Bevespi Aerosphere (formoterol/glycopyrrolate) / AstraZeneca - LARVOL DELTA

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

Utilization Patterns of Nebulized Glycopyrronium in Patients Hospitalized for Acute Exacerbations of Obstructive Airway Disease (AEOAD)-Indian Expert Perspectives. (PubMed, Adv Respir Med) - " Experts reported that AEOAD management commonly involved initial stabilization with SABA/SAMA followed by transition to triple therapy with nebulized glycopyrronium, formoterol, and budesonide...Experts also noted potential improvements in hospital stay and readmissions; however, these observations were based on clinical experience rather than controlled data. Indian pulmonologists agreed that early initiation of nebulized glycopyrronium (with formoterol and budesonide) in hospitalized AEOAD may improve symptom control, lower exacerbation burden, reduce reliance on short-acting bronchodilators and corticosteroids, and shorten hospital stays."

Journal • Bronchiectasis • Cardiovascular • Pulmonary Disease • Respiratory Diseases

Comparative Effectiveness and Safety of Fluticasone-Umeclidinium-Vilanterol and Beclomethasone-Glycopyrronium-Formoterol Single-Inhaler Triple Therapies for COPD: Real-World Observational Study [Letter]. (PubMed, Int J Chron Obstruct Pulmon Dis) - No abstract available

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

Breztri Aerosphere for asthma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

CHRONICLES: Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF] (clinicaltrials.gov) - P=N/A | N=152 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

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

Comparative Effectiveness and Safety of Fluticasone-Umeclidinium-Vilanterol and Beclomethasone-Glycopyrronium-Formoterol Single-Inhaler Triple Therapies for COPD: Real-World Observational Study. (PubMed, Int J Chron Obstruct Pulmon Dis) - "In a real-world clinical practice setting of COPD treatment, initiating triple therapy with FUV was associated with a lower incidence of moderate and severe exacerbations than with BEGF. On the other hand, the incidence of a severe pneumonia requiring hospitalisation was higher with FUV among GOLD Group E subjects or those whose blood eosinophil count is not elevated."

Clinical • HEOR • Journal • Observational data • Real-world evidence • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler in patients with tuberculosis-associated chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. (PubMed, J Thorac Dis) - P4 | "Chinese Clinical Trial Registry, ChiCTR2500103088. Registered on May 23, 2025."

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

An Indirect Comparison of Budesonide/ Glycopyrrolate/ Formoterol Fumarate Versus Fluticasone/ Umeclidinium/ Vilanterol in Adults With Uncontrolled Asthma From a US Perspective: A Systematic Review and Network Meta Analysis (ATS 2026) - No abstract available

Retrospective data • Review • Asthma • Immunology • Respiratory Diseases

Comparative Effectiveness and Safety of LAMA-LABA Inhalers in Chronic Obstructive Pulmonary Disease. (PubMed, JAMA Intern Med) - "This cohort study found that umeclidinium-vilanterol was associated with improved clinical outcomes compared with glycopyrrolate-formoterol and tiotropium-olodaterol. Patients, prescribers, and health systems may consider once-daily umeclidinium-vilanterol dry powder inhalers over alternatives among new users of LAMA-LABA therapy."

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

OSCIVARI: Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: University Hospital, Lille | N=35 ➔ 4 | Recruiting ➔ Terminated; Following Brexit and the unavailability of the experimental drug (PT003) in France, the study was terminated prematurely.

Enrollment change • Trial termination • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Environmentally sustainable UV spectrophotometric-chemometric approach for simultaneous determination of budesonide, glycopyrrolate, and formoterol. (PubMed, BMC Chem) - "It was successfully applied to both multi-component (Breztri Aerosphere®) and single-component inhalers (Budecort®, Seebri Breezhaler®, and Metrohaler®), confirming selectivity, accuracy, and robustness across pharmaceutical matrices. Its simplicity, affordability, and eco-friendly profile make it readily transferable to both industrial and regulatory laboratories. This validated protocol establishes a cost-effective and environmentally responsible alternative to chromatography, offering a practical solution for routine Chronic obstructive pulmonary disease drugs monitoring and pharmaceutical quality assurance."

Journal • 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

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

CHRONICLES: Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF] (clinicaltrials.gov) - P=N/A | N=149 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • HEOR • 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

Comparative effectiveness and safety of fluticasone-based versus beclometasone-based single-inhaler triple therapies in patients with chronic obstructive pulmonary disease: a population-based cohort study. (PubMed, Int J Clin Pharm) - "This cohort study conducted in an Asian COPD population suggests that fluticasone/umeclidinium/vilanterol may be a preferred initial treatment option over beclometasone/glycopyrrolate/formoterol. While among patients who are able to maintain their therapies for ≥ 90 days, both treatments may demonstrate more comparable effectiveness and safety profiles."

HEOR • Journal • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • 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

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

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

Safety and Efficacy of Budesonide/ Glycopyrrolate/Formoterol Fumarate (BGF) compared to Glycopyrrolate/ Formoterol Fumarate (GFF) for the Treatment of COPD: A Systematic Review & Meta Analysis. (PubMed, J Am Pharm Assoc (2003)) - "BGF MDI significantly improves lung function compared to GFF MDI in moderate-to-severe COPD and has a comparable safety profile. Further large-scale studies are needed to confirm long-term safety."

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

AQbD-Based Development and Validation of HPTLC Method for Simultaneous Determination of Glycopyrronium, Formoterol Fumarate and Budesonide in Rotacaps. (PubMed, J Chromatogr Sci) - "The method was found specific and precise for the estimation of drugs. The developed method was applied for the assay of rotacaps and results were found in good agreement with the label claim."

Journal

Glycopyrrolate/formoterol fumarate MDI in mild-to-moderate chronic obstructive pulmonary disease (PIONEER): a protocol for a randomised, double-blind, placebo-controlled trial. (PubMed, BMJ Open Respir Res) - P=N/A | "The study protocol has been approved by the Ethics Committee of The First Affiliated Hospital, Guangzhou Medical University (2022-23、2024-K-005), and all collaborating centres have obtained approval from their respective ethics committees. Results will be presented at national and international meetings and submitted for publication in peer-reviewed journals within the field."

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

A 12-week randomized, open-label, parallel-group, multicenter clinical study of glycopyrrolate formoterol inhalation aerosol in the treatment of post-tuberculosis chronic obstructive pulmonary disease (ChiCTR) - P4 | N=146 | Not yet recruiting | Sponsor: Guangzhou Chest Hospital; Guangzhou Chest Hospital

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

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

Triple Therapy in Focus: The Importance of a Proactive Approach (ATS 2025) - "Sponsored by AstraZeneca Description Join Sanjay Sethi, MD to explore recently published data on lung deposition of triple therapies and gain real world insights on the use of BREZTRI AEROSPHERE® (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol and the importance of a proactive risk reduction mindset for managing your patients."