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

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) (clinicaltrials.gov) - P3 | N=2274 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (clinicaltrials.gov) - P3 | N=2187 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TRIAENA: Real-world, 52-week Prospective Study to Capture the Reasons for Switch to Triple Combination Therapy, Assess the Clinical and Patient Reported Outcomes in Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Trixeo Aerosphere™ in Routine Care Settings in Greece (clinicaltrials.gov) - P=N/A | N=218 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

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

Characteristics of Patients Receiving Budesonide/Glycopyrronium/Formoterol for Chronic Obstructive Pulmonary Disease in Spain: The AURA Study. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Single-inhaler triple therapy with budesonide/glycopyrronium/formoterol fumarate (BGF; Trixeo Aerosphere®) was approved in the European Union in December 2020 for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by dual therapy, and has been available in Spain since February 2022...Patients initiating single-inhaled BGF triple therapy escalated from monotherapy (2.3%) or dual therapy (62.7%), switched from other triple therapies (31.3%), or were treatment-naïve (3.7%). Single-inhaler BGF triple therapy was initiated mostly as an escalation from dual maintenance therapy, with many switching from triple therapy, in patients with a high burden of disease, as demonstrated by their frequent exacerbation profile, advanced COPD severity (moderate to very severe obstruction) and the high frequency of several comorbidities, including cardiovascular diseases."

Journal • Observational data • Retrospective data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Dyslipidemia • Hypertension • Immunology • Metabolic Disorders • Mood Disorders • Psychiatry • Pulmonary Disease • Respiratory Diseases

MINERVA: MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA (clinicaltrials.gov) - P=N/A | N=4 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • 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=28 | Not yet recruiting | Sponsor: Thammasat University

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

Cost-Effectiveness and Budget Impact Analysis of Triple Therapy with Budesonide, Glycopyrronium, and Formoterol Fumarate Dihydrate Versus Dual Therapies in Managing Moderate-to-Severe COPD (ISPOR 2025) - "Despite certain data limitations, BUD/GLY/FOR demonstrated clinical effectiveness, safety, and acceptable cost-effectiveness. It is recommended as a maintenance therapy for moderate to severe COPD patients transitioning to triple therapy within Kazakhstan's outpatient healthcare system. This approach is anticipated to improve patient outcomes and quality of life while maintaining economic feasibility."

Cost effectiveness • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Prompt Initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) After an Exacerbation Is Associated With Reduced Exacerbation and Cardiopulmonary Risk in Patients With COPD: The MITOS EROS+CP (US) Study (ATS 2025) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Reduced COPD Exacerbation Risk With Prompt Initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) After a COPD Exacerbation Among Patients With COPD and Concurrent Asthma: The MITOS EROS+CP (US) Study (ATS 2025) - No abstract available

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

Real-World Effectiveness of Budesonide/Glycopyrrolate/Formoterol Fumarate on COPD Exacerbation-Related Healthcare Utilization and Costs: Results From the US Arctos Study (ATS 2025) - No abstract available

Clinical • HEOR • Late-breaking abstract • Real-world • Real-world effectiveness • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

In Silico Lung Deposition of Budesonide/Glycopyrrolate/Formoterol Fumarate in Patients With COPD and Concomitant Asthma (ATS 2025) - No abstract available

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

Systemic Exposure of Budesonide/Glycopyrrolate/Formoterol Fumarate With Hydrofluoroolefin-1234ze Versus Hydrofluoroalkane-134a Propellants Administered Via Metered-Dose Inhaler With a Spacer in Healthy Adults (ATS 2025) - No abstract available

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

The Relationship Between the Timing of Budesonide/Glycopyrronium/Formoterol Fumarate (BFG) Initiation Following an Exacerbation and the Occurrence of Subsequent Exacerbations in a Real-World Setting: MITOS EROS (Japan) Study (ATS 2025) - No abstract available

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

The Betri Study: Preliminary Information on Characteristics of Patients With Asthma or Asthma and Concomitant 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) (ATS 2025) - No abstract available

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

Cardiopulmonary Risk Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate Triple Therapy: A Number Needed to Treat Post Hoc Analysis of the ETHOS Trial (ATS 2025) - No abstract available

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

Characteristics of Patients with Asthma or Asthma-Chronic Obstructive Pulmonary Disease (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) (AAAAI-WAO 2025) - "Conclusions Contrary to guidelines and trial evidence, msBDP/FF/G was preferentially prescribed over hsICS/LABA to patients with worse disease who were older and active smokers. Confounder-matched/adjusted comparisons of efficacy between msBDP/FF/G and hsICS/LABA are warranted."

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

Breztri Aerosphere: Data from P3 ATHLOS trial (NCT06067828) for COPD in H2 2025 (AstraZeneca) - Q4 & FY2024 Results: Data from P3 THARROS trial (NCT06283966) for COPD post 2026

P3 data • Chronic Obstructive Pulmonary Disease

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 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database. (PubMed, Front Pharmacol) - "Notably, this study found an association between the above PTs and drugs, and the causal relationship needs to be verified by further longitudinal studies. Our study provides a preliminary exploration of the safety of clinical use of BUD/GLY/FOR and FF/UMEC/VI, and clinicians should be alert to potential adverse effects."

Adverse events • Journal • Asthma • Candidiasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Comparative effectiveness and safety of single inhaler triple therapies for chronic obstructive pulmonary disease: new user cohort study. (PubMed, BMJ) - "Budesonide-glycopyrrolate-formoterol was not associated with improved clinical outcomes compared with fluticasone-umeclidinium-vilanterol. Given the added climate impact of metered dose inhalers, health systems seeking to decrease use of these products may consider steps to promote further prescribing of fluticasone-umeclidinium-vilanterol compared with budesonide-glycopyrrolate-formoterol in people with COPD."

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

Comparative Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol and Budesonide/Glycopyrrolate/Formoterol Fumarate among US Patients with Chronic Obstructive Pulmonary Disease. (PubMed, Adv Ther) - "In this real-world comparative effectiveness study, FF/UMEC/VI was associated with significantly lower rate and risk of COPD exacerbations than BUD/GLY/FORM."

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

SKOPOS:MAZI: A Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Chronic Obstructive Pulmonary Disease (COPD) Patients Who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US) (clinicaltrials.gov) - P=N/A | N=22369 | Completed | Sponsor: AstraZeneca

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

Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS. (PubMed, Int J Chron Obstruct Pulmon Dis) - P3 | "BGF was estimated to have benefits on lung function, exacerbations, and health-related quality of life versus dual therapies in patients with COPD and phenotypic features of asthma. ClinicalTrials.gov NCT02497001 and NCT02465567."

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

ORESTES: Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain. (clinicaltrials.gov) - P=N/A | N=553 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

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

EROS+CP (US): EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study) (clinicaltrials.gov) - P=N/A | N=13000 | Completed | Sponsor: AstraZeneca

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