Breo Ellipta (fluticasone furoate / vilanterol) / GSK, Innoviva - LARVOL DELTA

Role of Oscillometry and Therapeutic response to Fluticasone/Vilanterol in pre COPD: A randomized, double blind, placebo controlled trial (ERS 2026) - "Subjects with Pre COPD defined as AX>6 cmH2O/L.s when treated with FF/V showed significant improvements in CAT score and lung elastance measured by AX."

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

Deposition of three dry powder aerosol drugs in the airways of severe asthma patients undergoing biological therapy (ERS 2026) - "This study aimed to quantify the deposition patterns of the fixed‑combination dry powder inhalers Symbicort® Turbuhaler®, Foster® NEXThaler®, and Relvar® Ellipta® in the airways of these patients. Conclusions The vast majority of severe asthmatics receiving biologic therapy were able to generate inhalation parameters sufficient to achieve an adequate delivered lung dose. Overall, patients with lower PIF values through the inhaler achieved higher lung deposition with Relvar and Foster, while those with high PIF values obtained the greatest lung doses with Foster and Symbicort."

Clinical • Asthma • Immunology • Respiratory Diseases

Current perspectives on β2-adrenergic receptor agonists in asthma: navigating from track to track within GINA recommendations. (PubMed, Expert Opin Pharmacother) - "Contemporary trials and real-world studies reveal many patients on SABA-centered or fluticasone furoate/vilanterol regimens may reach these exposure levels, whereas ICS/formoterol regimens produce lower reliever use and fewer exacerbations. Where ICS/formoterol is accessible, Track 1 should be the default strategy. Clinicians should minimize SABA overuse, prioritize ICS/formoterol regimens, and advocate policies improving access to reduce preventable morbidity and mortality."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Impact of Fluticasone Furoate/Vilanterol on Small Airway Function in Asthma: A Real- World Study Using Impulse Oscillometry Stratified by Eosinophilic Inflammation. (PubMed, J Asthma Allergy) - "Improvements in small-airway mechanics were observed in patients with lower eosinophilic inflammation, suggesting that eosinophilic inflammation may be associated with attenuated small airway response. Further prospective studies are warranted to better define the role of inflammatory status in small airway dysfunction and to validate these findings."

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

Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Sandoz | N=1430 ➔ 0 | Trial completion date: Oct 2026 ➔ Apr 2026 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Oct 2026 ➔ Apr 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Asthma • 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

An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD). (PubMed, Cureus) - "FF/VI DPI demonstrated significant improvements in lung function and asthma control with high patient satisfaction and a favorable safety profile, establishing it as a promising maintenance therapy for asthma management in Indian patients."

Journal • P4 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Fluticasone- vs Budesonide-Based Dual Therapy for COPD. (PubMed, JAMA Netw Open) - "In this cohort study of new ICS-LABA users with COPD, once-daily dry powder fluticasone furoate-vilanterol inhalers were associated with slightly improved clinical outcomes compared with twice-daily metered-dose budesonide-formoterol inhalers and twice-daily dry powder fluticasone propionate-salmeterol inhalers. Further studies are needed to explore potential intraclass differences among inhalers used to treat COPD."

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

Oscillometry Helps Diagnose Pre-COPD and Fluticasone/ Vilanterol Could Help Treat It: Results From Indian Early COPD Network Pilot Study (ATS 2026) - No abstract available

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

SAN-1138: A randomized, double-blind, placebo-controlled clinical endpoint bioequivalence study to evaluate the therapeutic equivalence and safety of fluticasone furoate and vilanterol inhalation powder) 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in participants with asthma (clinicaltrialsregister.eu) - P2/3 | N=120 | Sponsor: Sandoz Private Limited

New P2/3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma (clinicaltrials.gov) - P3 | N=1430 | Not yet recruiting | Sponsor: Sandoz | Initiation date: Jan 2026 ➔ Apr 2026

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

Impact of pharmacotherapy with inhaled corticosteroids and long-acting beta-2 agonists on symptom control and oscillometry parameters among Indian patients with early COPD due to smoking and non-smoking causes: indian pre COPD assessment network (IeCAN) study (BTS WM 2025) - "Participants underwent HRCT, received salbutamol inhaler as needed and randomized to once-daily Fluticasone Furoate/Vilanterol or placebo...Pre-COPD can potentially be defined in at risk patients with normal spirometry if they have CAT>10 and Ax>10. A larger study is needed to assess whether these findings are reproducible and generalisable."

