budesonide/formoterol (PT009) / AstraZeneca - LARVOL DELTA

Budesonide/glycopyrronium/formoterol fumarate dihydrate triple therapy for inadequately-controlled asthma: KALOS and LOGOS study results (BTS WM 2025) - "KALOS and LOGOS, two Phase 3, double-blind, double-dummy randomised studies, compared fixed-dose triple combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) with budesonide/formoterol fumarate dihydrate via metered-dose inhaler (MDI; BFF) and via pressurised MDI ([Symbicort ® ] BUD/FORM)...BGF 320/28.8/10 μg is superior to dual ICS/LABA in adults and adolescents with asthma inadequately-controlled by ICS/LABA. View this table: View inline View popup Download powerpoint Abstract P297 Table 1 Summary of primary and secondary efficacy endpoint results (European regulatory approach)"

Asthma • Immunology • Respiratory Diseases

Frequent productive cough in COPD relates to exacerbation risk and treatment benefit from budesonide/glycopyrrolate/formoterol fumarate: a post hoc analysis of KRONOS. (PubMed, Respir Med) - P3 | "Among participants without an exacerbation history in the prior 12 months, FPC identified those at higher exacerbation risk. Further, BGF was associated with lower COPD exacerbation rates versus GFF, including numerically lower among those with moderate COPD and regardless of FPC status."

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

ATHLOS: A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Sep 2025 ➔ Jan 2026

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

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

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (clinicaltrials.gov) - P3 | N=644 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

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

A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS) (clinicaltrials.gov) - P3 | N=373 | 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=2178 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) (clinicaltrials.gov) - P3 | N=2212 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (clinicaltrials.gov) - P3 | N=645 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • 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

A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS) (clinicaltrials.gov) - P3 | N=374 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS) (clinicaltrials.gov) - P3 | N=340 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Sep 2024 ➔ Jan 2025 | Trial primary completion date: Sep 2024 ➔ Jan 2025

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

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (clinicaltrials.gov) - P3 | N=630 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2024 ➔ Mar 2025

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

Effect of Triple Inhaled Therapy With Budesonide/Glycopyrrolate/Formoterol Fumarate on Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post-hoc Analysis of ETHOS (ATS 2024) - P3 | "In the Phase III, 52-week ETHOS study (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced the risk of moderate/severe COPD exacerbations versus dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF)... BGF 320 was associated with a reduction in risk across novel cardiopulmonary endpoints, as well as traditional endpoints, versus GFF in patients with moderate-to-very severe COPD and a history of recent exacerbations. These findings highlight the benefit of BGF in reducing the risk of a range of cardiopulmonary outcomes beyond traditional COPD endpoints."

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

AstraZeneca announces initiation of THARROS – a Phase III clinical trial investigating the potential of BREZTRI to improve cardiopulmonary outcomes in people with COPD (AstraZeneca Press Release) - "AstraZeneca today announced the initiation of a Phase III trial to investigate the potential effect of triple-combination inhaled therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate, or BGF) on severe cardiopulmonary outcomes, including death, in people with chronic obstructive pulmonary disease (COPD) who also have elevated cardiopulmonary risk, irrespective of their exacerbation history....Also, the first participants have been dosed in ATHLOS, a Phase III trial investigating AstraZeneca’s triple therapy BGF vs. ICS/LABA budesonide/formoterol fumarate (BFF) or placebo on cardiopulmonary parameters including hyperinflation and exercise endurance time..."

Trial status • Chronic Obstructive Pulmonary Disease

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (clinicaltrials.gov) - P3 | N=630 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jul 2024 ➔ Dec 2024

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

ATHLOS: A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | Trial primary completion date: May 2025 ➔ Aug 2025

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

ATHLOS: A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: AstraZeneca

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

PT009. AES Poster Spotlight: Waste & Disaster Recovery (ASM Microbe 2023) - No abstract available

Budesonide/Glycopyrrolate/Formoterol Fumarate Effects on Exacerbations of Chronic Obstructive Pulmonary Disease Based on Airflow Limitation: A Post-hoc Analysis of the KRONOS Study (ATS 2023) - P3 | "Eligible patients were randomized (2:2:1:1) to treatment with BGF 320/18/9.6 µg, GFF 18/9.6 µg, and budesonide/formoterol fumarate (BFF) 320/9.6 µg via a metered-dose inhaler and open-label budesonide/formoterol fumarate 400/12 μg (BUD/FORM) via a dry-powder inhaler... Triple ICS/LAMA/LABA therapy with BGF reduced exacerbation rates versus dual LAMA/LABA therapy, in a population not requiring an exacerbation history, even in those with less severe airflow limitation. These findings provide clinicians with additional evidence for consideration when selecting COPD treatment for patients."

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

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) (clinicaltrials.gov) - P3 | N=2200 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jan 2024 ➔ Mar 2025 | Trial primary completion date: Jan 2024 ➔ Mar 2025

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

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (clinicaltrials.gov) - P3 | N=2200 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

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

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (clinicaltrials.gov) - P3 | N=630 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Oct 2023 ➔ Jul 2024 | Trial primary completion date: Oct 2023 ➔ Jul 2024

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

A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS) (clinicaltrials.gov) - P3 | N=340 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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