Fluticasone furoate 92micrograms/dose / Vilanterol 22micrograms/dose dry powder inhaler

Purpose: Real-life effectiveness data on once-daily single-inhaler triple therapy (odSITT) with the inhaled corticosteroid fluticasone furoate (FF), the long-acting muscarinic antagonist umeclidinium (UMEC), and the long-acting β 2 -agonist vilanterol (VI) in patients with chronic obstructive pulmonary disease (COPD) are important to complement evidence from well-controlled randomized clinical trials. Effectiveness of odSITT was quantified by assessing health status and symptoms in usual care. Patients and Methods: ELLITHE was a single-country (Germany), multicenter, open-label, non-interventional effectiveness study between 2020 and 2022, evaluating the effect of treatment initiation with FF/UMEC/VI 100/62.5/25 μg once-daily via the ELLIPTA inhaler on improvements in clinical outcomes versus baseline in COPD patients. The primary endpoint was the change in the total COPD Assessment Test (CAT) score between baseline and month 12. Key secondary endpoints included change in CAT score over time, occurrence of exacerbations until month 12, changes in forced expiratory volume in one second (FEV 1 ), inhaler adherence, and safety. Results: Nine hundred and six patients were included (age 66.6 years, 55.6% male, mean FEV 1 52.6% of predicted, mean CAT 21.5 units, 1.4 exacerbations/year pre-study). About 63.9% of patients were escalated from dual therapies, and 18% were switched from multiple-inhaler triple therapies. Reductions in CAT score at month 12 were statistically significant and above the threshold of clinical importance (− 2.6 units; p < 0.0001). CAT score also improved at interim visits. CAT improvements were more pronounced in patients with high baseline scores and better inhaler adherence. Exacerbations during follow-up were rare (0.2 events/year) compared to pre-study (1.4 events/year). FEV 1 was improved by 93 mL (p < 0.0001). No new safety effects were observed. Conclusion: In usual care, treatment with odSITT resulted in significant and clinically relevant improvements of CAT score and FEV 1 in COPD patients, regardless of the occurrence of exacerbations. These findings challenge the current guideline recommendations for SITT only in patients experiencing exacerbations. Keywords: CAT score, real-world evidence, lung function, exacerbation, treatment adherence

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<ns4:p><ns4:bold>Background:</ns4:bold> The objective of this pilot study is to assess feasibility (recruitment and retention rates) of conducting a definitive randomized controlled trial (RCT) to investigate the effectiveness of fluticasone-vilanterol (Long-acting beta agonist+ Inhaled corticosteroids; LABA+ICS) in the management of mild asthma in adults, compared with usual care.</ns4:p><ns4:p> <ns4:italic>Methods: In this 8-month parallel two-arm pilot trial we randomly assigned 18 patients with mild asthma in a 1:1 ratio to the treatment (n=10) or usual care (n=8) arms. The treatment group received daily LABA+ICS therapy while the usual care group continued as required SABA or SABA+ICS combination. The main outcome measures were descriptors of study feasibility. Secondary outcomes were asthma control score, quality of life, and the number of asthma exacerbations. </ns4:italic></ns4:p><ns4:p> <ns4:italic>Results: The baseline characteristics of participants did not differ significantly across the two arms at the start of the trial. Because of slow recruitment and limited funding, the study didn’t meet our recruitment target but did successfully meet our retention criteria. At 32 weeks, analysis indicated significant improvement in asthma control scores in the intervention arm (1.31 vs 2.91; 95% CI [0.72, 2.44]; P-value=0.003), but no significant differences were noted in quality-of-life scores (P-value=0.197). There were no significant differences in post-intervention asthma control mean score (P-value=0.361) or QoL mean score (P-value=0.337) between the two arms after adjustment for pre-intervention scores.</ns4:italic></ns4:p><ns4:p> <ns4:bold>Conclusions:</ns4:bold> This pilot RCT indicates that a definitive RCT is feasible in a primary health care setting. We recommend increasing the recruitment rate by relaxing eligibility criteria, extending the timeline, and increasing the number of sites for recruitment.</ns4:p><ns4:p> <ns4:bold>ClincialTrials.gov registration<ns4:underline>: </ns4:underline></ns4:bold>NCT04265105 (11/02/2020)</ns4:p>

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Background A novel fixed-dose combination of vilanterol 25-µg, umeclidinium 62.5-µg, and fluticasone furoate 200-µg (VIL-UME-FF) in dry powder inhaler (DPI) was developed by M/s. Zydus Healthcare Limited for managing persistent asthma. Methods In this phase 3, multicenter, parallel group, open-label, randomized trial, patients received either test (VIL-UME-FF DPI) or reference DPI (indacaterol 150-µg, glycopyrronium 50-µg, and mometasone furoate 160-µg; IND-GLY-MF DPI). The primary endpoint was change from baseline in trough forced expiratory volume-1 (FEV1) at week-12. Secondary endpoints included trough forced vital capacity (FVC), post-bronchodilator FEV1 and FVC, and asthma control test (ACT) score. Results A total of 258 participants (18-65 years) were enrolled (Test: 129; Reference: 129). The least square mean change in trough FEV1 at week-12 was 342.9 (21.3) ml for the test group and 327.6 (21.4) ml for the reference group (p=0.6141). The lower limit of 95% confidence interval for the difference between the groups was -44.19 ml, well-above the predefined non-inferiority margin (-150 ml). At week-12, trough FVC, post-bronchodilator FEV1 and FVC, and ACT scores were comparable between the study groups. Conclusion VIL-UME-FF DPI was non-inferior to IND-GLY-MF DPI in improving trough FEV1 and other efficacy parameters and was well-tolerated in Indian patients with persistent asthma.

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OBJECTIVE: Fluticasone furoate (FF), an inhaled corticosteroid (ICS), and vilanterol (VI), a long-acting beta2 receptor agonist (LABA), is a new combination used in an Ellipta(®) device. This article compares FF-VI to other ICS-LABA combinations available, particularly emphasizing product selection from the patient perspective. DATA SOURCES: A PubMED and EMBASE search completed in October 2015 identified trials using the MeSH terms "fluticasone", "vilanterol", and "asthma". Additional information was gathered from references cited in the identified publications, the manufacturer, package insert, and ClinicalTrials.gov registry. STUDY SELECTION/DATA EXTRACTION: Preference was given to randomized controlled clinical trials. Animal trials, trials for COPD, and non-English sources were excluded. DATA SYNTHESIS: Seven efficacy trials of FF-VI in asthma were identified. Only one (24 weeks) trial compared FF-VI to another ICS-LABA combination (fluticasone propionate-salmeterol). Primary outcomes (usually lung function) and secondary outcomes (eg, quality of life and symptom scores) were comparable. In three FF-VI safety trials, the type and frequency of common adverse reactions (ie, thrush and dysphonia) were similar to those in clinical trials. Over 90% of subjects rated the Ellipta(®) device as "easy to use" and demonstrated correct device technique initially and at 4 weeks. CONCLUSION: Individuals may have drug- and device-specific preferences that should be incorporated into therapeutic decision making. Limited data indicate that clinical and patient-oriented efficacy/safety outcomes of FF-VI are likely comparable to other available combinations for adults with asthma. Patient-friendly features include once-daily dosing, flexibility of dose timing, and design/ease of the use of the device. Additional larger and long-term comparative studies are needed to determine whether these features translate into greater efficacy, safety, patient preference, or adherence versus other ICS-LABA combinations. In the next few years, the availability of less expensive generic ICS-LABA products may strongly influence patient preference.