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

The Centers for Medicare and Medicaid Services on Tuesday announced lower prices on…costly prescription drugs under Medicare… (MSN News) - "Here are the negotiated prices for the drugs, based on a 30-day supply, compared to the 2024 list price:...(i) Trelegy Ellipta, an asthma treatment: $175, down from $654...; (ii) Ofev, for idiopathic pulmonary fibrosis: $6,350, down from $12,622...; (iii) Breo Ellipta, a COPD drug: $67, down from $397."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis

Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma (clinicaltrials.gov) - P3 | N=1430 | Not yet recruiting | Sponsor: Sandoz

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

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

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

Comparative Effectiveness of Fixed-Dose ICS/LABA Therapy in Adult Patients with Asthma. (PubMed, Ann Allergy Asthma Immunol) - "The findings suggest that fluticasone furoate/vilanterol may offer a potential advantage for asthma management compared to other fixed-dose ICS/LABA combinations."

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

The Combined Impact of Omalizumab and Allergen Immunotherapy (AIT) in Severe Asthma. (ERS 2025) - " Three women (mean age: 23) with childhood-onset asthma previously treated with inhaled corticosteroid and long- acting beta-2 agonist (fluticasone furoate/vilanterol, 184/22 mcg once daily), tiotropium bromide (5 mcg once daily), montelukast and nasal corticosteroids. Omalizumab pre-treatment improves symptom control and facilitates AIT implementation. In this series of patients, combination therapy increased efficacy, reduced drug use and sustained asthma control even after omalizumab discontinuation."

Asthma • Immunology • Respiratory Diseases

Real-World Comparative Effectiveness Study in Patients with Asthma Initiating Fluticasone Furoate/Vilanterol or Beclometasone Dipropionate/Formoterol Fumarate in General Practice in England. (PubMed, Adv Ther) - "Overall, patients initiating FF/VI and BDP/FOR had numerically similar exacerbation rates; of the patients continuing 12 months' uninterrupted treatment, the FF/VI group had a lower exacerbation rate versus BDP/FOR. Patients initiating FF/VI were less likely to discontinue treatment than those initiating BDP/FOR."

HEOR • Journal • Real-world evidence • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • 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

Real-world evidence (RWE) study on clinical outcomes in asthma: fluticasone furoate/vilanterol (FF/VI) versus (vs) budesonide/formoterol (BUD/FOR) (ERS 2025) - "Results Exacerbation rate for FF/VI was numerically similar vs BUD/FOR in the patient population on initiated treatment 2 , lower in the population when outcome was measured until an event1, and significantly lower among patients who continued uninterrupted treatment for 1 year 3 (FF/VI n=425; BUD/FOR n=546; Table ). Conclusion Patients on FF/VI had fewer exacerbations vs those on BUD/FOR after uninterrupted treatment for 1 year."

Clinical • Clinical data • HEOR • Real-world • Real-world evidence • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Real-world evidence (RWE): asthma clinical-outcomes, fluticasone furoate/vilanterol (FF/VI) versus (vs) beclometasone dipropionate/formoterol (BDP/FOR) (ERS 2025) - "Results Patients initiated on FF/VI had a numerically similar exacerbation rate vs BDP/FOR in the patient population on initiated treatment 2 , lower in the population when outcome was measured till an event 1 , and significantly lower among patients continuing treatment for 1 year without interruption 3 (FF/VI [n=384] vs BDP/FOR [n=3342]; Table ). Conclusion After uninterrupted treatment for 1 year, FF/VI was associated with fewer exacerbations vs BDP/FOR."

Clinical • Clinical data • HEOR • Real-world • Real-world evidence • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Real-world Comparative Effectiveness in Patients with Asthma Newly Initiating Fluticasone Furoate/Vilanterol or Budesonide/Formoterol: A United Kingdom General Practice Cohort Study. (PubMed, Pulm Ther) - "Patients who continued initiation treatment for a year without interruption had reduced exacerbation rates with FF/VI versus BUD/FOR. The FF/VI group also had reduced treatment discontinuation and OCS use."

HEOR • Journal • Real-world evidence • Asthma • 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

Abnormal Lung Infections in an Immunocompetent Patient - Middle Lobe Syndrome (ATS 2025) - "She was switched from fluticasone/vilanterol inhaler to beclomethasone dipropionate and fluticasone/umeclidinium/vilanterol inhalers and underwent pulmonary function testing and chest CT...She was restarted on levofloxacin for a prolonged course and scheduled for bronchoscopy...She underwent balloon dilation and dexamethasone injection of the RML...In this patient, she had a documented history of collapse but was otherwise treated for asthma for 6 years before transferring her care to a tertiary care center. As with all treatment resistant patients, revisiting their original diagnosis may reveal a separate clinical entity that can warrant radical change to treatment plan."

Clinical • Asthma • Chronic Cough • Cough • Fibrosis • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases