vilanterol (GW642444H) / GSK - LARVOL DELTA

Effectiveness of indacaterol/glycopyrronium/mometasone for refractory asthmatic cough after switching from inhaled corticosteroid/long-acting β2-agonist therapy. (PubMed, J Allergy Clin Immunol Glob) - "In this multicenter, randomized, open-label, parallel-group study, 118 patients were randomized to receive either IND/GLY/MF or high-dose ICS/LABA (fluticasone/vilanterol [FF/VI] or budesonide/formoterol [BUD/FM]) for 8 weeks. Symptoms improved comparably between medium-dose IND/GLY/MF and high-dose ICS/LABA combinations, although no superiority could be demonstrated. Medium-dose IND/GLY/MF may be an alternative to high-dose ICS/LABA."

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

A Novel Metered Dose Inhaler Formulation of Triple-Drug Fixed-Dose Combination of Vilanterol, Glycopyrronium, and Fluticasone Furoate: A Phase III, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety in Indian Patients With Uncontrolled Asthma. (PubMed, Clin Ther) - "Efficacy and safety of VIL-GLY-FF-MDI were found to be similar to those of IND-GLY-MF-DPI in Indian patients with persistent asthma. Clinical Trial Registry India identifier: CTRI/2024/01/061230."

Journal • P3 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

UNEXPECTED PULMONARY FINDINGS IN A TRAVELER: A CASE OF LATENT TUBERCULOSIS IN AN ELDERLY PATIENT (CHEST 2025) - "was diagnosed with acute bronchitis and treated with albuterol and azithromycin, leading to symptom improvement...He was prescribed intranasal fluticasone, fluticasone/vilanterol inhaler, and tessalon perles, which resolved his symptoms... This case features the importance of screening for LTBI in elderly patients with new-onset pulmonary abnormalities, even if prior TB tests were negative. It emphasizes the increasing role of CT imaging in spotting asymptomatic pulmonary abnormalities that might need further investigation. A multidisciplinary approach is crucial for accurate diagnosis and management."

Clinical • Chronic Cough • Cough • Immunology • Infectious Disease • Mood Disorders • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Applicability domain-expansion studies for machine learning models reveal new inhibitors of CYP2B6. (PubMed, Drug Metab Dispos) - "Additionally, the in vitro experiments identified vilanterol and allylestrenol as inhibitors of CYP2B6 with IC50 values in the sub to low micromolar range. SIGNIFICANCE STATEMENT: CYP2B6 inhibition can affect the metabolism of important drugs, like methadone and propofol, and result in variability that can lead to adverse events. Machine learning models can help uncover new molecules with inhibitory potential against CYP2B6, but only if predictions of these models are reliable. This study illustrates how the intentional expansion of a machine learning model's applicability domain is neither a simple nor straightforward task, but even a conservative effort can reveal new molecules with CYP2B6 inhibition activity."

Journal

Oscillometry as a Diagnostic Tool for Small Airways Obstruction in Symptomatic At-risk Individuals with Normal Spirometry: Baseline Data from the IeCAN Study (ERS 2025) - " Indian Early COPD Assessment Network (IeCAN) study is an, ongoing, multicentric, double-blind, double-dummy, randomized controlled trial evaluating inhaled Vilanterol+Fluticasone versus placebo in symptomatic patients (CAT score>10) with a smoking history of more than 10 pack-years or equivalent biomass fuel exposure in presence of normal spirometry, but with Ax>6 on oscillometry (Tremoflo C100R).After 12 weeks treatment we assessed change in CAT score, Ax & R5-20. Smokers and biomass smoke exposed subjects with significant respiratory symptoms and normal spirometry, show significantly abnormal Ax, R5-20 & X5 values highlighting the role of Oscillometry in the diagnosis of pre- COPD where small airways are affected."

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

Impact of inhaled triple therapy on symptomatic tobacco-exposed individuals with normal spirometry (ERS 2025) - " In this investigator-initiated, interventional trial, symptomatic tobacco-exposed individuals with ≥10pack- year smoking history and FEV1/FVC>0.7 (intervention group) underwent evaluation, including quality-of-life assessments, lung function, computed tomography, and exercise capacity measurements at baseline and after 12 weeks of therapy with ICS(Fluticasone furoate 92mcg), LABA(Vilanterol 22mcg) and LAMA(Umeclidinium 55mcg). Inhaled triple therapy significantly reduces the burden of small airway disease and alleviates symptoms in symptomatic tobacco-exposed individuals with preserved FEV1/FVC ratio."

Clinical • Respiratory Diseases

A Comparison of the Molecular Pharmacological Properties of Current Short, Long, and Ultra-Long-Acting β2-Agonists Used for Asthma and COPD. (PubMed, Pharmacol Res Perspect) - "Few studies directly compare the molecular pharmacological properties of short (salbutamol, terbutaline, fenoterol), long (formoterol, salmeterol), and ultra-long-acting (indacaterol, olodaterol, vilanterol) β2-agonists. Comparison with other β-ligands suggests that affinity and duration could both be improved further. However, given the very wide range of molecular pharmacological properties of β-agonists that are clinically effective and widely used, non-pharmacological properties (physiochemical, patient factors, devices and combination inhaler availability) may be as important in final clinical patient outcomes as the molecular pharmacological properties of the individual β2-agonists themselves."

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

Efficacy and safety of novel fixed dose combination of vilanterol, glycopyrronium, and fluticasone furoate dry powder inhaler: A phase 3, randomized, non-inferiority trial compared with fixed dose combination of indacaterol, glycopyrronium, and mometasone furoate dry powder inhaler in Indian asthma patients. (PubMed, Respir Med) - "VIL-GLY-FF DPI was found non-inferior to IND-GLY-MF DPI in improving trough FEV1 response. The test FDC was well-tolerated in Indian patients with persistent asthma."

Head-to-Head • Journal • P3 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Single-Inhaler Triple Therapy Is Useful for Achieving Clinical Remission in Patients With Bronchial Asthma by Improving Asthma Control Test Scores (ATS 2025) - "The Japan Asthma Society has proposed clinical remission (CR) as the treatment goal for bronchial asthma. Based on their medical records, bronchial asthma patients who were newly prescribed fluticasone furoate 200 / umeclidinium bromide / vilanterol trifenatate (FF (200) / UMEC / VI) at our hospital by the end of August 2024 were investigated. FF (200) / UMEC / VI can contribute to the achievement of CR in patients with bronchial asthma."

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

Evaluation of Patient-Reported Outcomes (PRO) and Satisfaction With Once-daily Vilanterol/Fluticasone Furoate (VI/FF) in Uncontrolled Asthma Patients Experiencing Frequent Exacerbations on Conventional Treatment: Sub Group Analysis of a Real World Study (ATS 2025) - "Patients with uncontrolled asthma experiencing frequent exacerbations on conventional therapy showed high adherence to treatment when switched to VI/FF. This adherence was linked to increased patient satisfaction & significant improvement in asthma symptoms, indicating VI/FF a promising option for this group."

Clinical • Patient reported outcomes • Real-world • Real-world evidence • Asthma • Cough • Immunology • Pain • Respiratory Diseases

Economic Evaluation of Single-Inhaler Extrafine Beclometasone Dipropionate/formoterol fumarate/glycopyrronium (Trimbow®) in Adult Patients with Uncontrolled Asthma in Mexico (ISPOR 2025) - "The annual per-patient cost for BDP/FF/G was $3,881.34, compared to Beclometasone/Formoterol ($4,373.36), Budesonide/Formoterol ($6,098.29), Salmeterol/Fluticasone ($14,014.57), and Fluticasone/Vilanterol ($14,096.49). The extrafine SITT with BDP/FF/G is a dominant therapeutic option for adults with uncontrolled asthma in Mexico, delivering superior asthma control, significantly reducing exacerbations, and lowering annual per-patient costs compared to therapies currently used by IMSS."

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases

Inhalation Safety and Tolerability of a Novel Fixed Dose Combination of Glycopyrronium-Vilanterol Powder in Wistar Rats. (PubMed, Toxicol Mech Methods) - "Minimal, non-dose-related microscopic lesions and normal alveolar macrophage responses were observed. The No-Observed-Adverse-Effect Level (NOAEL), based on actual concentration and duration of exposure, was established at 25 + 50 mcg/kg/day, indicating the FDC's safety and suitability for further development in COPD management."

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

U-LABA/ICS Effects on Exercise Performance, Vilanterol (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Morten Hostrup, PhD | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date

Role of Lung Function for Exercise Capacity in Well-trained Individuals (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Morten Hostrup, PhD | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Inflammation • Respiratory Diseases

Efficacy and safety of maintenance regimens for adolescent and adult asthmatics with exercise-induced bronchospasm: Systematic review and network meta-analysis. (PubMed, J Allergy Clin Immunol Pract) - "Low-dose ICS and as-needed ICS-formoterol were equally effective in managing asthmatics with EIB. Adding anti-leukotrienes or LABA to ICS should be considered for more severe cases, with close monitoring to assess treatment response and detect potential tachyphylaxis or AEs."

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

Green Approach for Simultaneous Determination of Long Acting β-Agonists, their Organic Counterparts and Corticosteroids by HPLC Coupled with PDA Detector. (PubMed, Ann Pharm Fr) - "The proposed method was accurate, precise and robust and results were within the limit as per the ICH (Q2R1) guidelines. Additionally, the proposed method was found to be green and sustainable when analysed by different green analytical tools namely GAPI, AGREE, AGREEprep and BAGI."

Journal

Repurposing FDA-Approved Drugs for Eumycetoma Treatment: Homology Modeling and Computational Screening of CYP51 Inhibitors. (PubMed, Int J Mol Sci) - "Current treatments, including antifungal drugs like itraconazole, often show variable efficacy, with severe cases necessitating surgical intervention or amputation. To this end, a library of 2619 FDA-approved drugs was screened, identifying three promising candidates: montelukast, vilanterol, and lidoflazine. These compounds demonstrated favorable binding affinities, strong interactions with critical residues of the homology model of Madurella mycetomatis CYP51, and stability in molecular dynamics simulations, offering potential for further investigation as effective therapeutic options for eumycetoma."

FDA event • Journal • Infectious Disease • Oncology

A CASE OF IgG4-RELATED DISEASE WITH CONFIRMED RESPONSE TO DUPILUMAB BY SMALL SALIVARY GLAND BIOPSY (PubMed, Arerugi) - "Fluticasone-vilanterol was introduced, but there was little improvement in the cough. In addition, serum IgG4 levels decreased after the initiation of dupilumab treatment, and a decrease in IgG4-positive plasma cells was observed on small salivary gland biopsy. Thus, the treatment of inhaled steroid-resistant bronchial asthma with dupilumab can also improve IgG4-related disease, and we confirmed a decrease in IgG4-positive plasma cells in the small salivary glands."

Biopsy • Journal • Asthma • Cough • Immunology • Inflammation • Oncology • Pulmonary Disease • Respiratory Diseases • Small Intestinal Carcinoma

In Vitro Analysis of Aerodynamic Properties and Co-Deposition of a Fixed-Dose Combination of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate. (PubMed, Pharmaceutics) - "Spatial distribution and abundance of ICS/LABA/LAMA in the same cascade levels were closely comparable, and the aerosol particles were able to reach the small aerosol-sized cascades at the lower levels to some extent."

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

Sub-Optimal Compliance to Long-Term Inhalation Strategies and Poorer Health Care Outcomes Associated with Extended Tattoos in Adolescents with Mild-to-Moderate Bronchial Asthma. (PubMed, Children (Basel)) - "Tattoo extension might be used as a reliable predictor of poor compliance and higher health care costs in adolescents with mild-to-moderate asthma. Patients characterized by poor compliance to a long-term therapeutic strategy and tattooing attitude likely share some aspects of their personality profile."

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

Clinical benefits with Fluticasone furoate/Umeclidinium/Vilanterol therapy for COPD: post hoc subgroup analysis of ELLITHE study (ERS 2024) - "In COPD patients of this ELLITHE subanalysis, odSITT improved CAT score independent of specified baseline criteria. Despite overlap in response, individual outcome assessments are necessary to fully comprehend differential benefits of real-world odSITT beyond exacerbations."

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

β2-agonists induce and augment rhinovirus-induction of pro-inflammatory mediators in bronchial epithelial cells. (ERS 2024) - "Methods BEAS-2B BECs were stimulated with vehicle control or 0.1-100nM of short-acting or long-acting β2-agonists (LABAs), ultra-LABAs and short or long-acting muscarinic antagonists; +/- rhinovirus(RV)-A16 infection to mimic use during exacerbations; +/- 10nM fluticasone propionate (furoate with vilanterol)...This may explain the adverse effects associated with β2-agonist use without ICS. In vivo studies need to determine the clinical significance of these findings."

Asthma • Immunology • Infectious Disease • Respiratory Diseases • BDNF • IL6

CD64+ fibroblast-targeted vilanterol and a STING agonist augment CLDN18.2 BiTEs efficacy against pancreatic cancer by reducing desmoplasia and enriching stem-like CD8+ T cells. (PubMed, Gut) - "Vilanterol plus the STING agonist sensitised PDAC to CLDN18.2 BiTEs and augmented efficacy as a potential novel strategy."

Journal • Fibrosis • Gastrointestinal Cancer • Hepatology • Immunology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CAFs • CD8 • CLDN18 • RHOA • STING • SYK

Comparison of Budesonide/formoterol versus Fluticasone furoate/vilanterol as maintenance and reliever therapy for asthma control: a real-world observational study. (PubMed, BMC Pulm Med) - "In the current study, patients treated with FF/VIL as MART showed improvements in ACT scores, while those treated with BUD/FOR as MART exhibited a reduction in FeNO levels. However, the difference between the two treatment groups did not reach clinical significance. Thus, FF/VIL as MART showed similar effectiveness to BUD/FOR as MART."

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

Comparison of the Genomic Activity of an EP4-Receptor and β2-Adrenoceptor Agonist in BEAS-2B Human Bronchial Epithelial Cells: In Search of Compartmentalized, cAMP-dependent Gene Expression. (PubMed, J Pharmacol Exp Ther) - "Herein, we used mRNA-seq to compare the transcriptomic responses produced by ONO-AE1-329 (an EP4-receptor agonist) and vilanterol (a β2-adrenoceptor agonist) in BEAS-2B human airway epithelial cells...Furthermore, ONO-AE1-329 behaved as a partial agonist that varied across transcripts. If this genomic activity is reproduced in vivo, then EP4-receptor agonists could represent an alternative, and possibly safer, class of bronchodilators."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases