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

FLUTICASONE FUROATE/UMECLIDINIUM/VILANTEROL VS BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL IN COPD: A MULTINATIONAL PROPENSITY SCORE-MATCHED STUDY (CHEST 2026) - No abstract available

Chronic Obstructive Pulmonary Disease • Immunology • 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 (ERS 2026) - "Both BGF and FUV improved small airway function and clinical symptoms. No significant differences in SAD parameters were observed between the two treatment regimens. These findings suggest comparable overall efficacy; however, larger and longer-term studies are needed to confirm potential differences in small airway effects."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Breztri rPMS: BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate or BGF (320/28.8/10μg)) has been approved in the European Union (EU) as a maintenance treatment for asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA). (AstraZeneca Press Release) - "The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and was based on the positive results from the KALOS and LOGOS Phase III trials."

EMA approval • Asthma • Immunology

Expert analysis: How early optimisation with TRIXEO could improve patient outcomes in COPD (ERS 2026) - "Sponsored by AstraZeneca"

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Healthcare resource utilization (HCRU) in COPD during 52 weeks of treatment with budesonide/glycopyrronium/formoterol: results from the CHOROS ORION real-world study in Italy (ERS 2026) - "These results suggest a resource-use burden reduction during BGF treatment in Italian COPD patients. Study sponsored by AstraZeneca."

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

Moderate-to-severe exacerbation risk among patients with COPD who had one recent exacerbation: a post-hoc analyses of the ETHOS and KRONOS studies (ERS 2026) - P3 | "Findings support the management of exacerbation risk with BGF vs LAMA/LABA or ICS/LABA in patients with moderate-to-severe COPD following a single exacerbation, per GOLD 2026."

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

Patient-reported improvement in dyspnea with novel Single Nebulised Triple Therapy versus Single Inhaler Triple Therapy in elderly vs non-elderly COPD Patients: A subgroup analysis of an Indian phase III study (ERS 2026) - "SNTT improved dyspnea more than single-inhaler pMDI triple therapy, particularly in elderly COPD patients with significant reductions in disabling breathlessness across age groups."

Clinical • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Budesonide/glycopyrronium/formoterol fumarate dihydrate effects on clinical remission in inadequately controlled asthma: post hoc analyses of KALOS and LOGOS studies (ERS 2026) - "Background: The Phase 3 KALOS and LOGOS studies in uncontrolled asthma showed improved lung function and exacerbation rates with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) in an Aerosphere® MDI vs combined budesonide/formoterol fumarate dihydrate (Aerosphere® MDI, BFFA; or Symbicort®, BFFS)... BGF 28.8 triple therapy improved odds of clinical remission over BFF dual therapy in participants with uncontrolled asthma."

Clinical • Retrospective data • Asthma • Immunology • Respiratory Diseases

Budesonide/glycopyrronium/formoterol fumarate dihydrate effects on lung function and asthma exacerbations by persistent airflow limitation status: post hoc analyses of KALOS and LOGOS studies (ERS 2026) - "The KALOS and LOGOS studies in inadequately controlled asthma showed improved LF and exacerbation rates with budesonide/glycopyrronium/formoterol fumarate dihydrate via Aerosphere® MDI (BGF 28.8; 320/28.8/10 µg) vs combined budesonide/formoterol fumarate dihydrate (BFFCombined) via Aerosphere® MDI (BFFA) or Symbicort® (BFFS)... BGF 28.8 showed benefits over BFFCombined with improved LF and reduced severe exacerbations irrespective of PAL status."

Retrospective data • Asthma • Immunology • Respiratory Diseases

Budesonide/glycopyrronium/formoterol fumarate dihydrate effects on time to first clinically important deterioration and number needed to treat for clinically important deterioration rate: tertiary analyses of KALOS and LOGOS studies (ERS 2026) - "Background: KALOS and LOGOS studies in uncontrolled asthma showed improved lung function with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF 28.8; 320/28.8/10 µg) vs combined budesonide/formoterol fumarate dihydrate (Aerosphere® MDI, BFFA; or Symbicort®, BFFS)... BGF 28.8 prolonged time to first CID with a low NNT vs either BFF formulation, highlighting the benefits of BGF as a treatment option in uncontrolled asthma."

Clinical • Asthma • Immunology • Respiratory Diseases

Patient reported outcomes, sleep quality, and physical activity in COPD patients on beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) dry powder inhaler fixed single triple therapy (DPIFSTT): 6-month TriNEXT realworld results (ERS 2026) - "CONCLUSIONS COPD patients who switched to DPIFSTT experienced clinically meaningful improvements in symptoms and QoL, whether switching from DT or TT. SQ remained stable over 6 months."

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

Use of in silico deposition models to highlight the importance of breath holding manoeuvre, coordination and aerosol droplet distribution for pressurized metered dose inhalers (ERS 2026) - "Deposition is strongly affected by particle size and inhalation technique. In the coarser BUD/FF/G formulation, deposition occurs mainly in extra-thoracic and central airways, with pulmonary deposition below 40%. Finer formulations like BDP/FF/G increase distal deposition, improving pulmonary targeting by ~10%."

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

Lung deposition distribution of two triple combination pMDI aerosol drugs (ERS 2026) - "Introduction Currently, Trimbow® (BDP/GLY/FF) and Trixeo Aerosphere® (BDP/GLY/FF) are the only fixed-dose triple combination drugs in pMDI format available in the market. A slightly upward mouthpiece insertion enhanced lung deposition, whereas a downward orientation reduced it compared to horizontal positioning. Conclusion This study provides new insights into the aerodynamic behaviour of triple‑combination pMDIs and highlights both the similarities in whole‑lung deposition and the differences in regional dose distribution between the two formulations."

Respiratory Diseases

Lung function improvement in patients with moderate-to-severe COPD switching to extrafine BDP/FF/G DPI: results from the RESPONSE study (ERS 2026) - P | "Switching to extrafine triple therapy via DPI leads to significant improvements in lung function in real-world COPD patients with a marked effect on severe patients, usually associated with a worse lung function decline. These findings highlight the efficacy of BDP/FF/G in improving lung function despite the severity of obstruction."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Efficacy of budesonide/formoterol/glycopyrronium in Indian patients with uncontrolled asthma: an interim analysis of a prospective, single-center study (ERS 2026) - "No SAEs and no AEs leading to discontinuation were reported. Conclusions In Indian patients with uncontrolled asthma, budesonide/formoterol/glycopyrronium therapy showed significant 12‑week gains in asthma control and lung function, supporting triple therapy as an effective real‑world step‑up option."

Clinical • Asthma • Immunology • Respiratory Diseases

SUSTAINED LUNG FUNCTION BENEFIT OF 12-HOURS WITH BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL FUMARATE THERAPY FOR INADEQUATELY CONTROLLED ASTHMA: KALOS AND LOGOS SUBSTUDY RESULTS (CHEST 2026) - No abstract available

Asthma • Immunology • Respiratory Diseases

BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL FUMARATE EFFECTS ON ASTHMA CONTROL USING THE 7-ITEM ASTHMA CONTROL QUESTIONNAIRE: INSIGHTS FROM THE KALOS AND LOGOS STUDIES (CHEST 2026) - No abstract available

Asthma • Immunology • Respiratory Diseases

Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate Treatment Effects by T2 Biomarkers: KALOS and LOGOS Studies Post-Hoc Analyses (ACAAI 2026) - No abstract available

Biomarker • Late-breaking abstract • Retrospective data

Pharmaceutical assessment of low global warming potential alternatives to HFA-134a in a budesonide, glycopyrrolate, and formoterol fumarate pressurized metered dose inhaler. (PubMed, J Pharm Sci) - "Given that each pMDI is a unique combination of APIs, device, propellant, and excipients, propellant substitution requires product-specific evidence and regulatory approval, and typically takes several years. Targeted analyses, such as those described here, helped to identify the most suitable candidate propellant for successful substitution in the BGF pMDI."

Journal

Particle engineering, aerosol physics, and pulmonary deposition of single-inhaler triple ICS/LABA/LAMA therapies in obstructive airway diseases. (PubMed, Eur J Intern Med) - "Five device platforms are currently approved: two extrafine formulations delivering beclomethasone dipropionate/formoterol/glycopyrronium (the Modulite solution pressurised metered-dose inhaler [pMDI] and the NEXThaler breath-actuated dry powder inhaler [DPI]); the co-suspension pMDI Aerosphere platform (budesonide/glycopyrrolate/formoterol); the standard-particle Ellipta DPI (fluticasone furoate/umeclidinium/vilanterol); and the low-resistance, single-dose capsule-based DPI Breezhaler (mometasone furoate/indacaterol/glycopyrronium)...Rational device selection requires structured assessment of patient inspiratory capacity, disease phenotype, coordination, and adherence. Head-to-head scintigraphy and prospective imaging-outcome studies represent major evidence gaps."

Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Real-World Prospective Observational Study to Describe the Safety Profile and Clinical Outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) In Chinese Patients with Chronic Obstructive Pulmonary Disease (COPD). (PubMed, COPD) - P | "In real-world practice, BGF MDI demonstrated good tolerability consistent with previous RCTs, and associated with a trend toward improvement in patients' symptoms, quality of life, and lung function, regardless of asthma history, exacerbation history, or baseline treatment. NCT04536402 (ClinicalTrials.gov), registered on 28 August 2020."

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

Comparative Real-World Effectiveness of Fixed-Dose Triple Therapy Regimens in COPD: A Retrospective Cohort Study. (PubMed, J Clin Med) - "We compared real-world clinical outcomes among adults with COPD receiving fluticasone furoate/vilanterol/umeclidinium (FF/VI/UMEC) or budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR)... In this large propensity score-matched real-world cohort study, patients receiving BUD/GLY/FOR experienced lower rates of COPD exacerbations and acute respiratory failure than those receiving FF/VI/UMEC. Because of the retrospective observational nature of the analysis, these findings should be considered hypothesis-generating and require confirmation in prospective comparative effectiveness studies."

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

Breztri Aerosphere: Data from P3 THARROS trial (NCT06283966) for COPD post 2027 (AstraZeneca) - H1 & Q2 2026 Results

P3 data • Chronic Obstructive Pulmonary Disease

Trixeo recommended for approval in the EU by CHMP for the maintenance treatment of asthma (AstraZeneca Press Release) - "Recommendation based on KALOS and LOGOS Phase III trials demonstrating statistically significant and clinically meaningful benefits of AstraZeneca’s single-inhaler fixed-dose triple therapy compared with inhaled dual therapy."

CHMP • Asthma • Immunology