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INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is associated with exacerbations which can reduce quality of life and increase mortality. Single-inhaler triple therapy (SITT) is recommended for maintenance treatment of COPD among patients experiencing exacerbations despite dual-therapy use. This real-world comparative effectiveness study compared the impact of SITTs, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM), on COPD exacerbations and mortality. METHODS: Medicare Fee-for-Service (FFS) patients with COPD initiated on FF/UMEC/VI or BUD/GLY/FORM were identified from the Komodo Research healthcare claims dataset (01/01/2016-12/31/2023). Overlap weighting based on high-dimensional propensity scores evaluated from patient characteristics was used to adjust for baseline confounding. Primary outcome was annualized rate of moderate-severe COPD exacerbations (per patient-year; PPY) compared using rate ratios (RRs) with 95% confidence intervals (CIs) from weighted Poisson regression models. Secondary and exploratory outcomes were risk of moderate-severe COPD exacerbations and all-cause mortality, respectively, evaluated using Kaplan-Meier analysis and hazard ratios (HR) with 95% CIs from Cox proportional hazard models. A secondary analysis was conducted among a mutually exclusive population with Medicare Advantage, Medicaid, or commercial insurance. RESULTS: Overall, 32,312 FF/UMEC/VI and 12,230 BUD/GLY/FORM Medicare FFS patients were included. After weighting, median follow-up was 9 months. Compared with BUD/GLY/FORM, FF/UMEC/VI users had a 12% lower rate of annualized moderate-severe COPD exacerbations [0.80 and 0.91 PPY; RR (95% CI): 0.88 (0.85-0.92); P < 0.001] and a 10% lower risk of moderate-severe exacerbations at 12 months post-initiation [HR (95% CI): 0.90 (0.87-0.93); P < 0.001], driven by moderate exacerbations. FF/UMEC/VI compared with BUD/GLY/FORM users had 11% lower risk of all-cause mortality at 12 months post-initiation [5.6% vs. 6.4%; HR (95% CI): 0.89 (0.80-0.98); P = 0.020]. Results were consistent among patients with Medicare Advantage, Medicaid, or commercial insurance. CONCLUSIONS: In this real-world comparative effectiveness study, FF/UMEC/VI was associated with significantly lower rate and risk of COPD exacerbations than BUD/GLY/FORM.

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Purpose: Patients with chronic obstructive pulmonary disease (COPD) have been shown to benefit from triple therapy commonly delivered by multiple-inhaler triple therapy (MITT); however, the complexity of MITT regimens may decrease patient adherence. Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), a once-daily single-inhaler triple therapy (SITT), became available in the United States (US) in 2017, but real-world data comparing outcomes for SITT versus MITT are currently limited. This study compared outcomes among patients with COPD initiating MITT versus SITT with FF/UMEC/VI who were either Medicare Advantage with Part D (MAPD) beneficiaries or commercial enrollees in the US. Methods: Retrospective study using administrative claims data from the Optum Research Database for patients with COPD who initiated FF/UMEC/VI or MITT between September 1, 2017, and March 31, 2019 (index date: first pharmacy claim for FF/UMEC/VI cohort; earliest day of ≥ 30 consecutive days-long period of overlap in the day’s supply of all triple therapy components for MITT cohort). COPD exacerbations, adherence to triple therapy, and all-cause and COPD-related health care resource utilization (HCRU) and costs were compared between FF/UMEC/VI and MITT initiators. Results: In total, 4659 FF/UMEC/VI initiators and 9845 MITT initiators for the MAPD population, and 821 FF/UMEC/VI initiators and 1893 MITT initiators for the commercial population were included in the study. MAPD beneficiaries initiating FF/UMEC/VI had a significantly lower annual rate of severe exacerbations compared to MITT initiators (0.26 vs 0.29; p=0.014). They also had a significantly higher mean adherence (proportion of days covered) (0.51 vs 0.37; p< 0.001) and significantly lower all-cause and COPD-related inpatient stays compared to MITT initiators ([32.02% vs 34.27%; p=0.017], [16.09% vs 17.72%; p=0.037]). Trends were similar among the commercial population, but the results were not statistically significant. Conclusion: FF/UMEC/VI initiators had significantly fewer severe exacerbations, higher triple therapy adherence, and lower HCRU costs compared to MITT initiators for MAPD beneficiaries. Plain Language Summary: Triple therapy for chronic obstructive pulmonary disease (COPD) includes the use of several inhalers daily in a respiratory therapy combination known as multiple-inhaler triple therapy (MITT), which can be challenging for patients. However, treatment can be simplified by combining these therapies into just one inhaler, in a respiratory therapy combination known as single-inhaler triple therapy (SITT). As there is currently limited information comparing treatment outcomes in patients using SITT versus those using MITT in the real world, in this study we included Medicare Advantage with Part D (MAPD) beneficiaries and commercial enrollees with COPD who started using either an SITT combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or MITT. More specifically, we looked at flare-ups in COPD symptoms (known as exacerbations), percentage of days that a patient had their medication on hand (known as treatment adherence), and health care utilization and costs. The study was conducted using administrative claims data between September 1, 2016, and March 31, 2020 from the Optum Research Database. For patients who had MAPD insurance, individuals who started FF/UMEC/VI experienced fewer severe exacerbations and increased treatment adherence, as compared to those who started MITT. They also had lower health care utilization and costs compared to those using MITT. Similar results were observed for patients who were commercially enrolled, albeit lacking statistical significance. Overall, the findings of this study indicate that triple therapy with FF/UMEC/VI can improve exacerbations and treatment adherence in patients with COPD and decrease health care utilization and associated costs. Keywords: chronic obstructive pulmonary disease, triple therapy, multiple-inhaler triple therapy, single-inhaler triple therapy, adherence, exacerbations

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Previous real-world evidence suggests that prompt versus delayed initiation of single-inhaler triple therapy (SITT) with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following an exacerbation results in improved clinical outcomes for patients with chronic obstructive pulmonary disease (COPD). This prior study was conducted in the first 2 years following FF/UMEC/VI approval, representing early trends. The current updated analysis aims to further elucidate the real-world evidence for FF/UMEC/VI. This was a retrospective cohort study using the IQVIA PharMetrics® Plus database. Patients with COPD initiating SITT with FF/UMEC/VI within 6 months of an exacerbation (index date) were classified as prompt (≤ 30 days following exacerbation) or delayed (31–180 days) initiators. The baseline period comprised the 12 months prior to index. Inverse probability of treatment weighting was used to balance differences in baseline characteristics between cohorts. COPD exacerbations, hospital readmission rates, and healthcare costs were compared between cohorts post-index. Overall, 5421 patients (prompt, 2057; delayed, 3364) were included. After weighting, baseline characteristics were well balanced between cohorts. For up to 12 months post-index, prompt initiators of FF/UMEC/VI had significantly lower rates of exacerbations per person-year versus delayed initiators (0.74 vs. 1.06; rate ratio 0.70, 95% confidence interval [CI] 0.64–0.77; P < 0.001). A 1-day delay in FF/UMEC/VI initiation was associated with a 0.31% increase in the rate of exacerbations. At 90 days post-index, Kaplan–Meier rates of all-cause (hazard ratio [HR] 0.62, 95% CI 0.45–0.86; P = 0.004) and COPD-related (HR 0.58, 95% CI 0.35–0.98; P = 0.042) hospital readmissions were significantly lower in the prompt versus delayed cohort. Total COPD-related healthcare costs per person per year were significantly lower for patients in the prompt versus delayed cohort. Healthcare providers should consider the positive impact of prompt FF/UMEC/VI initiation on exacerbation rate, hospital readmission rate, and costs when treating patients with COPD at risk of exacerbations. Triple therapy (a combination of three medicines) is recommended for patients with chronic obstructive pulmonary disease (COPD) who experience short-term worsening of symptoms (or COPD attacks). The optimum time for patients who may benefit from triple therapy to initiate their new medication following a COPD attack is still being investigated. This study assesses the effect of initiating treatment with triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) sooner rather than later following a COPD attack. Patients with COPD who experienced a COPD attack and went on to initiate therapy with FF/UMEC/VI were split into two groups—those who initiated FF/UMEC/VI within 30 days of their COPD attack, and those who initiated FF/UMEC/VI between 31 and 180 days following their COPD attack. Patients who initiated FF/UMEC/VI sooner (within 30 days of their original COPD attack) had fewer COPD attacks in the following year compared with patients who initiated FF/UMEC/VI later. Among those who initiated FF/UMEC/VI sooner, there were also fewer patients with hospital readmission, and lower healthcare costs resulting from COPD, compared with patients who initiated FF/UMEC/VI later. The results of this study suggest that healthcare providers should consider prescribing FF/UMEC/VI for patients with COPD as soon as possible following a COPD attack, rather than delaying the start of therapy, and may encourage patients to start taking FF/UMEC/VI sooner rather than later following a COPD attack.

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Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg has been shown to improve lung function and health status, and reduce exacerbations, versus budesonide/formoterol in patients with chronic obstructive pulmonary disease (COPD). We evaluated the non-inferiority of single-inhaler FF/UMEC/VI versus FF/VI + UMEC using two inhalers. Eligible patients with COPD (aged ≥40 years; ≥1 moderate/severe exacerbation in the 12 months before screening) were randomized (1:1; stratified by the number of long-acting bronchodilators [0, 1 or 2] per day during run-in) to receive 24-week FF/UMEC/VI 100/62.5/25 μg and placebo or FF/VI 100/25 μg + UMEC 62.5 μg; all treatments/placebo were delivered using the ELLIPTA inhaler once-daily in the morning. Primary endpoint: change from baseline in trough forced expiratory volume in 1 s (FEV1) at Week 24. The non-inferiority margin for the lower 95% confidence limit was set at − 50 mL. A total of 1055 patients (844 [80%] of whom were enrolled on combination maintenance therapy) were randomized to receive FF/UMEC/VI (n = 527) or FF/VI + UMEC (n = 528). Mean change from baseline in trough FEV1 at Week 24 was 113 mL (95% CI 91, 135) for FF/UMEC/VI and 95 mL (95% CI 72, 117) for FF/VI + UMEC; the between-treatment difference of 18 mL (95% CI -13, 50) confirmed FF/UMEC/VI’s was considered non-inferior to FF/VI + UMEC. At Week 24, the proportion of responders based on St George’s Respiratory Questionnaire Total score was 50% (FF/UMEC/VI) and 51% (FF/VI + UMEC); the proportion of responders based on the Transitional Dyspnea Index focal score was similar (56% both groups). A similar proportion of patients experienced a moderate/severe exacerbation in the FF/UMEC/VI (24%) and FF/VI + UMEC (27%) groups; the hazard ratio for time to first moderate/severe exacerbation with FF/UMEC/VI versus FF/VI + UMEC was 0.87 (95% CI 0.68, 1.12). The incidence of adverse events was comparable in both groups (48%); the incidence of serious adverse events was 10% (FF/UMEC/VI) and 11% (FF/VI + UMEC). Single-inhaler triple therapy (FF/UMEC/VI) is non-inferior to two inhalers (FF/VI + UMEC) on trough FEV1 change from baseline at 24 weeks. Results were similar on all other measures of efficacy, health-related quality of life, and safety. GSK study CTT200812; ClinicalTrials.gov NCT02729051 (submitted 31 March 2016).

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• The analytical method is shown to be robust with the statistical determination of p value is <0.05% • The method consumes lesser mobile phase and diluent and elutes the analyte peaks with in 20 minutes of run time. • With the simple isocratic and sample preparation the 3 analytes are shown good resolution between the analytes. • The analytical method was assessed with the GAC tools includes AGREE, GAPI and Eco-Scale tools, shown the method is environmentally friendly. • The analytical method was found specific, precise and accurate through validation per ICH Q2(R1) guidelines. The combination of Glycopyrronium, Fluticasone, and Vilanterol is utilized to manage chronic obstructive pulmonary disease (COPD) and mitigate asthma symptoms. Glycopyrronium functions as an anticholinergic compound, Fluticasone serves as a corticosteroid that mitigates inflammation, and Vilanterol operates as a long-acting beta-agonist that facilitates the relaxation of the bronchial passages. The simultaneous quantification of Glycopyrronium, Vilanterol, and Fluticasone was accomplished through the utilization of Ultra-High-Performance Liquid Chromatography (UHPLC) employing a Symmetry Shield C18 column (4.6 mm x 100 mm ID, 2.6µm particle size), with a flow rate of 0.6 mL/min, and a gradient elution employing pH 3.0 Ammonium Formate as mobile phase A and ethanol as mobile phase B. By the guidelines delineated by the International Conference on Harmonization (ICH) Q2, method validation encompassed specificity (with the purity angle for the three chromatographic peaks exceeding the purity threshold under all degradation conditions), linearity (exhibiting an R² value greater than 0.999 from the lower limit of quantification to 200%), accuracy (with recovery rates ranging from 95% to 105%), robustness (the influence of variations in mobile phase buffer pH, column temperature, and flow rate was scrutinized utilizing Analytical Quality by Design principles), and assessments of method precision. The Green Analytical Procedure Index (GAPI), Analytical Greenness (AGREE), and analytical eco-scale evaluations substantiated the method's advantageous characteristics regarding environmental sustainability.

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Purpose: Long-acting bronchodilator (LABD) therapy is recommended for maintenance treatment in most patients with chronic obstructive pulmonary disease (COPD). However, triple therapy (TT; dual LABDs + inhaled corticosteroid [ICS]) is often used as first-line maintenance treatment. The benefits of TT versus dual LABDs as first-line treatments are unknown, necessitating an evaluation of its effectiveness and costs versus non-ICS alternatives. Patients and Methods: This retrospective study assessed administrative claims of maintenance treatment–naive patients in the United States with COPD aged ≥ 40 years initiating single-inhaler fluticasone furoate+umeclidinium+vilanterol (FF+UMEC+VI) or tiotropium+olodaterol (TIO+OLO). Patients were propensity score–matched (1:1) and followed for up to 12 months. The primary outcome was time to first COPD exacerbation. Secondary outcomes included time to first pneumonia diagnosis, pneumonia-related hospitalization, healthcare resource utilization (HCRU), and costs. COPD exacerbation and pneumonia risk were assessed using Cox proportional hazards regression. Results: A total of 5,121 and 3,996 patients met the eligibility criteria for the FF+UMEC+VI and TIO+OLO groups, respectively. Outcomes were assessed among 2,951 matched pairs. The risk of moderate or severe COPD exacerbation was not significantly different between FF+UMEC+VI and TIO+OLO groups (hazard ratio [HR] [95% confidence interval {CI}]: 1.13 [0.99– 1.29]; P =0.064). The risks of pneumonia (HR [95% CI]: 1.04 [0.85– 1.27]; P =0.723) and pneumonia-related hospitalization (HR [95% CI]: 1.18 [0.78– 1.79]; P =0.429) were also not significantly different between the groups. There were no significant differences in HCRU events or all-cause costs; however, FF+UMEC+VI initiators incurred greater COPD- and/or pneumonia-related pharmacy costs than TIO+OLO initiators (FF+UMEC+VI: &dollar;2,934 [&dollar;2,827–&dollar;3,041], TIO+OLO: &dollar;1,994 [&dollar;1,915–&dollar;2,073]; P < 0.001). Conclusion: In maintenance treatment–naive patients, FF+UMEC+VI offered no reduction in COPD exacerbation risk over TIO+OLO and resulted in higher pharmacy costs related to COPD and/or pneumonia treatment. These results support treatment recommendations for LAMA+LABA as initial maintenance therapy. Trial Registration: ClinicalTrials.gov identifier - NCT05169424. Plain Language Summary: Chronic obstructive pulmonary disease (COPD) is a disease affecting the lungs, which causes symptoms such as shortness of breath, cough, and phlegm. The goal of COPD management is to control the symptoms and reduce the risk of flare-ups (exacerbations). COPD maintenance treatments include medications called inhaled corticosteroids (ICS) that reduce airway inflammation and bronchodilators that either prevent the closing of airways (eg, long-acting muscarinic antagonists [LAMAs]), or keep them open longer (eg, long-acting beta2-agonists [LABAs]). National and international guidelines recommend triple therapy (ICS+LAMA+LABA) for symptomatic patients who continue to have frequent exacerbations despite LAMA+LABA dual therapy. However, the use of triple therapy as the first treatment choice is common in everyday clinical practice, even in patients who have not received any long-acting bronchodilators in the past (maintenance treatment–naive patients). Therefore, our study compared the clinical and economic outcomes in maintenance treatment–naive patients who were given single-inhaler triple therapy (LAMA+LABA+ICS) with those who were given dual therapy (LAMA+LABA). In our study, the risk of COPD flare-up, pneumonia, and hospitalization due to pneumonia was not different between patients who received triple and dual therapy, indicating no significant benefit of triple therapy over dual therapy. Additionally, triple therapy resulted in higher pharmacy costs. We conclude that for patients with COPD starting maintenance treatment, dual therapy was not only as effective as triple therapy in managing COPD but also had economic benefits. Keywords: dual bronchodilator therapy, exacerbation risk, health outcomes, maintenance treatment–naive, treatment initiation, triple therapy

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