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

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

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

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

RESPONSE: NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients (clinicaltrials.gov) - P=N/A | N=1336 | Completed | Sponsor: Chiesi Hungary Ltd. | Recruiting ➔ Completed | N=1000 ➔ 1336

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

Extrafine formulation of beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler in the treatment of asthma: a review. (PubMed, Ther Adv Respir Dis) - "One such formulation is the extrafine combination of beclomethasone dipropionate (BDP), fluticasone furoate (FF), and glycopyrronium bromide (GB), which is delivered via a single pressurized metered-dose inhaler (pMDI). The cost-effectiveness analysis of the BDP/FF/GB SITT suggests favorable outcomes compared to traditional ICS/LABA and ICS/LABA plus tiotropium combinations. Additional data will be forthcoming from the ongoing real-life TRIMAXIMIZE observational study."

Journal • Review • Asthma • 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. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Feb 2025 | Trial primary completion date: Jul 2025 ➔ Nov 2024

Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • 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 | Not yet recruiting | Sponsor: Chiesi Pharma AB, Nordic

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

Innovative Drug Development Approach to Address the Transition to Low Global Warming Potential Propellant Using Hydrofluoroalkane-152a, for Triple Combination Pressurized Metered-Dose Inhaler Products Targeting Small Airways. (PubMed, AAPS PharmSciTech) - "Moreover, proof of the hypothesis that products containing the current propellant and those using a LGWP propellant can achieve equivalent performance is reported, by showing comparability of a triple combination pMDI (Trimbow®) formulated using the LGWP HFA-152a propellant compared with HFA-134a...(Rony et al. in Pulm Pharmacol Ther 85, 2024)."

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

RESPONSE: NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients (clinicaltrials.gov) - P=N/A | N=1000 | Recruiting | Sponsor: Chiesi Hungary Ltd. | Active, not recruiting ➔ Recruiting

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

Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR) (clinicaltrials.gov) - P3 | N=1252 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial primary completion date: Nov 2027 ➔ Aug 2028

Trial primary completion date • 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. (AAAAI-WAO 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

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 (AAAAI-WAO 2025) - "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

Single inhaler with beclometasone, formoterol, and glycopyrronium versus triple therapies in adults with uncontrolled asthma: a systematic review and meta-analysis. (PubMed, Sci Rep) - "The objective of this study was to determine the comparative efficacy of extra-fine single-inhaler medium-dose (MD) or high-dose (HD) of beclometasone/formoterol/glycopyrronium bromide (BDP/FOR/GLY) compared to other triple therapies in patients whose asthma remains uncontrolled with MD or HD inhaled corticosteroids and long-acting β2-agonists...Among single-inhaler triple therapies, MD BDP/FOR/GLY significantly reduced the risk of severe exacerbations (RR [95% CrI] compared to MD fluticasone/umeclidinium/vilanterol: 0.65 [0.49, 0.89]), while HD BDP/FOR/GLY demonstrated an improved trend in reducing severe and moderate-to-severe exacerbations versus HD indacaterol acetate/glycopyrronium bromide/mometasone, fluticasone/umeclidinium/vilanterol, and salmeterol/fluticasone + tiotropium. HD BDP/FOR/GLY and HD BDP/FOR + tiotropium did not differ significantly. Compared to relevant single-inhaler triple therapies, MD and HD BDP/FOR/GLY are associated with a significant benefit..."

Clinical • Journal • Retrospective data • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases