Glycopyrronium 7.2micrograms/dose / Formoterol 5micrograms/dose inhaler CFC free

IntroductionChronic obstructive pulmonary disease (COPD) is a significant global health issue characterized by persistent airflow limitation and inflammation. Triple fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS), long-acting β2-agonists (LABA), and long-acting muscarinic antagonists (LAMA) show promise by potentially enhancing bronchodilation and anti-inflammatory effects. Although randomized controlled trials (RCTs) provide efficacy data, they may not fully represent real-world clinical practice, highlighting the value of real-world evidence (RWE).MethodsThis study conducted a systematic review and meta-analysis of prospective observational multicenter studies to evaluate the real-world effectiveness of a triple extrafine FDC containing beclomethasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G) in moderate-to-severe COPD patients. Databases MEDLINE and SCOPUS were searched for relevant studies reporting on the COPD Assessment Test (CAT) score and forced expiratory volume in one second (FEV1).ResultsThe meta-analysis included seven studies with 5952 patients, indicating high methodological quality with Newcastle-Ottawa Scale scores ≥7. Results showed significant improvement in CAT scores (-5.82 95% CI -7.61 - -4.03; P 1 (127 mL 95% CI 42-212; P ConclusionThe triple extrafine BDP/FF/G FDC effectively improves health status and lung function in real-world COPD patients, supporting its use as a viable therapeutic strategy. Further research should explore long-term outcomes and investigate specific patient subgroups to optimize individualized treatment approaches.

Abstract licence: CC BY-NC

AIM: This study aims to systematically evaluate which single-inhaler triple therapy (inhaled corticosteroids [ICS], long-acting β2-agonists [LABA], and long-acting muscarinic antagonists [LAMA]) is safer and more effective for treating chronic obstructive pulmonary disease (COPD). METHODS: A comprehensive search was performed in PubMed, Embase, Ovid, Cochrane library and Google Scholar from database establishment to November 2025. Searches were limited to English articles. The RCTs that compared single-inhaler triple therapy (ICS/LABA/LAMA) with triple therapy (ICS/LABA+LAMA) or dual therapy (ICS/LABA or LABA/LAMA) for COPD were included. Minimum duration ≥ 12 weeks and minimum participant numbers ≥ 300 patients. Outcomes included forced expiratory volume in 1 s (FEV1), moderate and severe exacerbations, St George’s Respiratory Questionnaire (SGRQ) total score and SGRQ responders, transition dyspnea index (TDI) focal score and safety. RESULTS: 12 RCTs (n = 28930 patients) were included in this network meta-analysis. Fluticasone furoate/vilanterol/umeclidinium (FF/VIL/UMEC) was statistically significantly more effective at increasing trough FEV1 (based on change from baseline) than dual therapies (ICS/LABA or LABA/LAMA), free triple therapy (ICS/LABA+LAMA), budesonide/formoterol fumarate/glycopyrronium bromide (BUD/FOR/GLY) and beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FOR/GLY). In addition, FF/VIL/UMEC, BUD/FOR/GLY, and free triple therapy (ICS/LABA+LAMA) showed significant improvement in the total SGRQ score to dual therapies (ICS/LABA or LABA/LAMA). FF/VIL/UMEC and free triple therapy (ICS/LABA+LAMA) showed borderline significant improvement in the total SGRQ score to BDP/FOR/GLY. CONCLUSION: The four available single-inhaler triple therapies and free triple therapy appear to have similar effectiveness and safety. Given the absence of direct comparison studies differences cannot be found with a sufficient level of certainty. Further analysis is needed, as additional evidence becomes available.

Abstract licence: CC BY-NC-ND

BackgroundIn patients with asthma uncontrolled by a medium or high-strength (MS/HS) inhaled corticosteroid (ICS) plus long-acting β2-agonist (LABA), according to Global Initiative for Asthma (GINA) guidelines, a maintenance therapy option is the addition of a long-acting muscarinic antagonist (LAMA) via single-inhaler triple therapy (SITT). Evidence has previously been published on the cost-effectiveness of a SITT extra fine formulation of beclomethasone, formoterol and glycopyrronium bromide (BDP/FOR/GLY) vs. dual ICS/LABA combination, using data from two 52-week clinical trials (TRIMARAN and TRIGGER). However, there is limited evidence on the comparative cost-effectiveness of SITTs. The current analysis evaluated the cost-effectiveness of BDP/FOR/GLY versus other SITTs, in the UK setting.MethodsMarkov cohort state-transition model was developed to investigate the cost-effectiveness of BDP/FOR/GLY Medium Strength (MS) vs. fluticasone, umeclidinium, and vilanterol (FF/UMEC/VI) MS and, BDP/FOR/GLY High Strength vs. FF/UMEC/VI HS and vs. indacaterol acetate, glycopyrronium bromide, and mometasone (IND/GLY/MF) HS. A network meta-analysis was performed to estimate comparative efficacy of BDP/FOR/GLY against other SITTs. The model analyzed cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER), net monetary benefit (NMB), and was developed from the perspective of England National Health Service (NHS) and Prescribed Specialized Services expenditure (2022 costs). Uncertainty of the inputs was estimated using one-way and probabilistic sensitivity analyses.ResultsBDP/FOR/GLY MS was projected to be a dominant treatment alternative against FF/UMEC/VI MS (£5,121 less costly, gained 0.065 additional QALYs). Similarly, BDP/FOR/GLY HS was a dominant treatment alternative against FF/UMEC/VI HS (£143, 0.003 additional QALYs) and IND/GLY/MF HS (£692 less costly, gained 0.023 additional QALYs). BDP/FOR/GLY MS and HS had 77.1%, 51.3%, and 61.2% likelihoods to be cost-effective vs. FF/UMEC/VI MS, FF/UMEC/VI HS, and IND/GLY/MF HS at the defined willingness-to-pay (WTP) threshold of £20,000 per QALY gained, respectively.ConclusionsBDP/FOR/GLY MS and HS were a dominant treatment alternative compared with FF/UMEC/VI, both MS and HS, and IND/GLY/MF HS in patients with asthma uncontrolled by ICS/LABA.

Abstract licence: CC BY-NC-ND 4.0

IntroductionThe efficacy of the fixed extrafine combination of beclomethasone/formoterol/glycopyrronium (BDP/FF/G 87/5/9 μg) has been evaluated in randomized controlled trials of patients with chronic obstructive pulmonary disease (COPD). However, only few data exist on its effectiveness on small airways dysfunction (SAD).MethodsThe MASCOT (MAnaging Small airways dysfunction in COPD patients in real life on the fixed Triple combination of BDP/FF/G 87/5/9 μg pMDI) prospective observational study evaluated the effectiveness of this combination on SAD in a period of 4 weeks, after direct switch from long-acting β2-agonists (LABA) and long-acting muscarinic antagonists (LAMA) in COPD patients with SAD (forced expiratory flow at 25-75% of the vital capacity, FEF25-75% ResultsBetween May 2022 and July 2023 we recruited 93 COPD patients (mean age 68.5 years, 82% men) with forced expiratory volume in 1 second (FEV1, mean ± SD) 1.53 ± 0.47L (53.4 ± 14.5% predicted) and small airways dysfunction (FEF25-75% predicted 27.7 ± 15.4%). We observed statistically significant improvement in R5-19 between baseline (V1) and follow-up (V2) visits [median (IQR) V2 0.70 (0.41-1.10) vs V1 0.90 (0.60-1.83); mean change (95% CI) -0.49, -0.66 to -0.33 cmH2O/L/sec, p 1 (0.142, 0.078 to 0.205 L, p ConclusionExtrafine triple therapy improved SAD and spirometric parameters, leading to improvement in health status at 4 weeks. These results need to be confirmed in longer studies.

Abstract licence: CC BY-NC

BackgroundCOPD and cardiovascular disease (CVD) are leading causes of death with overlapping and syndemic pathophysiological interactions. Inhaled triple therapies containing inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA) and long-acting β2-agonists (LABA) reduce COPD exacerbation rates and improve lung function versus dual LAMA/LABA therapy. The effect of inhaled triple therapies on combined cardiac and pulmonary (i.e., cardiopulmonary) events in people with COPD and elevated cardiopulmonary risk has not been prospectively tested in randomised clinical trials.MethodsTHARROS is a multinational, event-driven cardiopulmonary outcomes trial evaluating budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy versus glycopyrronium/formoterol fumarate dihydrate dual therapy in patients with COPD and elevated cardiopulmonary risk not using ICS-containing maintenance therapy. Eligibility requirements include symptomatic COPD (COPD Assessment Test scores ≥10) without a requirement for prior COPD exacerbations, blood eosinophils ≥100 cells·mm-3, established CVD or CVD risk based on clinical characteristics, clinical risk scores or imaging-based risk criteria. The composite primary end-point is time to first severe cardiac or COPD event and includes three event types, including severe cardiac events (heart failure acute healthcare visit/hospitalisation, myocardial infarction hospitalisation), severe COPD exacerbations and cardiopulmonary death. Approximately 5000 patients will be randomised to achieve 632 participants with ≥1 primary severe adjudicated cardiopulmonary event.ConclusionThis first-of-its-kind cardiopulmonary outcomes trial will determine the effect of BGF on a novel composite end-point comprising severe cardiopulmonary events in a broad COPD population with elevated cardiopulmonary risk not currently using ICS-containing maintenance therapy.

Abstract licence: CC BY

ObjectiveExtrafine single inhaler triple therapy (efSITT) with beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G 87/5/9 μg) has shown clinical benefits in Chronic Obstructive Pulmonary Disease (COPD) patients, including fewer exacerbations in randomized controlled trials. The IMPROVE study evaluated its real-world effectiveness in Greece in COPD patients previously treated with dual bronchodilation, focusing on exacerbations and other clinical outcomes.MethodsThis prospective, multicenter, observational study was conducted over 52 weeks. The 1103 eligible patients had moderate-to-severe COPD, an indication for treatment with efSITT, and were symptomatic despite receiving dual bronchodilation. The number of exacerbations, COPD Assessment Test (CAT) score, lung function parameters, use of rescue medication and adherence were recorded at baseline (visit 1), 6 months (visit 2), and 12 months (visit 3) after treatment.ResultsThe percentage of patients with ≥1 exacerbation decreased from 100 % at visit 1 to 23.1% at visit 3 (p ConclusionsThe IMPROVE findings indicate that extrafine BDP/FF/G improves clinical outcomes in symptomatic COPD patients previously treated with dual bronchodilation in a real-world setting in Greece.

Abstract licence: CC BY-NC-ND

Marco Mantero,1,2 Dejan Radovanovic,3 Pierachille Santus,3 Francesco Blasi1,2 1Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; 2Internal Medicine Department, Respiratory Unit and Regional Adult Cystic Fibrosis Center, IRCCS Fondazione Ca’ Granda Ospedale Policlinico, Milan, Italy; 3Department of Biomedical and Clinical Sciences (DIBIC), Pulmonary Unit, University of Milan, Ospedale L. Sacco, ASST Fatebenefratelli-Sacco, Milan, Italy Abstract: The major determinant of the decline in lung function, quality of life, and the increased mortality risk in patients with COPD is represented by severe acute exacerbations of the disease, that is, those requiring patients’ hospitalization, constituting a substantial social and health care burden in terms of morbidity and medical resource utilization. Different long-term therapeutic strategies have been proposed so far in order to prevent and/or reduce the clinical and social impact of these events, the majority of which were extrapolated from trials initially focused on the effect of long-acting muscarinic antagonist and subsequently on the efficacy of long-acting β2-agonists in combination or not with inhaled corticosteroids. The option to employ all three classes of molecules combined, despite the limited amount of evidence in our possession, represents a choice currently proposed by international guidelines; however, current recommendations are often based mainly on observational studies or on the results of secondary outcomes in randomized controlled trials. The present narrative review evaluates the available trials that investigated the efficacy of inhaled therapy to prevent COPD exacerbations and especially severe ones, with a particular focus on beclomethasone dipropionate/formoterol/glycopyrronium bromide fixed dose combination, which is the first treatment that comprises all the three drug classes, specifically tested for the prevention of moderate and severe COPD exacerbations. Keywords: hospitalization, COPD, triple therapy, inhaled corticosteroids, formoterol, glycopyrroniu

Abstract licence: CC BY-NC 3.0