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

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

Exacerbation and cardiopulmonary risk after prompt initiation of single-inhaler budesonide /glycopyrrolate/formoterol fumarate following COPD exacerbations: Insights from MITOS EROS (Japan) study. (PubMed, Respir Investig) - "Following COPD exacerbations, initiating BGF promptly was associated with reduction in subsequent exacerbations. Patients should receive prompt and proactive treatment to reduce COPD morbidity."

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

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=78 ➔ 280

Enrollment change • Platinum resistant • Platinum sensitive • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

LUNG FUNCTION BENEFITS OF BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL FUMARATE TRIPLE THERAPY FOR THE TREATMENT OF INADEQUATELY CONTROLLED ASTHMA: KALOS AND LOGOS STUDY RESULTS (CHEST 2025) - "KALOS and LOGOS, two Phase III, double-blind, double-dummy, randomized studies, compared fixed-dose triple combination budesonide/glycopyrrolate/ formoterol fumarate via pressurized metered dose inhaler (pMDI) using Aerosphere co-suspension delivery technology (BGF) with budesonide/formoterol fumarate via pMDI using Aerosphere co-suspension delivery technology (BFF) or as Symbicort pMDI (BUD/FORM), which use slightly different formoterol fumarate doses (BFF, 9.6 μg; BUD/FORM, 9 μg)... BGF 36 is superior to dual ICS/LABA therapy with BUD/FORM on lung function and severe exacerbations adults and adolescents with asthma inadequately controlled by ICS/LABA. CLINICAL IMPLICATIONS: These findings suggest BGF 36 is a treatment option with meaningful effects in people with asthma inadequately controlled with ICS/LABA, including those without an exacerbation history in the previous year."

Late-breaking abstract • Asthma • Immunology • Respiratory Diseases

REAL-WORLD EFFECTIVENESS OF BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL FUMARATE ON COPD EXACERBATIONS AMONG US MEDICARE PATIENTS: RESULTS FROM THE US ARCTOS STUDY (CHEST 2025) - "Moderate exacerbations were defined as an outpatient COPD visit accompanied by a filled prescription for a course of theophylline, aminophylline, or an oral corticosteroid or oral antibiotic within 7 days of the outpatient visit... Medicare Fee-for-Service patients with a diagnosis of COPD who were treated with BGF demonstrated meaningful reductions in the rate of COPD exacerbations, inclusive of severe exacerbations, in a real-world setting. CLINICAL IMPLICATIONS: Results suggest that BGF is an excellent treatment option to reduce exacerbations in patients who meet GOLD E criteria and can potentially inform clinical guidelines and future research. Funding: The funding for this study was provided by AstraZeneca PLC"

Clinical • Medicare • Real-world • Real-world effectiveness • Real-world evidence • Reimbursement • US reimbursement • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

SARCOID IN A CAVITY: A RARE PRESENTATION OF A COMMON GRANULOMATOUS DISEASE (CHEST 2025) - "Patient has history of exertional dyspnea for 6 years and diagnosed with COPD and use breztri with symptoms improvement and no exacerbations... With our case, we are presenting an extremely rare presentation of pulmonary sarcoidosis."

Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Sarcoidosis • Tobacco Addiction • Vasculitis • TNFA

Triple Therapy Inhaler Improves Lung Function in Poorly Controlled Asthma (MedPageToday) - "Budesonide/glycopyrrolate/formoterol fumarate (BGF, Breztri Aerosphere) reduced the primary endpoint of change from baseline to 24 weeks in morning pre-dose trough forced vital capacity in 1 second (FEV1) compared with a budesonide/formoterol fumarate (Symbicort) metered-dose inhaler by 71 mL in the KALOS trial and 91 in the LOGOS trial (both P<0.001) at the higher glycopyrrolate dose tested (320/36/9.6 μg BID)."

P3 data • Asthma

Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dehydrate in Spain: ORESTES Study. (PubMed, Adv Ther) - P | "These real-world findings suggest that BGF may provide clinical benefit with high treatment persistence in complex, high-risk patients with COPD, even following high-intensity therapy. The observed improvements, despite advanced disease, raise the possibility that earlier initiation of BGF may help optimize outcomes; however, further study is warranted."

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

RCT Abstract - Budesonide/glycopyrronium/formoterol fumarate dihydrate triple therapy for inadequately-controlled asthma: KALOS and LOGOS study results (ERS 2025) - No abstract available

Asthma • Immunology • Respiratory Diseases

Effectiveness and safety of Budesonide/Glycopyrronium/Formoterol (BGF) in severe to very severe airflow obstruction in COPD: sub-group analysis of AIR-FORCE*study (ERS 2025) - "BGF DPI/pMDI significantly improved lung function, symptom relief and exercise endurance in severe to very severe COPD, optimizing treatment outcome *AIR-FORCE study: A n Open label S I ngle arm,Multicentric,P R ospective,Phase IV study to evaluate the Safety and E F fectiveness of Glyc O pyrronium/Fo R moterol fumarate/Budesonide triple therapy (TT) in the management of C OPD pati E nts."

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

Evaluation of patient reported outcomes & satisfaction with Budesonide/Glycopyrronium/Formoterol (BGF) in COPD: AIR-FORCE*study (ERS 2025) - "BGF DPI/pMDI significantly improved PRO, particularly dyspnea & adherence, enhancing patient's quality of life. *AIR-FORCE study: A n Open label S I ngle arm, Multicentric, P R ospective, Phase IV study to evaluate the Safety and E F fectiveness of Glyc O pyrronium/Fo R moterol fumarate/Budesonide triple therapy (TT) in the management of C OPD pati E nts. Table 1: Mean mMRC score at baseline and follow-up visits Visits BGF DPI (Mean ± SD) BGF pMDI (Mean ± SD) p-value (DPI vs pMDI) Baseline 2.98 ± 0.61 3.05 ± 0.72 0.47 Week 4 2.67 ± 0.72 2.81 ± 0.76 0.29 Week 12 2.08 ± 0.58 2.19 ± 0.74 0.15 Week 24 1.53 ± 0.74 1.61 ± 0.75 0.22"

Clinical • Patient reported outcomes • Chronic Obstructive Pulmonary Disease • Immunology • Mood Disorders • Psychiatry • Respiratory Diseases

Real-world outcomes of Budesonide/Glycopyrronium/Formoterol therapy in COPD after 12 months; the RECORD study (ERS 2025) - "At M12 49.3% (n=217) had an improvement in CAT score of ≥2 points (minimal clinically important difference [MCID]); 53.1% (N=209) had MCID (≥4) change in SGRQ. These results suggest that BGF treatment over 12 months is associated with sustained improvements in exacerbation rates, lung function, and quality of life."

Clinical • Real-world • Real-world evidence • Cardiovascular • Chronic Obstructive Pulmonary Disease • Hypertension • Immunology • Respiratory Diseases

Patient reported improvement in dyspnea and physical inactivity with Budesonide/Glycopyrronium/Formoterol (BGF): AIR-FORCE*study (ERS 2025) - "BGF DPI/pMDI significantly reduced dyspnea severity, transitioning patients from severe to moderate/mild symptoms with no disabling dyspnea. * AIR-FORCE study: A n Open label S I ngle arm,Multicentric,P R ospective PhaseIV study to evaluate the Safety and E F fectiveness of Glyc O pyrronium/ Fo R moterol fumarate/ Budesonide triple therapy (TT) in the management of C OPD pati E nts."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease

Clinical and patient-reported outcomes of COPD patients after 12 weeks of treatment with Budesonide/Glycopyrronium/Formoterol: interim analysis of the CHOROS ORION real-life study in Italy (ERS 2025) - "Interim data from CHOROS ORION suggest early symptoms and clinical improvement in COPD pts over 12w of treatment with BGF. Final study results will provide comprehensive evidence over 52 weeks."

Clinical • Patient reported outcomes • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Understanding Perceptions and Place of Triple Therapy for Asthma Management: The ESCALATE Survey (ERS 2025) - "Survey findings indicate that SITT is well-accepted for treatment of uncontrolled asthma with glycopyrronium-formoterol-budesonide being the favored combination. Patient profiles perceived to benefit with early initiation of triple therapy include patients with asthma-COPD overlap, smoking history and recurrent exacerbators."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Effect of Fixed BDP/FF/G Therapy on Cough Efficacy in Moderate-Severe COPD (ERS 2025) - "This pragmatic study shows that in poorly controlled COPD patients, fixed triple BDP/FF/G treatment can significantly reduce LH and improve CE, thereby increasing quality of life and disease control."

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