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

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=1366 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jan 2026 ➔ Mar 2027

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

Critical Evaluation of Fluticasone Furoate/Umeclidinium/Vilanterol in Asthma Cough Management: Insights and Limitations from the COCOA Study. (PubMed, J Asthma) - No abstract available

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

COST-UTILITY ANALYSIS OF BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL FUMARATE VERSUS FLUTICASONE FUROATE/UMECLIDINIUM/VILANTEROL FOR MODERATE-TO-VERY SEVERE COPD IN CHINA (ISPOR 2026) - "BGF represents a cost-saving and more effective therapeutic option for moderate-to-very severe COPD in China versus FF/UMEC/VI. By integrating local RWE and accounting for survival benefits, this study demonstrates that BGF's clinical advantages translate into considerable economic value, supporting its prioritization in Chinese payer policy decision-making."

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

A UNITED STATES BUDGET IMPACT ANALYSIS OF BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL FUMARATE IN THE TREATMENT OF INADEQUATELY CONTROLLED ASTHMA (ISPOR 2026) - "A budget impact model (BIM) was developed to estimate the financial implications of introducing budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM) compared with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients advancing to triple therapy from a U.S. payer perspective. The BIM was constructed over a 3-year time horizon in 2025 U.S. dollars for a hypothetical 1,000,000-member health plan... Adding BUD/GLY/FORM led to PMPM savings alongside fewer severe exacerbations and lower exacerbation-related utilization and spending. BUD/GLY/FORM may be a valuable option for payers prioritizing exacerbation prevention in uncontrolled asthma."

HEOR • Asthma • Immunology • Respiratory Diseases

COST-UTILITY ANALYSIS OF FLUTICASONE FUROATE/UMECLIDINIUM/VILANTEROL COMPARED WITH VILANTEROL/UMECLIDINIUM FOR THE REDUCTION OF MODERATE TO SEVERE EXACERBATIONS IN THE TREATMENT OF MODERATE TO VERY SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE IN... (ISPOR 2026) - "FF/UMEC/VI is a cost-effective treatment strategy compared to UMEC/VI for reducing moderate and severe exacerbations in moderate to very severe COPD in Colombia. Results were robust across sensitivity analyses, although sensitive to certain cost variations confirming the favorable economic profile of FF/UMEC/VI within the Colombian healthcare context."

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

Hypercapnic Cerebral Edema Resolved by Noninvasive Ventilation: A Case Report (AAN 2026) - "Design/ NA A 60-year-old man with chronic obstructive pulmonary disease and chronic respiratory failure on home oxygen presented with 4 days of progressive dyspnea, productive cough, and confusion after discontinuing his inhaled fluticasone furoate/ umeclidinium/vilanterol regimen... This case demonstrates hypercapnic global cerebral edema as a reversible entity responsive to NIV. Unlike prior reports requiring intubation and osmotherapy, both encephalopathy and imaging abnormalities resolved rapidly with BiPAP alone. Prompt recognition may avoid unnecessary escalation of care and supports further exploration of NIV in managing hypercapnia-associated cerebral edema."

Case report • Clinical • Non-invasive • Chronic Obstructive Pulmonary Disease • CNS Disorders • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

Is Clinical Remission, an Ambitious Treatment Goal, Achievable in Patients with Moderate-to-Severe Asthma on Inhaled Therapies: How Ambitious Should We Be? (PubMed, J Clin Med) - P3 | "The long-term safety study allocated participants to once-daily FF/UMEC/VI based on asthma control status...At Week 52 in the long-term safety study, equivalent figures for CR achievement were 33-60%, 22-45%, 11-28%, and 11-23%. This analysis demonstrates that CR, using different definitions and criteria, is an attainable treatment goal with inhaled therapy in Japanese patients with moderate-to-severe asthma not yet eligible for biologics."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

VENTURI (VENTilation Using Respiratory Imaging) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Initiation date: Dec 2025 ➔ Mar 2026

Trial initiation date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Economic evaluation of single-inhaler triple therapy for chronic obstructive pulmonary disease in Thailand. (PubMed, BMJ Open Respir Res) - "Our study indicated that SITTs are not cost-effective at the current price compared with the current MITT for COPD treatment. However, FF/UMEC/VI could be a promising option, with an approximately 30% price reduction."

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

A Pragmatic RCT of FF/UMEC/VI in Patients with Uncontrolled Asthma: PERFORM Protocol. (PubMed, Pulm Ther) - "PERFORM is a pragmatic randomised controlled trial generating data relevant to a broad population of patients with uncontrolled asthma representative of routine clinical practice. This trial will also include the first prospective data on clinical remission for patients treated with inhaled therapy."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Royalty Receipts was $856 million in the fourth quarter of 2025, an increase of 17% compared to $729 million in the fourth quarter of 2024. (The Manila Times) - "The increase was primarily driven by Voranigo, Trelegy, Tremfya and the cystic fibrosis franchise, which was partially offset by a decline from Promacta due to U.S. generic competition which launched in May 2025."

