Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca - LARVOL DELTA

Early intervention in patients with mild to moderate chronic obstructive pulmonary disease (ChiCTR) - P4 | N=1070 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangzhou Medical University

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

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study (clinicaltrials.gov) - P4 | N=22 | Completed | Sponsor: Thammasat University | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Response to: Letter to the Editor Regarding 'Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dehydrate in Spain: ORESTES Study'. (PubMed, Adv Ther) - No abstract available

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

Letter to the Editor Regarding "Comparative Effectiveness of FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up From Dual Therapy". (PubMed, Adv Ther) - No abstract available

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

Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate After Dual and Triple Therapy in Spain: A Sub-Study of the ORESTES Study. (PubMed, Pulm Ther) - P | "In this real-world Spanish cohort of patients with COPD not adequately controlled with DT or TT, reductions in exacerbations, rescue medication use, and HCRU were observed after BGF initiation, supporting the potential value of earlier introduction of BGF in patients with persistent symptoms and/or frequent exacerbations despite high-intensity therapy."

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

iCHOROS: Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo (clinicaltrials.gov) - P=N/A | N=1400 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

Effectiveness and Safety of Glycopyrronium-Formoterol-Budesonide Triple Therapy in Chronic Obstructive Pulmonary Disease (AIR-FORCE): An Open-Label Multi-Centric Phase 4 Study. (PubMed, Adv Respir Med) - "GFB was well tolerated, with mild-to-moderate adverse events in 14.67%, and outcomes were comparable between MDI and DPI. Our findings support GFB as safe and effective treatment in real-world COPD management."

Journal • P4 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Effect of budesonide/glycopyrronium/formoterol fumarate dihydrate on cardiopulmonary outcomes in COPD: rationale and design of the THARROS trial. (PubMed, ERJ Open Res) - "Approximately 5000 patients will be randomised to achieve 632 participants with ≥1 primary severe adjudicated cardiopulmonary event. This first-of-its-kind cardiopulmonary outcomes trial will determine the effect of BGF on a novel composite end-point comprising severe cardiopulmonary events in a broad COPD population with elevated cardiopulmonary risk not currently using ICS-containing maintenance therapy."

Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Myocardial Infarction • 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

COnCORD: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD (clinicaltrials.gov) - P=N/A | N=10 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

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

ORATOS: A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P4 | N=56 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ATHLOS: A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (clinicaltrials.gov) - P3 | N=171 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

TETRIS - Prospective study to observe clinical outcomes of triple therapy in COPD patients: up to 12 months interim analysis. (PubMed, Respir Med) - P | "Overall, SITT dosed OD, specifically FF/UMEC/VI is associated with a significant reduction in hospitalisations due to exacerbations and improvement in symptoms at the 6-month and 1-year follow-up visits."

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

Cost-effectiveness modeling of mortality risk reduction comparing two fixed-dose combination triple therapies in moderate-to-very severe chronic obstructive pulmonary disease. (PubMed, J Comp Eff Res) - "Due to a reduced mortality rate, more patients remained on BGF treatment than on FF/UMEC/VI, which induced higher treatment-related costs; however, the latter was offset by decreased end-of-life costs, as BGF avoided more deaths. BGF may improve health outcomes and reduce healthcare costs compared with FF/UMEC/VI in patients with moderate-to-very severe COPD in a UK setting."

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

VARI-OSCIL: Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: University Hospital, Lille | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

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

Exposure to Budesonide, Glycopyrronium, and Formoterol With a Next-Generation Propellant Does Not Exceed Exposure With Hydrofluoroalkane-134a Propellant When Administered Via Pressurized Metered-Dose Inhaler With a Spacer. (PubMed, Clin Ther) - "These findings provide evidence that may help to support the future use of HFO-1234ze propellant in BGF pMDIs."

Journal

Budesonide/glycopyrronium/formoterol fumarate dihydrate triple therapy for inadequately-controlled asthma: KALOS and LOGOS study results (BTS WM 2025) - "KALOS and LOGOS, two Phase 3, double-blind, double-dummy randomised studies, compared fixed-dose triple combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) with budesonide/formoterol fumarate dihydrate via metered-dose inhaler (MDI; BFF) and via pressurised MDI ([Symbicort ® ] BUD/FORM)...BGF 320/28.8/10 μg is superior to dual ICS/LABA in adults and adolescents with asthma inadequately-controlled by ICS/LABA. View this table: View inline View popup Download powerpoint Abstract P297 Table 1 Summary of primary and secondary efficacy endpoint results (European regulatory approach)"

Asthma • Immunology • Respiratory Diseases

Real-life outcomes of patients with COPD initiating budesonide/glycopyrronium/formoterol after a previous dual therapy in Spain. ORESTES study (BTS WM 2025) - "Treatment persistence with BGF at 12 months was 91.5%. View this table: View inline View popup Download powerpoint Abstract M11 Table 1 Baseline characteristics and main outcomes of patients initiating BGF after dual therapy Conclusion In the ORESTES study conducted in Spain, patients with COPD who escalated from dual therapy to BGF showed high treatment persistence at 12 months and experienced clinically meaningful improvements, including reductions in exacerbations and decreased use of additional treatments."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

The BETRI study: preliminary information on characteristics of patients with asthma or asthma-COPD overlap treated with medium-strength inhaled corticosteroid/long-acting beta-agonists (ICS/LABA) and switching to high-strength ICS/LABA or medium-strength beclomethasone/formoterol/glycopyrronium (BDP/FF/G) (BTS WM 2025) - "Exacerbations, SABA, steroid burden and cardiovascular co-morbidities were also important drivers. Confounder-matched/adjusted comparisons of efficacy between msBDP/FF/G and hsICS/LABA are warranted."

Clinical • Allergic Rhinitis • Asthma • Cardiovascular • Chronic Kidney Disease • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Heart Failure • Hypertension • Immunology • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • Respiratory Diseases

Real-Life Efficacy of Single-Inhaler Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate in Persistent COPD Users: A Retrospective Database Study. (PubMed, Biomedicines) - " Our real-life evaluation highlighted that B/F/G treatment may be effective, even in the long term, in reducing exacerbations, OC and SABA consumption and in improving lung function in COPD patients with high persistence/adherence to B/F/G compared to other non-persistent inhaled therapies previously taken. Optimizing treatment adherence should be one important goal of COPD patients' management to maximize the therapy benefits."

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

iCHOROS: Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo (clinicaltrials.gov) - P=N/A | N=1400 | Not yet recruiting | Sponsor: AstraZeneca | Initiation date: Sep 2025 ➔ Dec 2025

Real-world evidence • Trial initiation date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Impact of Budesonide-Glycopyrronium Formoterol Initiation on Healthcare Resource Utilization and Carbon Emissions in Patients With COPD in Spain: Insights From the ORESTES Study (ISPOR-EU 2025) - "Reductions in hospitalizations, costs, and carbon emissions were observed after BGF initiation, suggesting that better disease control can drive both better clinical outcomes and greater environmental sustainability."

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

Impact of Nonclinically Driven Inhaler Initiation or Switch on Carbon (CO2) Emissions and Healthcare Costs for COPD Patients Using Single-Inhaler Triple Therapy (SITT) (ISPOR-EU 2025) - "Furthermore, continuing these policies after the introduction of pMDIs with NGPs completely negated CO2e savings, resulting in a 12 to 13-fold increase in total CO2e emissions noting TRIXEO/BREZTRI with the next-generation propellant already being approved by UK Medicines and Healthcare Products Regulatory Agency as of 2025. Non-clinically driven SITT initiation or switching policies to DPIs may initially appear to offer CO2e emission savings, but these benefits are largely offset by increased emissions from poorer clinical control and healthcare resource utilization. Non-clinically driven SITT initiation or switching policies to DPIs may initially appear to offer CO2e emission savings, but these benefits are largely offset by increased emissions from poorer clinical control and healthcare resource utilization. Policies and guidelines encouraging a preferred DPI initiation or switch for environmental reasons should be updated to account for pMDIs with NGP, which have..."

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

Budget Impact Analysis of Single-Inhaler Triple Therapy (SITT) of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate for Moderate to Very Severe Patients With COPD in Argentina (ISPOR-EU 2025) - "Single Inhaler Triple Therapy (SITT: ICS/LAMA/LABA) offers cost-savings to a healthcare budget when replacing multiple inhaler triple therapies (MITTs) in Argentina for patients with moderate to very severe COPD"

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

Frequent productive cough in COPD relates to exacerbation risk and treatment benefit from budesonide/glycopyrrolate/formoterol fumarate: a post hoc analysis of KRONOS. (PubMed, Respir Med) - P3 | "Among participants without an exacerbation history in the prior 12 months, FPC identified those at higher exacerbation risk. Further, BGF was associated with lower COPD exacerbation rates versus GFF, including numerically lower among those with moderate COPD and regardless of FPC status."

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