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

Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY) (clinicaltrials.gov) - P=N/A | N=362 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Active, not recruiting ➔ Completed

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

Achieving asthma remission with extrafine beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) pMDI in adults with moderate-to-severe asthma: a post-hoc analysis of the TRIMARAN and TRIGGER Studies (BTS WM 2025) - "Conclusions A greater proportion of patients achieved clinical remission while on treatment with BDP/FF/GB triple therapy than with BDP/FF. The difference was particularly noted in patients whose asthma was previously uncontrolled on high-dose ICS/LABA treatment who were stepped-up to high-dose BDP/FF/GB."

Clinical • Retrospective data • Asthma • Immunology • Respiratory Diseases

Extra-fine particle deposition of triple inhaler therapies using the next generator impactor (BTS WM 2025) - "View this table: View inline View popup Download powerpoint Abstract P268 Table 1 1 within the BDP/FF/GB pMDI formulation; 2 within the BUD/FF/GB pMDI formulation; 3 within the FLU/VIL/UMEC DPI formulation Conclusions The extra-fine formulation of BDP/FF/GB pMDI delivers a substantially higher proportion of extra-fine particles compared to both BUD/FF/GB pMDI and FLU/VIL/UMEC DPI. These findings suggest greater potential to target small airways, which in turn may be clinically relevant in optimising disease control in asthma and COPD."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Exacerbation and rescue medication reduction with extrafine formulation single-inhaler triple therapy in adult asthma patients: outcomes from the TriMaximize UK study (BTS WM 2025) - P | "Background Randomised controlled trials have shown clinical benefits of extrafine formulation single-inhaler triple therapy (SITT) consisting of beclometasone/formoterol/glycopyrronium (BDP/FF/G) in asthma patients uncontrolled on a combination of an inhaled corticosteroid and long-acting beta-agonist with at least one exacerbation in the prior year, 1 yet there is limited evidence in a real-world setting...Lancet . 2019; 394 (10210):1737–49."

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

Time course of exacerbation reduction with extrafine beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) pMDI in adults with moderate to severe asthma: a post-hoc analysis of the TRIMARAN and TRIGGER studies (BTS WM 2025) - "Download figure Open in new tab Download powerpoint Abstract P298 Figure 1 Conclusions A clinically relevant reduction in the number of severe asthma exacerbations can be seen as early as 4 months following step-up therapy to BDP/FF/GB. This reduction was progressive and sustained over the remainder of the 12-month treatment."

Clinical • Retrospective data • Asthma • Immunology • Respiratory Diseases

Treatment with extrafine formulation single-inhaler triple therapy improves health-related quality of life and asthma control – results from the TriMaximize UK study (BTS WM 2025) - P | "Background The efficacy of an extrafine formulation single-inhaler triple therapy (SITT) consisting of beclometasone/formoterol/glycopyrronium (BDP/FF/G) in patients with asthma has been demonstrated in randomised controlled trials (RCTs), 1 yet there is limited evidence in real-world settings...Lancet . 2019; 394 (10210):1737–49."

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

Real-World Efficacy of BDP/FF/G Fixed Triple Inhalation Powder (NEXThaler) Therapy in the Treatment of Moderate to Severe COPD patients (RESPONSE Study). (PubMed, Respir Med) - "The RESPONSE study is the first to evaluate the real-world effectiveness of the BDP/FF/G 88/5/9 μg DPI in patients with moderate to severe COPD. At the time of publication, this DPI formulation represents the only available extrafine particle-size fixed triple combination therapy for COPD. We demonstrated that BDP/FF/G DPI led to improvements in symptoms, quality of life, lung function, and even in adherence after patients were switched from dual therapy (LABA/LAMA or ICS/LABA)."

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

Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS). (clinicaltrials.gov) - P3 | N=836 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Trial primary completion date: Nov 2024 ➔ Feb 2025

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

TRIAP: Assessing the adherence of COPD patients to extra-fine Single Inhaler-Triple Therapy (efSITT) using BDP/FF/GB in Austria– observational, multicentre, open-label, non interventional study (NIS) (OGP-OGTC 2025) - "The results of this study could provide valuable insights for the future design of COPD-treatment strategies and contribute to improving patients' QoL."

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

Chiesi Announces FDA Acceptance of New Drug Application for its Triple Combination Inhaler for the Maintenance Treatment of Asthma (GlobeNewswire) - "The NDA is supported in part by data from the TRIMARAN and TRIGGER studies, which are double-blind, parallel group, randomized, active-controlled Phase 3 trials."

FDA filing • Asthma • Immunology

Impact of dry powder Beclometasone/Formoterol/Glycopyrronium Extrafine Single Inhaler Triple Therapy (efSITT) in patients with Chronic Obstructive Pulmonary Disease (COPD): TriNEXT Study (ERS 2025) - "Statistically and clinically relevant improvement of respiratory symptoms and HRQoL was observed at M3. Most patients of the study stepped up from dual therapy to DPI efSITT."

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

Improvement in Quality of Life in Asthma Patients switched to fixed triple combination with Beclometasone/Formoterol/Glycopyrronium: 12-Month Results of TriMaximize Study (ERS 2025) - "A significant improvement in the quality of life of asthma patients was observed over a 12-month treatment period with the fixed combination of BDP/FF/G. This therapy offers a promising option for the long-term management of moderate-to-severe asthma."

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases

Long-Term Asthma Control with Beclometasone/Formoterol/Glycopyrronium: 12-Month Results of TriMaximize Study (ERS 2025) - "Significant improvement in asthma control in patients with moderate to severe asthma after 12 months of treatment with BDP/FF/G suggests that this triple therapy is a beneficial long-term treatment option for asthma patients."

