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

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

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

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

Effectiveness of ICS/LABA and LAMA/LABA in COPD due to biomass. (PubMed, ERJ Open Res) - "The purpose of the study was to compare the efficacy of fluticasone furoate/vilanterol (FF/V) 100/25 μg and umeclidinium/vilanterol (UMEC/VI) 62.5/25 μg on the rate of exacerbations, the time to first exacerbation, on dyspnoea, health-related quality of life (HRQL), forced expiratory volume in 1 s (FEV1) and inspiratory capacity (IC) during a period of 6 months in patients with COPD-B and COPD-C, at a third level referral centre in Mexico City. All groups showed improvement in dyspnoea and HRQL, independently of medication used. Among patients with COPD-B and COPD-C with a history of exacerbation, FF/VI was equally effective as UMEC/VI in preventing exacerbations and improving dyspnoea and HRQL."

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

Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics (clinicaltrials.gov) - P2 | N=95 | Active, not recruiting | Sponsor: University of Virginia | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ Jan 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2023

Biomarker • Enrollment closed • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

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

Benefit of dual bronchodilator therapy on exacerbations in former and current smokers with chronic obstructive pulmonary disease in real-world clinical practice: a multicenter validation study (TOReTO). (PubMed, Respir Res) - "The three fixed-dose combinations of LABA/LAMA showed no difference in reducing exacerbations in former smokers but did show differences in current smokers. This trend has clinical significance, and future research will be conducted to control influencing variables to validate this point. However, due to the non-randomized study design, these findings should be interpreted with caution."

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

SERUM SICKNESS-LIKE REACTION SECONDARY TO OMALIZUMAB (CHEST 2024) - "Her medications include a fluticasone, umeclidinium, and vilanterol inhaler, fexofenadine, omeprazole, and monthly omalizumab injections, which she has been taking for the past four years...Her respiratory symptoms dramatically improved after three doses of tezepelumab... Serum-sickness like reactions are hypersensitivity reactions which can be seen with biologic therapies. Physicians should have a high index of suspicion when patients have arthralgias and constitutional symptoms temporally associated with exposure to these medications."

Allergic Bronchopulmonary Aspergillosis • Asthma • Cough • Dermatology • Food Hypersensitivity • Immunology • Musculoskeletal Pain • Nephrology • Pain • Respiratory Diseases • Urticaria • Vasculitis

SMOKING-RELATED DIFFUSE CYSTIC LUNG DISEASE (CHEST 2024) - "There are no current treatment guidelines, so we are treating the patient by way of smoking cessation, daily umeclidinium bromide/vilanterol, and follow-up imaging and lung function testing in 6 months... This case represents the difficulty in diagnosing DCLD's and brings to light a rare diagnosis that can mimic other DCLDs. When evidence of cystic lung disease is evident on imaging, physicians must not jump to conclusions and instead pursue further workup by means of laboratory testing and biopsy."

Chronic Obstructive Pulmonary Disease • Fibrosis • Immunology • Infectious Disease • Inflammation • Interstitial Lung Disease • Langerhans Cell Histiocytosis • Nicotine Addiction • Pneumonia • Pulmonary Disease • Respiratory Diseases • Sarcoidosis • Solid Tumor • Tobacco Cessation

THE QUADRUPPLE THREAT: UNRAVELING THE COMPLEXITIES OF ALPHA-1 ANTITRYPSIN DEFICIENCY (CHEST 2024) - "Treatment was initiated with AAT supplementation (Prolastin), COPD management including a umeclidinium bromide/vilanterol inhaler, supplemental oxygen, and pulmonary rehabilitation, which markedly improved her symptoms and pulmonary function. This case highlights the rare and unusual manifestations of AATD in a single patient, emphasizing the potential for late-life diagnosis and the increased risk of lung cancer, sinusitis, and iatrogenic pneumothorax associated with the condition."

Alpha-1 Antitrypsin Deficiency • Asthma • Bronchiectasis • Cardiovascular • Chronic Obstructive Pulmonary Disease • Cough • Genetic Disorders • Hepatology • Hypertension • Immunology • Lung Cancer • Oncology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Solid Tumor • Squamous Cell Carcinoma • Vasculitis • SERPINA1

THE PERENNIAL PNEUMONIA: A CASE REPORT OF ORGANIZING PNEUMONIA SECONDARY TO CHRONIC ASPIRATION FOLLOWING ROUX-EN-Y GASTRIC BYPASS (CHEST 2024) - "Her home medications included fluticasone, umeclidinium, and vilanterol inhalers, prednisone 2.5 mg daily, and mepolizumab injections...At this point, antibiotics were discontinued, and she was started on methylprednisolone 1g daily for three days with trimethoprim-sulfamethoxazole for pneumocystis jiroveci pneumonia prophylaxis... In summary, recurrent aspiration following RYGB represents a unique presentation of secondary OP where definitive treatment is pivotal for the avoidance of redundant courses of antibiotic and corticosteroid therapy which may further heighten symptom burden."

Bariatric surgery • Case report • Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Gastroenterology • Gastroesophageal Reflux Disease • Immunology • Infectious Disease • Inflammation • Interstitial Lung Disease • Pneumonia • Respiratory Diseases

Machine learning models for different outcomes to better understand individual treatment response on COPD exacerbations in the IMPACT study (ERS 2024) - P3 | "Aim: We aimed to develop a machine learning model, trained for time to first COPD exacerbation, to estimate individual treatment response to fluticasone furoate (FF) in addition to umeclidinium/vilanterol (U/V) in the IMPACT trial (NCT02164513), and compared this with a previous model for exacerbation rate. Combining models for different outcomes may better identify absolute treatment response versus nonresponse on individual patient level."

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

Comparison table: Inhaled drugs for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tobacco Cessation

Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure (clinicaltrials.gov) - P4 | N=128 | Recruiting | Sponsor: National Institute of Respiratory Diseases, Mexico

New P4 trial • 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

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • CCL18 • CRP • DEFA1 • LCN2

Safety of umeclidinium/vilanterol in Chinese patients in a real-world setting: a prospective, multicenter, single-arm, observational study (PubMed, Zhonghua Jie He He Hu Xi Za Zhi) - "Three participants (0.3%) reported AEs that were part of serious identified/potential hazards, all of which were considered by the investigators to be unrelated to umeclidinium/vilanterol. The results of this study showed that umeclidinium/vilanterol was well tolerated in Chinese participants in a real-world setting and no new drug-related safety signals were observed."

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

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 | Not yet recruiting | Sponsor: Mahidol University

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

He's Full of Cysts! A Case of Cystic Bronchiectasis (ATS 2024) - "Past medical history includes COPD on umeclidinium/vilanterol, prostate cancer in remission, and former tobacco use...He completed a course of ceftriaxone and azithromycin for suspected community acquired pneumonia and was titrated off supplemental oxygen...He was treated with standard of care for non-CF bronchiectasis and had symptomatic improvement. This case report highlights the dramatic presentation of cystic bronchiectasis and differentiating characteristics as compared to DCLD."

Clinical • Allergic Bronchopulmonary Aspergillosis • Alpha-1 Antitrypsin Deficiency • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Cough • Cystic Fibrosis • Eosinophilia • Fibrosis • Genetic Disorders • Genito-urinary Cancer • Human Immunodeficiency Virus • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Oncology • Otorhinolaryngology • Pneumonia • Primary Immunodeficiency • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Rheumatology • Solid Tumor