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

EROS+CP-Japan: EXACERBATIONS AND REAL-WORLD OUTOMES AMONG PATIENTS WITH COPD INITIATING BREZTRI (EROS+CP Japan Study) (clinicaltrials.gov) - P=N/A | N=3402 | Completed | Sponsor: AstraZeneca

New trial • 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 | Not yet recruiting | Sponsor: AstraZeneca

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

Evaluation of patient reported outcomes & satisfaction with Budesonide/Glycopyrronium/Formoterol (BGF) in COPD: AIR-FORCE*study (ERS 2025) - No abstract available

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

Patient reported improvement in dyspnea and physical inactivity with Budesonide/Glycopyrronium/Formoterol (BGF): AIR-FORCE*study (ERS 2025) - No abstract available

Clinical • Pulmonary Disease

Prompt initiation of single-inhaler budesonide/glycopyrrolate/formoterol fumarate (BGF) following a COPD exacerbation reduces exacerbations and cardiopulmonary risk in patients with COPD: insights from the MITOS EROS + CP Study in the United States. (PubMed, Curr Med Res Opin) - "Similar results were observed for patients escalating from dual therapy and those with asthma. Prompt initiation of BGF following a COPD exacerbation, including among patients previously managed with dual therapy, was associated with lower annualized rates of cardiopulmonary and exacerbation events."

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

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) - No abstract available

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

Economic Analysis of New Single-Inhaler Triple Therapies in Patients with COPD in the UK. (PubMed, Int J Chron Obstruct Pulmon Dis) - "At a willingness-to-pay threshold of £20,000 per QALY, the probability of FF/UMEC/VI being cost-effective was 99.9%, 100%, and 99.3% versus BUD320/GLY/FOR, BUD160/GLY/FOR, and BDP/FOR/GLY, respectively. Based on this analysis, FF/UMEC/VI is a dominant (improved outcomes with cost savings) treatment option compared with other SITTs for the treatment of patients with COPD in the UK."

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

Real-world outcomes of Budesonide/Glycopyrronium/Formoterol therapy in COPD after 12 months; the RECORD study (ERS 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Chronic Obstructive Pulmonary Disease • 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) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Persistence and outcomes after 12 months of patients with COPD initiating formoterol/glycopyrronium/budesonide in Spain. ORESTES study (ERS 2025) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • 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 | Not yet recruiting | Sponsor: AstraZeneca

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

Breztri Aerosphere: Data from P3 ATHLOS trial (NCT06067828) for COPD in H1 2026 (AstraZeneca) - H1 & Q2 2025 Results: Data from P3 THARROS trial (NCT06283966) for COPD post 2026

P3 data • Chronic Obstructive Pulmonary Disease • Immunology

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

Safety of budesonide/glycopyrronium/formoterol fumarate dihydrate delivered by HFO-1234ze versus HFA-134a in chronic obstructive pulmonary disease: a phase 3, multi-site, randomised, double-blind, parallel-group, active-comparator study. (PubMed, EClinicalMedicine) - "These findings support the potential for HFO-1234ze to replace HFA-134a in pMDIs containing BGF, which could be evaluated further in a real-world setting. The study was supported by AstraZeneca."

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

Effect of Fixed BDP/FF/G Therapy on Cough Efficacy in Moderate-Severe COPD (ERS 2025) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Cough • 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) - No abstract available

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

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential (AstraZeneca Press Release) - "AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP)....The CHMP positive opinion is based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the current propellant."

CHMP • Chronic Obstructive Pulmonary Disease

In Silico Lung Deposition Profiles of Three Single-Inhaler Triple Therapies in Patients with COPD Using Functional Respiratory Imaging. (PubMed, Int J Chron Obstruct Pulmon Dis) - "The first part evaluated budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) pressurized metered-dose inhaler (pMDI), beclomethasone dipropionate/glycopyrronium/formoterol fumarate dihydrate (BDP/G/F) pMDI, and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) dry powder inhaler (DPI) at 30 L/min...These findings provide quantitative insights into relative lung deposition distribution profiles and efficiency of delivery for 3 inhaler options. Further research is needed to understand if these deposition patterns could translate into real-world clinical effectiveness differences."

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

A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a New Propellant (HFO) in Participants 40 to 80 Years of Age With COPD (clinicaltrials.gov) - P3 | N=297 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

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

CHOROS ORION: Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol) (clinicaltrials.gov) - P=N/A | N=250 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

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

Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study. (PubMed, Respir Investig) - P | "Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma."

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

INDOS-B: Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P4 | N=150 | Not yet recruiting | Sponsor: AstraZeneca | Trial completion date: Dec 2026 ➔ Jul 2027 | Initiation date: May 2025 ➔ Jul 2025

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

A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults (clinicaltrials.gov) - P1 | N=105 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

COnCORD: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD (clinicaltrials.gov) - P=N/A | N=10 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=250 ➔ 10

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

A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed