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

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."

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=200 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Aug 2025 ➔ Mar 2026 | Trial primary completion date: Aug 2025 ➔ Mar 2026

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

A Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Early Intervention with Glycopyrrolate/Formoterol Fumarate MDI in Patients with Mild and Moderate Chronic Obstructive Pulmonary Disease (ChiCTR) - P=N/A | N=318 | Completed | Sponsor: The First Affilated Hospital of Guangzhou Medical Universtiy; Guangzhou Institute of Respiratory Health | Not yet recruiting ➔ Completed

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

Triple inhaled therapy of formoterol/glycopyrrolate/budesonide reduces the use of oral corticosteroids and antibiotics during COPD exacerbations in real-world conditions. (PubMed, Semergen) - "Triple inhaled therapy in one device reduces the use of oral corticosteroids and antibiotics during COPD period of exacerbations and reduces respiratory hospitalizations without increasing the incidence of pneumonia in comparision with dual inhaled therapy."

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

A-319, a CD3 X CD19 T Cell Engager (TCE), for the Treatment of Severe/Refractory SLE: Early Evidence of Rapid Reset of Disease-Specific Autoimmunity (ACR Convergence 2024) - P1 | "DAS-28 CRP score improved from 5.83 at BL to 1.96 at W2 in Pt 002, while Pt 003 showed improvement of SLE-related vasculitis by W2 (Fig. A-319 is well tolerated in severe/refractory SLE pts without evidence of CRS, ICANS or other safety issues commonly seen in T cell-mediated B cell depletion therapies. A-319 (0.05 + 0.3μg/kg) treatment demonstrated rapid B cell depletion, autoantibody reduction, and organ function improvement as early as W2. Evidence of partial B cell recovery was seen by W2."

Late-breaking abstract • CNS Disorders • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

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=200 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison of Formoterol, Glycopyrrolate, and Beclomethasone Dipropionate Pharmacokinetic Profile after Inhaled Administration as pMDI Using HFA134a or HFA152a Propellant: Preclinical Assessment of Drug Exposure in Sprague-Dawley Rat Model. (PubMed, J Aerosol Med Pulm Drug Deliv) - "Higher interanimal variability was observed for the metabolite beclomethasone 17-monopropionate, likely due to individual differences in the metabolite generation. Considering these data, it was possible to conclude that replacing propellant HFA134a with HFA152a in a newly developed formulation had no significant impact on the plasmatic PK profile of formoterol, glycopyrrolate, and BDP in rats after inhalation administration using inhalation towers."

Journal • PK/PD data • Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in COPD: A Post-hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS). (PubMed, Am J Respir Crit Care Med) - P3 | "In the Phase III, 52-week ETHOS trial (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced rates of moderate/severe exacerbations and all-cause mortality versus dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF)...Measurements and Main BGF 320 reduced the rate of first occurrence (hazard ratio [95% confidence interval]) of cardiovascular and severe cardiopulmonary events versus GFF, including for CVAESI (0.63 [0.48, 0.82]), cardiac AE (0.60 [0.48, 0.76]), and severe cardiopulmonary event (0.80 [0.67, 0.95]). BGF had a benefit on cardiovascular endpoints and severe cardiopulmonary events versus GFF in patients with moderate-to-very severe COPD."

Clinical • Journal • P3 data • Retrospective data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison table: Inhaled drugs for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tobacco Cessation

Effective Treatment of COVID-19 Infection with Repurposed Drugs: Case Reports. (PubMed, Viral Immunol) - "Successful administration of multidrug therapy, such as combinations of hydroxychloroquine and azithromycin, doxycycline and ivermectin, or ivermectin, doxycycline, and azithromycin, has been reported. Multidrug therapy is effective because of the differing mechanisms of action of these drugs, and it may also mitigate the emergence of drug-resistant SARS-CoV-2 strains. The medicines were lopinavir/ritonavir (Kaletra), bamlanivimab (monoclonal antibody), glycopyrrolate-formoterol (Bevespi), ciclesonide (Alvesco), famotidine (Pepcid), and diphenhydramine (Benadryl)."

Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Thrombosis

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=200 | Not yet recruiting | Sponsor: AstraZeneca

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

PT2003: Designed to be Different: A Next Generation Bruton's Tyrosine Kinase Inhibitor (BTKi) in CLL (EHA 2024) - "Supported By BeiGene"

Chronic Lymphocytic Leukemia

Comparing Glycopyrronium/Formoterol Combination Therapy With Monotherapy in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD): A Narrative Review. (PubMed, Cureus) - "Factors influencing treatment choice and future directions in COPD management are also discussed. This review underscores the potential of combination therapy in optimizing COPD treatment outcomes and highlights areas for further research and clinical practice refinement."

Combination therapy • Journal • Monotherapy • Review • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases