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

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

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 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

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: Oct 2025 ➔ Dec 2026 | Initiation date: Sep 2024 ➔ May 2025 | Trial primary completion date: Oct 2025 ➔ Oct 2026

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

Adherence and Persistence with Single-Inhaler Triple Therapy Among Patients with COPD Using Commercial and Medicare Advantage US Health Plan Claims Data. (PubMed, Adv Ther) - "In this study, patients initiating FF/UMEC/VI had significantly greater adherence and persistence to treatment than patients initiating BUD/GLY/FOR."

Adherence • HEOR • Journal • Medicare • Reimbursement • US reimbursement • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

CHOROS: Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting (clinicaltrials.gov) - P=N/A | N=2000 | Not yet recruiting | Sponsor: AstraZeneca

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

AbbVie’s Skyrizi rockets to top of TV drug ad spenders’ list with single largest monthly total this year (Fierce Pharma) - "AbbVie is reaching for the Skyrizi as it spent a staggering $51.5 million on TV drug ads for its immunology blockbuster in October...That’s according to the latest figures by real-time ad trackers iSpot.TV, which sees the Big Pharma dig deep into its wallet as it handed over nearly $19 million more for its Skyrizi ads in October...In second place is fierce rival Dupixent, the immunology megablockbuster from Sanofi and Regeneron, with the pair spending a healthy $35.2 million in October...AbbVie pops back into third place with its second immunology blockbuster in Rinvoq...However, spending jumped massively from $23.6 million in September to $35.1 million in October...In fourth position is J&J’s ulcerative colitis, psoriatic arthritis and plaque psoriasis drug Tremfya...In the mid-table is AstraZeneca’s respiratory disease therapy Breztri Aerosphere...Lundbeck and Otsuka’s neurology med Rexulti....fell two spots month-over-month into sixth place."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Schizophrenia • Ulcerative Colitis

Budget Impact Analysis of Single Inhaler Triple Therapy (SITT) of Budesonide / Glycopyrronium / Formoterol Fumarate for Moderate to Very Severe Patients With COPD in Argentina (ISPOR-EU 2024) - "Single Inhaler Triple Therapy (SITT: ICS/LAMA/LABA) offers cost-savings to a healthcare budget when replacing multiple inhaler triple therapies (MITTs) in Argentina for patients with moderate to very severe COPD."

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

Real-world effectiveness of budesonide/glycopyrrolate/formoterol in Chinese patients with chronic obstructive pulmonary disease (APSR 2024) - P | " In this multi-centre, prospective, observational, single-arm study (NCT04536402), Chinese COPD patients prescribed with BGF MDI were followed for 12 weeks... Real-world results confirmed BGF improved the health status and lung function over 12 weeks."

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

Economic Impact of the Introduction of Combined Triple Therapy Budesonide/Glycopyrronium/Formoterol in the Continuous Treatment of Chronic Obstructive Pulmonary Disease in Algeria (ISPOR-EU 2024) - "COPD imposes a heavy economic burden. Combined triple therapy could reduce this burden by decreasing exacerbations and improving adherence."

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

Effectiveness of triple therapy to refractory COPD patients and patients' compliance: A multicenter study from Bangladesh (APSR 2024) - "The study demonstrated significant improvements in symptom control, disease progression, and reduction of exacerbations with triple-therapy. Patient satisfaction was observed with improved tolerability and compliance, aligning with global data."

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

Systemic exposure bioequivalence of budesonide/glycopyrronium/formoterol fumarate dihydrate with the potential next generation propellant hydrofluoroolefin-1234ze versus hydrofluoroalkane-134a in healthy adults (BTS WM 2024) - "These data provide evidence that the near-zero GWP HFO-1234ze propellant is a viable replacement for HFA-134a. View this table: View inline View popup Abstract P188 Table 1 Comparison of budesonide, glycopyrronium and formoterol pharmacokinetic parameters for the HFO-1234ze test formulation relative to the HFA-134a reference formulation"

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

Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study. (PubMed, Am J Med) - "In this real-world comparative effectiveness study of patients with COPD initiating BGF or MITT, BGF was associated with lower all-cause mortality and severe cardiopulmonary event risk versus MITT after accounting for between-group differences in baseline sociodemographic and clinical characteristics, supporting the benefits of BGF over MITT and the need to consider proactive use of SITTs in COPD management."

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

Promptly escalating to budesonide/glycopyrronium/formoterol from dual therapy reduces exacerbations and cardiopulmonary events in patients with COPD (MITOS EROS + Cardiopulmonary study) (BTS WM 2024) - "Conclusion Promptly escalating to BGF from dual therapy after an exacerbation was associated with 23% and 31% fewer subsequent AECOPD and 19% and 13% fewer cardiopulmonary events compared to delayed and very delayed groups. Proactive disease management with BGF may be warranted to prevent future AECOPD and cardiopulmonary events among patients with COPD."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Myocardial Infarction • Respiratory Diseases

Prompt initiation of budesonide/glycopyrronium/formoterol reduces exacerbations and cardiopulmonary events in patients with COPD (MITOS EROS + Cardiopulmonary study) (BTS WM 2024) - "Conclusion Promptly initiating BGF following an exacerbation event was associated with 24% and 32% fewer subsequent AECOPD and 12.3% and 9.3% fewer severe cardiopulmonary events compared to delayed and very delayed groups. Proactive disease management with BGF may be warranted to prevent future AECOPD and cardiopulmonary events among patients with COPD."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Myocardial Infarction • Respiratory Diseases

AstraZeneca Pharma gains on plan to launch COPD drug (Business Standard) - "AstraZeneca Pharma India rose 1.84% to Rs 6,515.50 after the durg maker said that it will launch Breztri Aerosphere in January 2025 in India....Breztri Aerosphere is indicated for maintenance treatment to relieve symptoms and prevent exacerbations in adult patients with chronic obstructive pulmonary disease (COPD)....The pharmaceutical firms net profit declined 26.62% to Rs 38.43 crore in Q2 FY25 as compared with Rs 52.37 crore posted in Q2 FY24. Revenue from operations jumped 31.16% YoY to Rs 408 crore in the September 2024 quarter."

Launch non-US • Chronic Obstructive Pulmonary Disease

ORESTES: Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain. (clinicaltrials.gov) - P=N/A | N=700 | Recruiting | Sponsor: AstraZeneca | N=500 ➔ 700

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

Lung exposure bioequivalence with budesonide/glycopyrronium/formoterol fumarate dihydrate with the next generation propellant hydrofluoroolefin-1234ze versus hydrofluoroalkane-134a in healthy adults: a charcoal block study (BTS WM 2024) - "These data provide clinical evidence that the near-zero GWP HFO-1234ze propellant is a viable replacement for HFA-134a. View this table: View inline View popup Abstract P187 Table 1 Comparison of budesonide, glycopyrronium and formoterol pharmacokinetic parameters for the HFO-1234ze test formulation relative to the HFA-134a reference formulation"

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

Breztri Aerosphere: Data from P3 THARROS trial (NCT06283966) for COPD post 2025 (AstraZeneca) - Q3 2024 Results

P3 data • Chronic Obstructive Pulmonary Disease

AstraZeneca Gets CDSCO Panel Nod To Study Budesonide, Glycopyrronium, Formoterol Fumarate (Medical Dialogues) - 'The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III Clinical study of Budesonide, Glycopyrronium, and Formoterol Fumarate. This came after the firm presented Phase III clinical study protocol No.: D5989C00001: CSP Version 2.0 dated 28 January 2024. Addendum IND-1, Version 1.0, 10 Jan 2024. This is a randomized, double-blind, parallel-group, multi-center, Phase III study to assess the efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhalers relative to Glycopyrronium, and Formoterol Fumarate MDI on Cardiopulmonary outcomes in Chronic Obstructive Pulmonary Disease."

Clinical protocol • Chronic Obstructive Pulmonary Disease

Characteristics of Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol or Other Triple Therapies in Japan: A Real-World Healthcare Claims Database Study (MITOS-AURA). (PubMed, Adv Ther) - "Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease."

Claims database • Journal • Real-world • Real-world evidence • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

COMPARING PATIENT ADHERENCE AND PERSISTENCE TO SINGLE-INHALER TRIPLE THERAPY VS MULTIPLE-INHALER TRIPLE THERAPY: A NARRATIVE REVIEW OF REAL-WORLD OBSERVATIONAL STUDIES (CHEST 2024) - "In the US study, patients were included if they initiated SITT with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or MITT... Differences in reimbursement timelines, practice patterns, and data completeness within the included studies introduces a large amount of heterogeneity between studies. Nonetheless, despite these regional and methodological differences, consistently better adherence and persistence with SITT versus MITT was observed at 12 months post-initiation of the study period in these studies. CLINICAL IMPLICATIONS: These data support the GOLD 2024 recommendations1 and suggest a consistent benefit in adherence and persistence with SITT compared with MITT for patients with COPD, irrespective of regional differences."

Adherence • Clinical • Observational data • Real-world • Real-world evidence • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

REDUCED RISK OF CARDIOPULMONARY EVENTS FOR COPD PATIENTS INITIATING BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL VS MULTIPLE INHALER TRIPLE THERAPY IN THE US: THE SKOPOS-MAZI STUDY (CHEST 2024) - "Compared with patients treated with MITT, BGF was associated with a lower risk of severe cardiopulmonary events. This study provides real-world evidence for the reduction of such events with BGF and supports optimization of patients with COPD using BGF instead of MITT. CLINICAL IMPLICATIONS: A multidisciplinary understanding of cardiopulmonary risk is required."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Heart Failure • Immunology • Ischemic stroke • Myocardial Infarction • Respiratory Diseases