Anoro Ellipta (umeclidinium/vilanterol) / Innoviva, GSK - LARVOL DELTA

Long-acting β2 agonist (LABA) with a long-acting muscarinic receptor antagonist (LAMA) promotes human airway smooth muscle (HASM) relaxation and circumvents β2 adrenergic receptor tachyphylaxis. (PubMed, Respir Res) - "In primary HASM and human precision-cut lung slices (hPCLS) obtained from non-diseased donors, we show that the combination of umeclidinium (LAMA) and vilanterol (LABA) robustly attenuated carbachol-induced E-C coupling markers, compared to that induced by either compound individually. Furthermore, the umeclidinium-vilanterol combination showed little change in the ability to dilate pre-constricted hPCLS in the presence of albuterol-induced β2AR desensitization compared to relaxation to vilanterol alone, which was significantly attenuated by albuterol-induced desensitization. Our data suggest that targeting Gαq and Gαi signaling through muscarinic receptor antagonism serves as an effective therapy for obstructive lung diseases, even in the face of β2AR tachyphylaxis."

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

Impact of umeclidinium/vilanterol dual bronchodilator therapy on pulmonary function and inflammatory responses in stable COPD patients. (PubMed, Sci Rep) - "This observational study suggests that UMEC/VI dual bronchodilator therapy is associated with superior clinical outcomes and a favorable safety profile in patients with stable moderate COPD. However, these findings require validation through adequately powered randomized controlled trials before definitive therapeutic recommendations can be established."

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

Is dual bronchodilation a cost-effective alternative to ICS/LABA in COPD? A Colombian healthcare system evaluation. (PubMed, Expert Rev Respir Med) - "Although ICS/LABA combinations like fluticasone/salmeterol (FSC) are widely used, dual bronchodilation with umeclidinium/vilanterol (UMEC/VI) may offer clinical and economic advantages. UMEC/VI yielded 8.74 additional QALYs compared to FSC, with an incremental cost of $7,039 USD, resulting in an ICER of $805 per QALY - well below Colombia's WTP threshold of $5,180. Sensitivity analyses confirmed model robustness; UMEC/VI remained cost-effective in 64% of simulations."

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

Late Breaking Abstract - Efficacy and Safety of TQC3403 in Patients with COPD: a Multicenter, Randomized, Open-label, Phase 3 Equivalence Trial (ERS 2025) - "This study reported the equivalence of TQC3403, the first generic umeclidinium/vilanterol DPI, versus ANORO ®...Conclusions Therapeutic equivalence was demonstrated between TQC3403 and ANORO® in lung function improvement, with comparable safety. These findings support TQC3403 as a viable alternative to improve global access to dual bronchodilator therapy."

Clinical • Late-breaking abstract • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Disease stability in COPD with umeclidinium/vilanterol (UMEC/VI) compared to tiotropium (TIO), umeclidinium, and salmeterol (SAL): post hoc analyses of ZEP and EMAX studies (ERS 2025) - "Approximately half of patients receiving UMEC/VI can achieve an improvement/no worsening in a composite endpoint of lung function, exacerbations and symptoms at w12 vs baseline. Across the different therapies evaluated, a proportion of patients were able to maintain their treatment gain as DS at w24."

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

Causal machine learning to investigate heterogeneity in time to first COPD exacerbation for ICS/LABA versus LAMA/LABA (ERS 2025) - P3 | "Background and aim: In the IMPACT trial (NCT02164513), a comparison of the two control arms shows on average no benefit of fluticasone furoate/vilanterol (FF/V, ICS/LABA) over umeclidinium/vilanterol (U/V, LAMA/LABA) in time to first COPD exacerbation (hazard ratio (HR) 0.98, p=0.5). This use case highlights how specific patient profiles may benefit from different treatments, even if on average no effect is observed. Causal ML is a promising tool to uncover such patterns in data from randomized controlled trials."

Heterogeneity • Machine learning • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Comparative in-vitro performance evaluation of two fluticasone furoate/ vilanterol/umeclidinium (100/25/62.5 mcg) multi-dose dry powder inhalers (ERS 2025) - "The delivered dose, FPD, MMAD and GSD of fluticasone furoate, vilanterol and umeclidinium delivered by the two devices were similar at specified flow rates, suggesting similar drug delivery into the lungs under ideal conditions using correct inhaler technique."

Preclinical • Respiratory Diseases

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=48 | Terminated | Sponsor: Fundacio Privada Mon Clinic Barcelona | N=1028 ➔ 48 | Trial completion date: Sep 2025 ➔ Jan 2025 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jan 2025; Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators (clinicaltrials.gov) - P4 | N=72 | Recruiting | Sponsor: University of Tennessee Graduate School of Medicine

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

Single-inhaler triple therapy improves small airway dysfunction in moderate to severe asthma and asthma-COPD overlap: a retrospective cohort study. (PubMed, J Asthma) - "Medium- or high-dose fluticasone furoate (FF)/vilanterol (VI)/umeclidinium (UMEC) is associated with an improvement in forced expiratory volume in one second (FEV1), a marker of large airway dysfunction. Improvements in FEV1, X5, and AX correlated with improvements in ACT, and improvements in FEV1 and FEV1/FVC correlated with improvements in ACQ. FF/VI/UMEC improved SAD, and its improvement was correlated with improved asthma control in moderate to severe asthma and ACO patients."

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

Real-world Effectiveness of Single-inhaler Long-acting Dual Bronchodilators in Chinese Patients With Chronic Obstructive Pulmonary Disease (ATS 2025) - " This single-country (China), single-center, retrospective, non-interventional, real-world study evaluated the effectiveness of Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 µg and Indacaterol/Glycopyrronium (IND/GLY) 110/50 μg, administered once daily, in improving clinical outcomes in COPD patients compared to baseline. This real-world study demonstrated the effectiveness of single-inhaler dual bronchodilators in improving lung function among COPD patients in a practical clinical setting and highlighted the potential to restore impaired lung function after treatment."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Finding the Best Fit: A Head-To-Head Comparison of Triple Therapy Regimens in COPD (ATS 2025) - "This study evaluates the efficacy of two triple therapy regimens — Glycopyrrolate, Budesonide, and Formoterol Fumarate (GLY/BUD/FOR) and Fluticasone Furoate, Vilanterol, and Umeclidinium (FF/VI/UMEC) —in adults aged 45 and older with diagnosed COPD with FEV1/FVC < 70% to assess the impact of these regimens on the preventing COPD exacerbations and acute hypoxemic respiratory failure. Our study suggests that FF/VI/UMEC demonstrated an increased risk of COPD exacerbations and acute hypoxic respiratory failure compared to the group receiving GLY/BUD/FOR. This indicates that GLY/BUD/FOR may provide enhanced protective benefits in patients with moderate to severe COPD, improving disease management and minimizing healthcare resource utilization. Further studies are warranted to explore the long-term benefits and potential mechanisms underlying the observed differences."

Head-to-Head • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Parameter D and Treatment Effects of LAMA/LABA in COPD (ATS 2025) - "Patients newly detected to have COPD (FEV1/FVC<0.70) were prospectively enrolled in a 12-week trial of inhaled LAMA/LABA (umeclidinium bromide/vilanterol trifenatate)... In treatment-naive, screen-detected COPD, change in Parameter D is more strongly correlated with changes in patient-reported outcomes than change in FEV1."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Severe Immune-mediated Pneumonitis Induced by Pembrolizumab (ATS 2025) - "He experienced persistent shortness of breath while walking, lying flat, and bending over but noticed some relief when sitting down and using Anoro Ellipta, a bronchodilator...Despite systemic corticosteroids with methylprednisolone 40 mg IV every 8 hours, the patient demonstrated only slight improvement...The patient's condition improved and was discharged with a new treatment regimen, including home oxygen, Mycophenolate 500 mg BID, and prednisone 40 mg daily, with Pembrolizumab placed on hold with follow-up scheduled with oncology and pulmonology services...Early recognition, prompt diagnosis, and the use of systemic corticosteroids are critical for management. However, in cases where there is an inadequate response, intravenous immunoglobulin may be an effective adjunct therapy, leading to significant clinical improvement."