Commercial • Aplastic Anemia • Asthma • Astrocytoma • Chronic Obstructive Pulmonary Disease • Crohn's disease • Cystic Fibrosis • Glioma • Immune Thrombocytopenic Purpura • Immunology • Oligodendroglioma • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

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=22 | Completed | Sponsor: Thammasat University | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Trelegy Ellipta approved in China for use in adults with uncontrolled asthma (GSK Press Release) - "The approval means that FF/UMEC/VI is the first and only single inhaler triple therapy (SITT) approved for the maintenance treatment of both respiratory conditions in the country...Approval was based on GSK’s CAPTAIN study which showed that in patients uncontrolled on inhaled corticosteroids/long-acting beta agonist (ICS/LABA), the additional bronchodilation provided by FF/UMEC/VI demonstrated significant improvements in lung function compared with FF/VI."

China approval • Asthma • Immunology

Response to: Letter to the Editor Regarding "Comparative Effectiveness of FF/1 UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up From Dual Therapy". (PubMed, Adv Ther) - No abstract available

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

Letter to the Editor Regarding "Comparative Effectiveness of FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up From Dual Therapy". (PubMed, Adv Ther) - No abstract available

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

FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up from Dual Therapy Stratified by Exacerbations and Prior Dual Therapy: A Subgroup Analysis of a Comparative Effectiveness Study. (PubMed, Adv Ther) - "Patients newly initiating FF/UMEC/VI following prior treatment with ICS/LABA or LAMA/LABA experienced a significantly lower rate of moderate-severe COPD exacerbations than those newly initiating BUD/GLY/FORM irrespective of number of prior exacerbations or prior dual therapy class."

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

Clinical Stability under FF/UMEC/VI Triple Inhaled Therapy: A 12-Month Real Life Retrospective Observational Study. (PubMed, Respir Med) - "This might have a relevant impact in clinical practice, especially in the setting of pulmonary rehabilitation. Nonetheless, further multicenter prospective studies are warranted to validate our findings and to identify predictors of treatment success."

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

Mining of Adverse Event Signals Associated with Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy: A Post-Marketing Analysis Based on FAERS. (PubMed, Pharmacy (Basel)) - "A total of 196 significantly disproportionate preferred terms (PTs) were identified, including previously undocumented AEs such as chronic eosinophilic rhinosinusitis, dysphonia, and vocal cord dysfunction. This post-marketing safety study revealed significant signals for dysphonia and vocal cord dysfunction associated with FF/UMEC/VI, suggesting that clinicians should remain vigilant for these events."

Adverse events • Journal • P4 data • Chronic Obstructive Pulmonary Disease • Dysphonia • Immunology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

Evaluating Asthma Clinical Remission with Inhaled Therapy: Post Hoc Analyses of CAPTAIN. (PubMed, Adv Ther) - P3 | "The results of this post hoc analysis demonstrate that CR is achievable with inhaled therapy in moderate-to-severe asthma and is more likely with FF/UMEC/VI than FF/VI. CR should be considered an attainable treatment goal for patients with asthma, irrespective of disease severity or treatment history."

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

Relative particle size and distribution of inhaled triple therapies. (PubMed, Ann Allergy Asthma Immunol) - "BDP/FF/G delivers consistently smaller particles than either BUD/FF/G or FLU/VI/UMEC, translating into a commensurate higher extrafine particle fraction, in turn suggesting greater potential to target the small airways."

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

TETRIS - Prospective study to observe clinical outcomes of triple therapy in COPD patients: up to 12 months interim analysis. (PubMed, Respir Med) - P | "Overall, SITT dosed OD, specifically FF/UMEC/VI is associated with a significant reduction in hospitalisations due to exacerbations and improvement in symptoms at the 6-month and 1-year follow-up visits."

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

Cost-effectiveness modeling of mortality risk reduction comparing two fixed-dose combination triple therapies in moderate-to-very severe chronic obstructive pulmonary disease. (PubMed, J Comp Eff Res) - "Due to a reduced mortality rate, more patients remained on BGF treatment than on FF/UMEC/VI, which induced higher treatment-related costs; however, the latter was offset by decreased end-of-life costs, as BGF avoided more deaths. BGF may improve health outcomes and reduce healthcare costs compared with FF/UMEC/VI in patients with moderate-to-very severe COPD in a UK setting."

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

VENTURI (VENTilation Using Respiratory Imaging) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Alabama at Birmingham

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Optimizing COPD management in Latin America: a cost-effectiveness analysis of FF/UMEC/VI in Colombia. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "Sensitivity analyses confirmed the robustness of results, with FF/UMEC/VI remaining cost-effective in > 60% of simulations. FF/UMEC/VI is a cost-effective strategy for managing moderate-to-severe COPD in Colombia, offering improved clinical outcomes at an acceptable cost and supporting its adoption in treatment guidelines and reimbursement decisions."

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

Real-World Safety and Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Asthma: Final Analysis of a Post-Marketing Surveillance in Japan. (PubMed, Adv Ther) - "FF/UMEC/VI was well tolerated and effective in the treatment of patients with asthma in Japan. ADRs were reported in 8.4% of patients and the incidence of CV events was low. No new safety concerns were identified."

Journal • P4 data • Real-world evidence • Asthma • Cardiovascular • Cough • Dysphonia • Immunology • Pulmonary Disease • Respiratory Diseases