Asthma • Immunology • Respiratory Diseases

Ensifentrine synergistically relaxes hyperreactive human bronchi from COPD donors in combination with ICS, LABA, and LAMA (ERS 2025) - "Relaxant responses were measured in epithelium intact (EP+) and denuded (EP-) bronchi pre-contracted with carbachol (EC70) and stimulated by electrical field stimulation (EFS; 3-25 Hz)...Synergy was observed at low ensifentrine concentrations (EC30) when combined with GB (+17.50±3.08%), BDP/FF (+18.65±6.26%), FF/GB (+19.28±3.77%), BDP/FF/GB (+19.39±3.06%); additive effect resulted with FF...This suggests ensifentrine is a valuable COPD adjunct, supported by Phase III ENHANCE trial data. Funding: Verona Pharma plc."

Combination therapy • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Improved Treatment Adherence in Asthma Patients with Beclometasone/Formoterol/Glycopyrronium: 12-Month Results of TriMaximize Study (ERS 2025) - "Significant improvement in treatment adherence was observed in patients with moderate to severe asthma over a 12-month period of fixed triple BDP/FF/G therapy."

Adherence • Clinical • Asthma • Immunology • Respiratory Diseases

Drug delivery from a Metered Dose Inhaler (MDI) / Spacer delivering triple therapy and self reported observations from COPD patients following the introduction of a Spacer (ERS 2025) - " Cascade Impactor testing was performed using Trimbow* beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BD/FF/GB 100/6/12.5 mcg/actuation) pMDI, delivered 0s after actuation, simulating perfect but unlikely coordination... These results suggest that the Spacer tested can enable effective pMDI drug delivery, providing consistent delivery of the intended dose (even with poor coordination) and maximize fine particle delivery. The COPD patients surveyed provided positive feedback relating to confidence in medication delivery and some also reported less emergency visits / side effects."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

SiASMARTer: Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Chiesi Pharma AB, Nordic | Not yet recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ Sep 2027 | Initiation date: May 2025 ➔ Sep 2025 | Trial primary completion date: May 2027 ➔ Sep 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

STRENGTH: Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (clinicaltrials.gov) - P=N/A | N=281 | Active, not recruiting | Sponsor: Chiesi Bulgaria | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Feb 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Enrollment closed • Real-world evidence • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TRICOLON: Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Franciscus Gasthuis | Trial completion date: Sep 2024 ➔ Dec 2026 | Trial primary completion date: Sep 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • 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=200 | Active, not recruiting | Sponsor: Chiesi Italia | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ Jun 2026 | Trial primary completion date: Oct 2025 ➔ Jun 2026

Enrollment closed • Real-world evidence • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY) (clinicaltrials.gov) - P=N/A | N=359 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Robotic tracheobronchoplasty from the perspective of anesthetic assistance: a case report (Euroanaesthesia 2025) - "History of severe, refractory asthma, complicated by tracheomalacia, using Beclometasone + Formoterol + Glycopyrronium and Salmeterol + Fluticasone.3 Salbutamol puffs were administered just before anesthetic induction, which was performed with Fentanyl, Propofol and Rocuronium...Maintenance was achieved with continuous infusion of Propofol, Remifentanil and Rocuronium. Adjuvants included Ketamine, Methadone, Magnesium Sulfate, Lidocaine and Dexmedetomidine. Tranexamic acid was administered to reduce risk of bleeding.During the surgical procedure, selective ventilation and periods of apnea were required for tracheal suturing...She was discharged 7 days later without complications. Robotic-assisted tracheobronchoplasty has been first described in the last 10 years1, and anesthesia for this procedure presents additional challenges with the use of the robotic system, the need for immobility and intermittent ventilatory maneuvers. This case demonstrates a successful approach..."

Case report • Clinical • Anesthesia • Asthma • Immunology • Respiratory Diseases

Synergistic Bronchorelaxant Effects of Ensifentrine in Combination With Inhaled Therapies in a Human Ex Vivo Model of COPD (ATS 2025) - "Relaxation responses were measured in bronchi with both intact and denuded epithelium that had been pre-contracted with carbachol at EC70...Synergistic effects were observed at low concentrations (EC30) when ensifentrine was combined with GB (+17.50±3.08%), BDP/FF (+18.65±6.26%), FF/GB (+19.28±3.77%), BDP/FF/GB (+19.39±3.06%)...These findings suggest that ensifentrine could be a valuable adjunct in COPD management, reinforcing clinical evidence from recent Phase III ENHANCE trials [1]. This study was funded by Verona Pharma plc."

Combination therapy • Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases

Economic Evaluation of Single-Inhaler Extrafine Beclometasone Dipropionate/formoterol fumarate/glycopyrronium (Trimbow®) in Adult Patients with Uncontrolled Asthma in Mexico (ISPOR 2025) - "The annual per-patient cost for BDP/FF/G was $3,881.34, compared to Beclometasone/Formoterol ($4,373.36), Budesonide/Formoterol ($6,098.29), Salmeterol/Fluticasone ($14,014.57), and Fluticasone/Vilanterol ($14,096.49). The extrafine SITT with BDP/FF/G is a dominant therapeutic option for adults with uncontrolled asthma in Mexico, delivering superior asthma control, significantly reducing exacerbations, and lowering annual per-patient costs compared to therapies currently used by IMSS."

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases

A Budget Impact Analysis of Single-Inhaler Extrafine Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Adult Patients with Uncontrolled Asthma in Mexico (ISPOR 2025) - "Extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G, Trimbow®) has demonstrated superior efficacy by reducing exacerbations and lowering annual per-patient costs versus therapies prescribed at the IMSS... Results indicate that increasing BDP/FF/G prescription at the IMSS will lead to significant clinical and economic benefits."

Clinical • HEOR • Asthma • Immunology • Respiratory Diseases