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

CHHEF: Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure (clinicaltrials.gov) - P4 | N=60 | Completed | Sponsor: Luis Puente Maestu | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ May 2026 | Trial primary completion date: Dec 2024 ➔ May 2026

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Phase IV, single-center, double-blind, randomized, placebo-controlled, crossover clinical trial designed to evaluate the effect of double bronchodilation with umeclidinium/vilanterol in patients with COPD, hyperinflation, and heart failure. (ERS 2026) - "Significant amelioration of lung hyperinflation and dyspnea and meaningful improvements in exercise parameters were also noted. umeclidinium/vilanterol significantly improves cardiac function during exercise in patients with COPD and left ventricular dysfunction Funded: by an unconditional grant by GSK, SEPAR and Neumomadrid"

Clinical • Late-breaking abstract • P4 data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Respiratory Diseases

Comparative efficacy of once-daily LAMA/LABA combinations versus tiotropium on constant-work-rate cycle endurance in COPD: a randomized crossover pilot study (COMPETE) (ERS 2026) - "Four treatments were administered in a randomized order (28 days each, 7-day washout): tiotropium/olodaterol, umeclidinium/vilanterol, indacaterol/glycopyrronium, and tiotropium. We demonstrate that head-to-head CWRCE method can be a useful test for assessing the effect of individual medications and their combinations on exercise tolerance. The high interpatient variability highlights the potential for personalized bronchodilator selection based on CPET, justifying further study in larger cohorts."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Trends in the Use and Costs of Medications for Respiratory Management Included in the 2022 Benefit Plan of the Colombia Health System. (PubMed, Drugs Real World Outcomes) - "After the 2022 Benefit Plan update for respiratory conditions such as asthma and chronic obstructive pulmonary disease, increases in the dispensing and direct pharmaceutical costs of the newly included therapies were observed. These temporal changes suggest modifications in prescribing and dispensing patterns, potentially reflecting greater access to recommended first-line therapies, although causal attributions to the Benefit Plan update cannot be established, given the descriptive nature of this study."

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

Efficacy and safety of TQC3403 in patients with chronic obstructive pulmonary disease (COPD): a multicenter, randomized, open-label, phase 3 equivalence trial. (PubMed, J Thorac Dis) - P=N/A | "This study aimed to evaluate the clinical equivalence between TQC3403 [the first generic umeclidinium/vilanterol (UMEC/VI) dry powder inhaler (DPI)] and ANORO®...TQC3403 demonstrated clinical equivalence to ANORO® with respect to efficacy, safety, and tolerability in patients with COPD, supporting its clinical use as an effective and well-tolerated alternative for this population. The clinical research was registered at Chinese Clinical Trial Register (Ref: ChiCTR2600120078)."

Journal • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparative Real-World Effectiveness of Fixed-Dose Triple Therapy Regimens in COPD: A Retrospective Cohort Study. (PubMed, J Clin Med) - "We compared real-world clinical outcomes among adults with COPD receiving fluticasone furoate/vilanterol/umeclidinium (FF/VI/UMEC) or budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR)... In this large propensity score-matched real-world cohort study, patients receiving BUD/GLY/FOR experienced lower rates of COPD exacerbations and acute respiratory failure than those receiving FF/VI/UMEC. Because of the retrospective observational nature of the analysis, these findings should be considered hypothesis-generating and require confirmation in prospective comparative effectiveness studies."

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

GSK is expanding its partnership with Chia Tai Tianqing Pharmaceutical Group…by granting the company China commercialization rights for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) and Anoro Ellipta (umeclidinium/vilanterol; UMEC/VI) (AllSci Corp) - "The agreement extends the companies’ May 2026 collaboration around the hepatitis B candidate bepirovirsen into respiratory medicine, creating a multi-product partnership spanning two therapeutic areas. Trelegy and Anoro generated combined global sales of GBP 3.54 billion (approximately USD 4.5 billion) in 2025. Financial terms were not disclosed. Under the agreement, CTTQ will purchase finished product from GSK and book China sales revenue, following the same commercialization and supply model used in the earlier bepirovirsen collaboration."

Licensing / partnership • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Effect of once-daily ICS/LAMA/LABA triple therapy versus ICS/LABA on respiratory symptoms (E-RS: Asthma): Analysis of the phase IIIA CAPTAIN trial. (PubMed, J Allergy Clin Immunol Glob) - "Addition of the long-acting muscarinic antagonist umeclidinium (UMEC) to the inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination fluticasone furoate/vilanterol (FF/VI) improved lung function in adults with uncontrolled moderate to severe asthma in the CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) study; however, the impact on symptoms requires further investigation...The CAPTAIN study was a phase IIIA, randomized, controlled, 24- to 52-week study of patients with uncontrolled moderate to severe asthma despite ICS/LABA receiving once-daily single-inhaler FF/VI (100/25 or 200/25 μg) or FF/UMEC/VI (100/31.25/25, 100/62.5/25, 200/31.25/25, or 200/62.5/25 μg)...Similar trends were observed irrespective of type 2 status. Patients with symptomatic asthma may benefit from optimized treatment interventions, such as adding a long-acting muscarinic antagonist to ICS/LABA."

Journal • P1/2 data • P3 data • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery (clinicaltrials.gov) - P3 | N=204 | Active, not recruiting | Sponsor: Samsung Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ Sep 2026 | Trial primary completion date: Nov 2023 ➔ Apr 2026

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Breztri Aerosphere for asthma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Analysis of Current Status and Influencing Factors of Inhaler Treatment Adherence Among COPD Patients. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Patients using fluticasone furoate/vilanterol/umeclidinium bromide inhalation powder had higher overall adherence than those using budesonide/formoterol fumarate inhalation powder. Lower PDC was observed in newly diagnosed patients and those without a history of acute exacerbations. In clinical practice, greater emphasis should be placed on medication education and long-term management for these patients."

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

Safety analysis of long-acting dual bronchodilator after market approval: a real-world study from FDA Adverse Event Reporting System (FAERS) database. (PubMed, J Thorac Dis) - "This study evaluated post-marketing safety signals for four dual bronchodilators (formoterol/glycopyrronium, indacaterol/glycopyrronium, vilanterol/umeclidinium, and olodaterol/tiotropium). Olodaterol/tiotropium showed signals for ileus, retinal vein occlusion, cataract, and hip fracture, and exhibited the longest latency period among the other three bronchodilators. This pharmacovigilance study identified significant safety signals associated with four bronchodilators, highlighting both common and drug-specific disproportionality signals and thereby providing essential evidence to support drug monitoring in clinical practice."

Adverse events • FDA event • Journal • Real-world evidence • Cardiovascular • Cataract • Chronic Obstructive Pulmonary Disease • Coronary Artery Disease • Immunology • Musculoskeletal Diseases • Myocardial Infarction • Ophthalmology • Orthopedics • Pulmonary Disease • Respiratory Diseases • Retinal Vein Occlusion

Adherence to LAMA/LABA therapies in middle-aged patients with chronic obstructive pulmonary disease: A group-based trajectory analysis. (PubMed, Respir Investig) - "Middle-aged patients with COPD initiating LAMA/LABA therapy exhibited distinct adherence trajectories. Understanding these patterns may help inform more targeted approaches to support adherence and improve patient outcomes."

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

CHHEF: Effect of dual bronchodilation with umeclidinium/vilanterol on patients with COPD, hyperinflation and heart failure (clinicaltrialsregister.eu) - P4 | N=60 | Recruiting | Sponsor: Hospital General Universitario Gregorio Maranon | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Pulmonary Disease • Respiratory Diseases

Determination of Particle Size of Active Pharmaceutical Ingredients in Dry Powder Inhaler Formulations. (PubMed, Pharmaceuticals (Basel)) - " The methodology was successfully applied to Spiriva®, Anoro® Ellipta, and Relvar® Ellipta inhalation powders, revealing micronized APIs with distinct morphological features and verifying systematic application across products. Cross-validation against laser diffraction measurements of pure APIs demonstrated statistical equivalence, confirming the robustness and analytical utility of the proposed method for particle size assessment in DPI formulations."

Journal

COMPETE: Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD (clinicaltrials.gov) - P=N/A | N=100 | Suspended | Sponsor: Medical University of Bialystok

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

Temporal and Partial Reversal of Airflow Limitation in Patients With COPD Treated With Single-Inhaler Long-Acting Dual Bronchodilators. (PubMed, Clin Respir J) - "This study demonstrated significant and sustained improvements in lung function in this real-world cohort of COPD patients managed with LABA/LAMA monotherapy. A subset of patients achieved a posttreatment FEV1/FVC ratio above 70%, indicating a potentially meaningful change in airflow limitation after LADB therapy."

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

Efficacy of single-inhaler triple therapies for chronic obstructive pulmonary disease: a systematic review and network meta-analysis. (PubMed, BMC Pulm Med) - No abstract available

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

Meds from…GSK now offered through TrumpRx DTC platform (Fierce Pharma) - "GSK... is offering DTC discounts on several of its Ellipta inhalers...through the platform....GSK’s Anoro Ellipta comes with a 49% DTC discount. Arnuity Ellipta is between 51-54% lower than its list price through the platform, while the cash price for Incruse Ellipta is 55% lower."

Commercial • Chronic Obstructive Pulmonary Disease

Negotiations with participating drug companies will occur in 2026 and any negotiated and renegotiated prices will become effective January 1, 2028. (CMS Press Release) - "The selected drug list for the third cycle of negotiations is: Anoro Ellipta...Botox; Botox Cosmetic; Cimzia; Cosentyx; Entyvio...Orencia...Trulicity....Xeljanz; Xeljanz XR; Xolair."

Medicare • Allergy • Ankylosing Spondylitis • Asthma • Chronic Obstructive Pulmonary Disease • Crohn's disease • Idiopathic Arthritis • Immunology • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Comparative Effectiveness and Safety of LAMA-LABA Inhalers in Chronic Obstructive Pulmonary Disease. (PubMed, JAMA Intern Med) - "This cohort study found that umeclidinium-vilanterol was associated with improved clinical outcomes compared with glycopyrrolate-formoterol and tiotropium-olodaterol. Patients, prescribers, and health systems may consider once-daily umeclidinium-vilanterol dry powder inhalers over alternatives among new users of LAMA-LABA therapy."

HEOR • Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Nephrology • Pneumonia • Pulmonary Disease • Respiratory Diseases

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

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