Umeclidinium bromide 65micrograms/dose dry powder inhaler

Introduction: Monoclonal antibodies (mAbs) against cytokines and chemokines or their receptors promise to be a potential therapeutic option to address chronic obstructive pulmonary disease (COPD). We aim to provide a comprehensive literature review of the improvement in FEV1 and safety when comparing mAbs with conventional dichotomous agents. Methods: We systematically searched 3 electronic databases (PubMed, EMBASE, and CENTRAL) up to August 1, 2023 to collect eligible randomized controlled trials (RCTs). A frequentist network meta-analysis using a random-effects model was deployed to calculate mean differences (MD) for FEV1, relative risk (RR) of treatment-emergent adverse events (TEAEs), and estimate the surface under cumulative rankings (SUCRA). A higher SUCRA indicates a better outcome. Results: This study included 23 RCTs involving a total of 20,853 patients. Overall, except for Dupilumab, mAbs did not significantly improve FEV1 compared to traditional conventional dichotomous agents. Among all the interventions included, Aclidinium bromide/Formoterol (AB/FF) (SUCRA 97.7%) ranked highest, followed by Umeclidinium/vilanterol (UMEC/VI) (SUCRA 93.5%), and Glycopyrrolate Formoterol Fumarate (GFF) (SUCRA 84.7%). Dupilumab (SUCRA 66.9%) ranked the fourth among all interventions but ranked the first among all the mAbs. Importantly, all mAbs demonstrated a good safety profile compared with placebo. Conclusion: Considering the improvement in FEV1 and its safety, the development of mAbs for COPD still holds significant clinical potential. Systematic review registration: PROSPERO, CRD42023452714.

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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). 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. 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. 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.

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Recent literature has shown that triple therapy is more effective than dual therapy for individuals with uncontrolled asthma. However, the comparative efficacy between different triple therapies remains unclear. 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. A systematic literature review identified randomized control trials on adult patients with uncontrolled asthma. Two separate networks were constructed according to patients' previous inhaled-corticosteroid dosage. Network meta-analyses evaluated severe and moderate-to-severe exacerbations, pre-dose forced expiratory volume, and asthma control questionnaire responses at 52 (± 3) weeks. 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 or trend for improvement in terms of reducing the rate of severe and moderate-to-severe exacerbations.

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BACKGROUND: In 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. METHODS: Markov 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. RESULTS: BDP/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. CONCLUSIONS: BDP/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.

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Background: ATS and GOLD guidelines recommend treating low-exacerbation risk COPD patients with dual (LAMA/LABA) agents and reserving triple therapy (TT; LAMA/LABA and inhaled corticosteroids [ICS]) for severe cases with higher-exacerbation risk. However, TT often is prescribed across the COPD spectrum. This study compared COPD exacerbations, pneumonia diagnosis, healthcare resource utilization, and costs for patients initiating tiotropium bromide/olodaterol (TIO/OLO) and a TT, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), stratified by exacerbation history. Methods: COPD patients who initiated TIO/OLO or FF/UMEC/VI between 06/01/2015-11/30/2019 (index date=first pharmacy fill-date with ≥30 consecutive treatment days) were identified from the Optum Research Database. Patients were ≥40 years old and continuously enrolled for 12 months during the baseline period and ≥30 days during follow-up. Patients were stratified into GOLD A/B (0-1 baseline non-hospitalized exacerbation), No exacerbation (subset of GOLD A/B), and GOLD C/D (≥2 non-hospitalized and/or ≥1 hospitalized baseline exacerbation). Baseline characteristics were balanced with propensity score matching (1:1). Adjusted risks of exacerbation, pneumonia diagnosis, and COPD and/or pneumonia-related utilization and costs were evaluated. Results: Adjusted exacerbation risk was similar in GOLD A/B and No exacerbation subgroups, and lower in GOLD C/D for FF/UMEC/VI versus TIO/OLO initiators (hazard ratio: 0.87; 95% CI: 0.78, 0.98, p=0.020). Adjusted pneumonia risk was similar between cohorts across the GOLD subgroups. Adjusted COPD and/or pneumonia-related population annualized pharmacy costs were significantly higher for FF/UMEC/VI versus TIO/OLO initiators across subgroups, p<0.001. Adjusted COPD and/or pneumonia-related population annualized total healthcare costs were significantly higher for FF/UMEC/VI versus TIO/OLO initiators in the GOLD A/B and No exacerbation, subgroups, p<0.001 (cost ratio [95% CI]: 1.25 [1.13, 1.38] and 1.21 [1.09, 1.36], respectively), but similar in the GOLD C/D subgroup. Conclusion: These real-world results support ATS and GOLD recommendations for treating low-exacerbation risk COPD patients with dual bronchodilators and TT for more severe, higher-exacerbation risk COPD patients.

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Purpose: -agonist combination umeclidinium/vilanterol (UMEC/VI) versus tiotropium bromide/olodaterol (TIO/OLO) for chronic obstructive pulmonary disease (COPD) is limited. This study compared rescue medication prescriptions in patients with COPD in England receiving UMEC/VI versus TIO/OLO. Patients and Methods: This retrospective cohort study used primary care data from the Clinical Practice Research Datalink Aurum database linked with secondary care administrative data from Hospital Episode Statistics. Patients with a COPD diagnosis at age ≥35 years were included (indexed) following initiation of single-inhaler UMEC/VI or TIO/OLO between July 1, 2015, and September 30, 2019. Outcomes included the number of rescue medication prescriptions at 12-months (primary), and at 6-, 18- and 24-months (secondary), adherence at 6-, 12-, 18- and 24-months post-index, defined as proportion of days covered ≥80% (secondary), and time-to-initiation of triple therapy (exploratory). Inverse probability of treatment weighting (IPTW) was used to balance potential confounding baseline characteristics. Superiority of UMEC/VI versus TIO/OLO for the primary outcome of rescue medication prescriptions was assessed using an intention-to-treat analysis with a p-value < 0.05. Results: In total, 8603 patients were eligible (UMEC/VI: n = 6536; TIO/OLO: n = 2067). Following IPTW, covariates were well balanced across groups. Patients initiating UMEC/VI had statistically significantly fewer (mean [standard deviation]; p-value) rescue medication prescriptions versus TIO/OLO in both the unweighted (4.84 [4.78] vs 5.68 [5.00]; p < 0.001) and weighted comparison (4.91 [4.81] vs 5.48 [5.02]; p = 0.0032) at 12 months; consistent results were seen at all timepoints. Adherence was numerically higher for TIO/OLO versus UMEC/VI at all timepoints. Time-to-triple therapy was similar between treatment groups. Conclusion: UMEC/VI was superior to TIO/OLO in reducing rescue medication prescriptions at 12 months after treatment initiation in a primary care cohort in England, potentially suggesting improvements in symptom control with UMEC/VI compared with TIO/OLO.

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