Asthma • Chronic Obstructive Pulmonary Disease • Cough • Inflammation • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

Cost-Effectiveness of Umeclidinium/Vilanterol Combination Therapy for Group B COPD Patients (ISPOR 2025) - "The results demonstrated the feasibility of UMEC/VI aligning with Thailand’s WTP threshold and being included in the NLEM through price negotiation, thereby increasing access to necessary medicine and subsequently improving clinical outcomes for Group B COPD patients."

Clinical • Combination therapy • Cost effectiveness • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

COPD in elderly patients (PubMed, Pneumologie) - "Substances with a long duration of action, such as fluticasone furoate, vilanterol and umeclidinium, are the best option. This is due to the increase in occlusion capacity, which causes the small airways to collapse earlier. It is essential to consider comorbidities and body position during blood gas sampling to avoid an oversupply of home oxygen therapy in old age."

Journal • Alzheimer's Disease • Cardiovascular • Chronic Obstructive Pulmonary Disease • CNS Disorders • Congestive Heart Failure • Dementia • Gastrointestinal Disorder • Geriatric Disorders • Heart Failure • Immunology • Pulmonary Disease • Respiratory Diseases • Sarcopenia

The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: Mahidol University | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Oct 2024

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

Zydus Healthcare Gets CDSCO Panel Nod To study Vilanterol plus Umeclidinium powder for inhalation (Medical Dialogues) - "Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of the fixed-dose combination (FDC) pulmonary drug Vilanterol 25 mcg plus Umeclidinium 62.5 mcg powder for inhalation. However, this approval is subject to the condition that severe chronic obstructive pulmonary disease (COPD) patients with an inspiratory flow rate of less than 30 liters per minute must be excluded from the study. At the recent SEC meeting for Pulmonary held on 11th March 2025, the expert panel reviewed the proposal along with the Phase III CT protocol of the FDC Vilanterol Trifenatate plus Umeclidinium Bromide Powder for Inhalation."

New P3 trial • Chronic Obstructive Pulmonary Disease

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 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

Comparative effectiveness of olodaterol/tiotropium and vilanterol/umeclidinium among COPD patients: a high-dimensional propensity score matched new user cohort study in a US Medicare population. (PubMed, Expert Rev Respir Med) - "The adjusted hazard ratio of the time to first COPD exacerbation was 0.948 (95% Confidence interval: 0.813-1.105) for individuals initiating OLO/TIO versus VI/UMEC. We did not find a statistically significant difference between the OLO/TIO and VI/UMEC new users in terms of time to first severe exacerbation among Medicare COPD patients aged 65 or older."

HEOR • Journal • Medicare • Reimbursement • US reimbursement • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluation of comparative efficacy of Umeclidinium/Vilanterol versus other bronchodilators in the management of chronic obstructive pulmonary disease: a systematic review and meta-analysis of RCTs. (PubMed, BMC Pulm Med) - "This systematic review and meta-analysis concludes that UMEC and VI combinations are an efficacious treatment option for symptomatic COPD patients."

Clinical • Journal • Retrospective data • Review • Chronic Obstructive Pulmonary Disease • 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: Sep 2024 ➔ Jan 2025

Trial initiation date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • CCL18 • CRP • DEFA1 • LCN2

Effect of dual bronchodilators plus preoperative rehabilitation in operable LC & chronic obstructive pulmonary disease. (PubMed, Future Oncol) - "The group O demonstrated fewer perioperative adverse reactions, and shorter days of postoperative chest tube and hospitalization compared with the group C (p < 0.05). Perioperative inhalation of umeclidinium/vilanterol can effectively protect arterial blood gas and respiratory function in patients with LC complicated with COPD."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor