 9, the Ministry of Food and Drug Safety announced an order to change the license content for the inhalation drug combining umeclidinium, fluticasone, and vilanterol, to reflect the results of a post-marketing survey. The affected products are GSK’s Trelegy Ellipta and Trelegy 200 Ellipta inhalers...The scheduled date for the change order is May 19...According to the proposed changes to the license, the adverse event rate was 11.36 percent (15 patients, 15 events) in a six-year study of 132 patients with asthma. Of these, no serious adverse drug reactions and no unexpected adverse drug reactions for which causality could not be excluded were reported...A six-year postmarketing study of 606 patients with COPD reported a 38.61 percent (234 patients, 368 events) adverse event rate. Of these, 0.17 percent (1 patient, 2 events) were serious adverse reactions for which causality could not be excluded..."

Regulatory • Asthma • Chronic Obstructive Pulmonary Disease

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study (clinicaltrials.gov) - P4 | N=28 | Not yet recruiting | Sponsor: Thammasat University

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Real-life effectiveness of once-daily single-inhaler triple therapy (FF-UMEC-VI) after switching from dual therapy (ICS-LABA) in patients with symptomatic asthma: trelegy ellipta for real asthma control study. (PubMed, Front Allergy) - "A well-designed, protocol-driven randomized controlled trial (RCT) has demonstrated the efficacy of fluticasone furoate-umeclidinium-vilanterol (FF-UMEC-VI) in patients with asthma, but there is a lack of real-world data that can be used to translate the results of the RCT into clinical practice. Cough VAS also significantly decreased but did not reach a minimal clinically important difference. In patients with symptomatic asthma showing insufficient control, an improvement in the asthma symptoms was observed after switching to FF-UMEC-VI at the equivalent corticosteroid dose, accompanied by an improvement in FEV1."

Journal • Asthma • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

APIC: Air Pollution and Inhaled Corticosteroids in COPD (clinicaltrials.gov) - P4 | N=48 | Not yet recruiting | Sponsor: University of British Columbia | Initiation date: Jan 2025 ➔ Apr 2025

Trial initiation date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Network Meta-Analysis of Triple Therapy Inhalers Used in Moderate to Severe Chronic Obstructive Pulmonary Disease (ISPOR 2025) - "The single-inhaler fluticasone furoate/umeclidinium/vilanterol and multi-inhaler budesonide/formoterol plus tiotropium had lower point estimates than other available triple therapy combinations, but these differences were not statistically significant. All nine triple therapy regimens included in this review provide similar clinical benefits in reducing the rates of moderate to severe exacerbations... All nine triple therapy regimens included in this review provide similar clinical benefits in reducing the rates of moderate to severe exacerbations. In comparison to previous NMAs, the results of this NMA highlight that conclusions depend on the selection of studies (e.g., open-label vs. blinded), controlling the number of inhalers across treatment arms, and choice of statistical model (e.g., fixed vs random effects)."

Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Understanding How Formulary Pricing Models Shape Medication Accessibility and Financial Burden for Aging Populations (ISPOR 2025) - "Alzheimer's treatments like galantamine and rivastigmine were often in higher tiers, raising out-of-pocket costs. COPD medications, including Symbicort and Trelegy Ellipta, despite preferred tier placement, posed financial challenges. Rheumatoid arthritis drugs, particularly Humira in Tier 5, imposed heavy costs. Similarly, ischemic heart disease and type 2 diabetes medications like Eliquis and Steglatro often appeared in higher tiers, worsening adherence issues. Older patients in the U.S., particularly those dealing with chronic illnesses, still encounter significant financial pressure due to increasing prescription prices... Older patients in the U.S., particularly those dealing with chronic illnesses, still encounter significant financial pressure due to increasing prescription prices. Although initiatives such as the Inflation Reduction Act provide some assistance, the strain persists, leading to low compliance and adverse health results. The results highlight..."

Clinical • Pricing • Alzheimer's Disease • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Coronary Artery Disease • Diabetes • Heart Failure • Immunology • Inflammatory Arthritis • Metabolic Disorders • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Type 2 Diabetes Mellitus

Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma (clinicaltrials.gov) - P4 | N=1358 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2026 ➔ Nov 2025

Enrollment closed • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Effect of Chronic Mucus Hypersecretion on Patients With COPD Achieving and Maintaining Disease Stability With Fluticasone Furoate/Umeclidinium/Vilanterol Versus Budesonide/Formoterol: A FULFIL Post Hoc Analysis (ATS 2025) - No abstract available

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Exacerbation Reduction in Patients With Asthma Following Initiation of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in the United States (ATS 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

Impact of Fluticasone Furoate/Umeclidinium/Vilanterol Inhaled Therapy on a Clinical Remission Endpoint in Asthma for Patients with Type 2 Inflammation: CAPTAIN Post Hoc Analysis (ATS 2025) - No abstract available

Clinical • Retrospective data • Asthma • Immunology • Inflammation • Respiratory Diseases

Comparison of Individual and Composite Measures to Assess Disease Stability over Time in Patients with COPD Treated with Fluticasone Furoate/Umeclidinium/Vilanterol: A Post Hoc Analysis (ATS 2025) - No abstract available

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Assessment of Disease Stability in Patients With COPD Receiving Single-inhaler Therapy With Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI and UMEC/VI: Post Hoc Analysis of the IMPACT Trial (ATS 2025) - No abstract available

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Effectiveness of Switching from Multiple-Inhaler to Once-Daily Single-Inhaler Triple Therapy in Patients with COPD in a Real-World Setting in Japan. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Patients who switched from MITT to FF/UMEC/VI had reduced exacerbations and improved adherence. These results may help inform healthcare providers on the optimum management strategy for patients with COPD in Japan."

Clinical • Journal • Real-world evidence • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Access to single-inhaler triple medicines for chronic obstructive pulmonary disease in China: a national survey on accessibility and utilisation. (PubMed, J Pharm Policy Pract) - "The overall accessibility and consumption of BUD/GLY/FOR and FF/UMEC/VI were improved in China from 2020 to 2022. The implementation of the national drug price negotiation policy reduces the cost of drugs in China and plays an important role in improving the availability of the investigated drugs."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Brief Report on a Systematic Review of Real-World Effectiveness Studies of ICS/LAMA/LABA for Treatment of Adults with Asthma in the US. (PubMed, Pulm Ther) - "This brief communication reports a systematic review that identified few sources of SITT or MITT in US patients with asthma. Although inclusion of observational studies can result in reporting/selection bias, we identified greater clinical benefits with triple therapies versus dual therapies."

Journal • Real-world evidence • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Effects of seasonality and treatment on COPD clinical outcomes: IMPACT post hoc analysis. (PubMed, ERJ Open Res) - "Exacerbation risk was significantly reduced with FF/UMEC/VI versus dual therapy regardless of season, highlighting the durability of response with triple therapy. https://bit.ly/47KAhmK."

Clinical data • Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Clinical and Economic Evaluation of Fluticasone Furoate/Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol Therapy in Maintenance Treatment-Naive Patients with COPD in the US. (PubMed, Int J Chron Obstruct Pulmon Dis) - P=N/A | "These results support treatment recommendations for LAMA+LABA as initial maintenance therapy. ClinicalTrials.gov identifier - NCT05169424."

Clinical • HEOR • Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

The efficacy and safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) on cough symptoms in adult patients with asthma, A randomized double-blind, placebo-controlled, parallel group study: Chronic Cough in Asthma (COCOA) study. (PubMed, J Asthma) - "The change from baseline in morning and evening FEV1 increased in the FF/UMEC/VI group as with the results of peak expiratory flow. No significant adverse events associated with FF/UMEC/VI were noted.Conclusions In asthma patients with persistent cough, FF/UMEC/VI showed an early response and a significant effect on cough and lung function for 6 weeks of treatment.This study is registered with jRCTs031210412."

Clinical • Journal • Asthma • Chronic Cough • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

Retrospective Cohort Study of Elderly Users of Single- or Multiple-Inhaler Triple Therapy for the Treatment of Asthma in the USA. (PubMed, Pulm Ther) - "Triple therapy is often initiated following use of other asthma controller medications in real-world practice. Substantial rescue medication use and high disease and economic burden among this elderly patient population suggest that their asthma was not adequately controlled prior to triple therapy initiation. This retrospective study provides an early profile of elderly patients with asthma in the USA."

Journal • Retrospective data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database. (PubMed, Front Pharmacol) - "Notably, this study found an association between the above PTs and drugs, and the causal relationship needs to be verified by further longitudinal studies. Our study provides a preliminary exploration of the safety of clinical use of BUD/GLY/FOR and FF/UMEC/VI, and clinicians should be alert to potential adverse effects."

Adverse events • Journal • Asthma • Candidiasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Effect of non-spherical shape of dry powder aerosol drugs on their airway deposition distribution. (PubMed, Int J Pharm) - "Aerosol particles of Bretaris® Genuair®, Buventol® Easyhaler® and Trelegy® Ellipta® were collected on the stages of a Next Generation Impactor after their emission from the dry powder inhalers...Although there was some inter-drug difference in terms of shape factors, the values were quite close to unity (usually between 1.02 and 1.06), except for the fiber-shaped particles representing a minority in the composition of Trelegy® Ellipta®, which could be characterized by shape factors of around 1.6. The results of computer simulations of deposition distribution indicate that neglecting the irregular shape does not lead to a major distortion of the simulation results unless fiber-shaped particles are also present after the formulation."

Journal

Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma (clinicaltrials.gov) - P3 | N=356 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Comparative Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol and Budesonide/Glycopyrrolate/Formoterol Fumarate among US Patients with Chronic Obstructive Pulmonary Disease. (PubMed, Adv Ther) - "In this real-world comparative effectiveness study, FF/UMEC/VI was associated with significantly lower rate and risk of COPD exacerbations than BUD/GLY/FORM."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Medicare Advantage Population in the United States: Outcomes of Patients with Asthma Treated with ICS/LABA Before and After Initiation with Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI). (PubMed, Adv Ther) - "Initiation of FF/UMEC/VI after ICS/LABA treatment among Medicare Advantage-insured patients with asthma was associated with reduced rates of asthma-related exacerbations, ED and OP visits, and healthcare costs, highlighting the benefits of therapy escalation among this patient population."

Journal • Medicare • Reimbursement • US reimbursement • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases