Trimbow (beclometasone/formoterol/glycopyrrolate) / Chiesi - LARVOL DELTA

Exacerbation Reduction Over Three Years with Beclometasone/Formoterol/Glycopyrronium in Asthma: Real-World Evidence from the TriMaximize Study (ERS 2026) - "Significant and sustained reduction in exacerbations was observed over a three-year period in patients with moderate to severe asthma treated with BDP/FF/G."

Clinical • HEOR • Real-world • Real-world evidence • Asthma • Immunology • Respiratory Diseases

Sustained Asthma Control Over Three Years with Beclometasone/Formoterol/Glycopyrronium: Results from the TriMaximize Study (ERS 2026) - "Asthma control significantly improved after initiation of BDP/FF/G and then remained stable throughout the 3-year follow-up. This indicates that BDP/FF/G therapy is a valuable option for the long-term treatment of asthma patients."

Asthma • Immunology • Respiratory Diseases

Beclometasone/formoterol/glycopyrronium triple therapy protects COPD patients from mortality and cardiovascular events: insights from a Bayesian analysis (ERS 2026) - "Very strong evidence supported reduced risk of MACE (LogOR -0.41, 95%CI -0.81 – -0.020; BF 45.52) and IHD (LogOR -0.51, 95%CI -0.99 – -0.04; BF 52.63). Detailed information is shown in Figure 1.ConclusionBDP/FF/G shows strong to very strong evidence of reducing all-cause mortality, MACE, and IHD vs. BT, supporting its protective survival and cardiovascular benefits in COPD."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Coronary Artery Disease • Heart Failure • Immunology • Respiratory Diseases

Potential Impact of Extra-fine BDP/FF/GB Triple Therapy on Dynamic Hyperinflation Assessed by Metronome Paced Tachypnea in COPD: A Longitudinal Pilot Study (ERS 2026) - "MPT could represent a sensitive, physiology-based tool for assessing hyperinflation and distal airway dysfunction. Extra-fine triple therapy might confer a greater de-inflating effect, possibly through enhanced peripheral airway targeting. Larger controlled studies would be required to confirm these preliminary observations."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Effects of switching to extrafine medium strength triple therapy versus escalation of high strength dual-therapy regimen in patients with asthma or asthma-COPD overlap previously treated with medium-strength dual therapy (ERS 2026) - "For patients whose asthma remains uncontrolled on medium strength (MS) ICS/LABA, GINA guidelines recommend stepping up to high strength (HS) ICS/LABA or using MS ICS/LABA/LAMA such as beclometasone/formoterol/glycopyrronium (BDP/FF/G)...1). Patients received significantly less ICS inhalers and lower mean daily ICS exposure with no significant difference of mean daily OCS exposure.Extrafine MS BDP/FF/G is an effective alternative to HS ICS/LABA for with asthma or asthma-COPD overlap patients escalating from MS ICS/LABA, delivering comparable control with lower CS dose."

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

Treatment adherence improvement in COPD patients after initiation of Extrafine Beclometasone Dipropionate, Formoterol, and Glycopyrronium in DPI formulation: results from the RESPONSE study. (ERS 2026) - " RESPONSE is an observational, prospective study involving four European countries (Czechia, Bulgaria, Slovenia, Hungary), investigating effectiveness of Trimbow 88/5/9 inhalation powder treatment over 6 months, switching from LABA-LAMA or ICS-LABA in moderate and severe COPD patients... In moderate and severe COPD patients, switching from LABA/LAMA or ICS/LABA to SITT with BDP/FF/G in DPI formulation is associated with a significant improvement of adherence to inhalers. These results confirm the potential role of SITT in improving the treatment adherence in COPD patients."

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

Coarse Particle Mass Deposition from Trimbow MDI and Trelegy DPI: In Vitro Comparison and Implications for Oropharyngeal and Oral Side Effects (ERS 2026) - "These in vitro data provide guidance to clinicians that pairing the AeroChamber Plus Flow-Vu* spacer with a Trimbow MDI minimizes the CPM, the fraction associated with oropharyngeal deposition. By retaining the CPM in the chamber, the spacer significantly reduces oropharyngeal deposition (by ca. 96%), thereby lowering local oral medical and dental health risks."

Adverse events • Preclinical • Asthma • Immunology • Respiratory Diseases • Xerostomia

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

Assessment of lung function parameters in patients with COPD on triple therapy with Trimbow extra-fine pMDI (TefpMDI) for 16 weeks – a multicenter observational study. (ERS 2026) - "The group of patients with potential better response to therapy was identified. Although some of the results could be biased due to the open label design the data showed improvement regarding efficacy and tolerability of triple therapy in real life."

Clinical • Observational data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Hypertension • Immunology • Respiratory Diseases

Real-world effectiveness of extrafine single inhaler triple therapy (efSITT) via NEXThaler device on health status and sleep quality in Greek COPD Patients: Results from the CONFIDENCE study (ERS 2026) - "Background: The efficacy of efSITT with beclometasone/formoterol/glycopyrronium (BDP/FF/G) in COPD has been demonstrated in randomized controlled trials and supported by real-world data, mainly for the pMDI formulation... These real-world data suggest significant improvements in health status and sleep quality in COPD patients, after switching to BDP/FF/G NEXThaler."

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

TRIMAXIMIZE: Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting (clinicaltrials.gov) - P=N/A | N=233 | Completed | Sponsor: Chiesi Italia | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 ?g]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 ?g]) (clinicaltrials.gov) - P4 | N=644 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Not yet recruiting ➔ Recruiting

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

Airway deposition of two fixed-dose triple combination pMDI drugs at different inhalation flow rates and insertion angles. (PubMed, Eur J Pharm Sci) - "The objective of this study was to establish a robust experimental and computational framework for characterizing pressurized metered-dose inhaler (pMDI) plumes and quantifying regional deposition fractions of two triple-combination aerosol drugs, Trimbow® (BDP/GLY/FF) and Trixeo Aerosphere® (BUD/GLY/FF). A slightly upward mouthpiece insertion enhanced lung deposition, whereas a downward orientation reduced it compared to horizontal positioning. These findings underscore the importance of inhalation technique and device orientation in optimizing therapeutic efficacy of pMDI-delivered triple-combination drugs."

Journal

Toward Next-Generation Propellants: Assessing Lung Deposition of Beclometasone Dipropionate, Formoterol, and Glycopyrrolate Formulated with HFA-152a Using Functional Respiratory Imaging. (PubMed, J Aerosol Med Pulm Drug Deliv) - "Reformulation of the BDP/FF/GB pMDI with the low-GWP propellant HFA-152a preserved total and regional lung deposition characteristics relative to the current HFA-134a formulation. These findings support the maintenance of deposition performance while enabling a substantial reduction in environmental impact, reinforcing the potential of HFA-152a as a next-generation propellant for carbon minimal pMDI therapies."

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

Real-World Effectiveness and Safety of Extrafine Triple Therapy in COPD Patients with Comorbid and Cardiovascular Conditions. (PubMed, Int J Chron Obstruct Pulmon Dis) - "This analysis provides real-world evidence supporting extrafine BDP/FF/GB SITT as an effective and safe option for COPD patients with comorbidities, including CV history or risk. These findings help address an evidence gap in vulnerable populations and support timely initiation of SITT in high-risk patients in clinical practice."

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

TRICHECO: Efficacy and Safety of CHF 5993 100/6/12.5 ?g HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting 2-agonists (clinicaltrials.gov) - P3 | N=554 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Not yet recruiting ➔ Recruiting

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

BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg]) (clinicaltrials.gov) - P4 | N=644 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P4 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Trimbow: Newly added patents in Orange Book (Orange Book) - Expiry on Dec 23, 2030 and Dec 23, 2034

Patent • Chronic Obstructive Pulmonary Disease

CLI-05993AB1-08: BETRI-Prospective: Asthma control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 g]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 g]) (clinicaltrialsregister.eu) - P4 | N=606 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P4 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

CLI-05993AB1-08: BETRI-Prospective: Asthma control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 g]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 g]) (clinicaltrialsregister.eu) - P4 | N=371 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P4 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TRECONY: Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma (clinicaltrials.gov) - P2 | N=780 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | N=250 ➔ 780

Enrollment change • Trial initiation date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TRICHECO: Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists (clinicaltrials.gov) - P3 | N=554 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

RETRIBUTE: Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients (clinicaltrials.gov) - P=N/A | N=396 | Recruiting | Sponsor: Chiesi Farmaceutica Ltda. | Not yet recruiting ➔ Recruiting

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

VENTURI (VENTilation Using Respiratory Imaging) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: University of Alabama at Birmingham | Not yet recruiting ➔ Recruiting

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

TRECONY: Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | N=165 ➔ 250

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