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

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

Economic Evaluation of Single-Inhaler Extrafine Beclometasone Dipropionate/formoterol fumarate/glycopyrronium (Trimbow®) in Adult Patients with Uncontrolled Asthma in Mexico (ISPOR 2025) - "OBJECTIVES: Achieving optimal asthma control remains a global challenge, despite the availability of effective treatments for most adult patients. 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

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

STRENGTH: Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Chiesi Bulgaria | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • 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=300 | Not yet recruiting | Sponsor: Chiesi Bulgaria

New trial • Real-world evidence • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TRITON: A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (clinicaltrials.gov) - P3 | N=3433 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • 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=837 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting

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

MiSTIC: Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA (clinicaltrials.gov) - P4 | N=320 | Terminated | Sponsor: Chiesi Farmaceutici S.p.A. | Active, not recruiting ➔ Terminated; The study was prematurely stopped due to extensive challenges in patient recruitment. The Sponsor issued a notification of early study termination to all investigational sites and all external stakeholders.

Combination therapy • Trial termination • Asthma • 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 | Active, not recruiting | Sponsor: Chiesi Hungary Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ May 2025

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

STRENGTH: Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting (clinicaltrials.gov) - P=N/A | N=800 | Recruiting | Sponsor: Chiesi Hungary Ltd.

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

Real-life utilization of fixed triple therapy in COPD: The Trilife study. Beclomethasone/formoterol/glycopyrronium triple fixed-dose therapy in extra-fine particles (PubMed, Rev Mal Respir) - "Three quarters of the fixed triple combination prescriptions by French pulmonologists comply with the indication and dosage specified in the summary of product characteristics."

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

Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR® (clinicaltrials.gov) - P1 | N=69 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Completed

Trial completion • 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=790 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial primary completion date: Aug 2024 ➔ Jul 2025

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

Impact of extrafine formulation single-inhaler triple therapy on asthma control and treatment adherence after six months of treatment in patients with asthma-TriMaximize study (ERS 2024) - "Clinical trials have demonstrated significant therapeutic benefits of extrafine formulation single-inhaler triple therapy (efSITT) consisting of beclometasone/formoterol/glycopyrronium in the treatment of patients with asthma... Switching from dual as well as free triple combinations significantly improves asthma control and adherence after six months of efSITT."

Adherence • Clinical • Asthma • Immunology • Respiratory Diseases

Single inhaler extra fine triple therapy versus open triple therapy in COPD: TRIPOLI observational study (ERS 2024) - "The primary endpointwas the variation in the moderate and severe exacerbations over one year with fixed-doseextra fine triple therapy of beclomethasone, formoterol, and glycopyrronium in a single inhaler(Trimbow"

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

Impact Of The 2022 Bronchodilator Responsiveness Criteria On Study Eligibility and Treatment Response To Inhaled Triple Therapy (BDP/FF/GB) In Moderate-To-Severe Asthma: A Post-Hoc Analysis Of TRIMARAN & TRIGGER. (ERS 2024) - "The change in BDR criteria proposed in 2022 would have significantly restricted the enrolment in the TRIMARAN & TRIGGER trials, resulting in deselection of subjects who would particularly benefit from add-on LAMA to ICS/LABA."

Retrospective data • Asthma • Immunology • Respiratory Diseases

The Real-World Efficacy of Fixed Triple Inhalation Therapy in the Treatment of Moderate COPD Patients (RATIONALE Study). (PubMed, Int J Chron Obstruct Pulmon Dis) - "RATIONALE was a non-interventional, prospective, 52 week study, assessing the effectiveness of beclometasone/formoterol/glycopyrronium-bromide (BDP/FF/G), in symptomatic COPD patients, with moderate airflow obstruction...Although limitations of observational studies are present, we observed that early introduction of fixed triple combination results in a marked improvement in adherence to treatment, symptom scores, exacerbation frequency and quality of life. The optimal choice of treatment is crucial for reaching the highest possible adherence."

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