Vilanterol

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David A. Lipson - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and safety of umeclidinium Vilanterol in current and former smokers with copd a prespecified analysis of the emax trial
    Advances in Therapy, 2021
    Co-Authors: Leif Bjermer, François Maltais, Lee Tombs, David A. Lipson, Paul W. Jones, I Boucot, Chris Compton, C Vogelmeier, Edward Kerwin
    Abstract:

    Smoking may reduce the efficacy of inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD), but its impact on bronchodilator efficacy is unclear. This analysis of the EMAX trial explored efficacy and safety of dual- versus mono-bronchodilator therapy in current or former smokers with COPD. The 24-week EMAX trial evaluated lung function, symptoms, health status, exacerbations, clinically important deterioration, and safety with umeclidinium/Vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving ICS. Current and former smoker subgroups were defined by smoking status at screening. The analysis included 1203 (50%) current smokers and 1221 (50%) former smokers. Both subgroups demonstrated greater improvements from baseline in trough FEV1 at week 24 (primary endpoint) with umeclidinium/Vilanterol versus umeclidinium (least squares [LS] mean difference, mL [95% CI]; current: 84 [50, 117]; former: 49 [18, 80]) and salmeterol (current: 165 [132, 198]; former: 117 [86, 148]) and larger reductions in rescue medication inhalations/day over 24 weeks versus umeclidinium (LS mean difference [95% CI]; current: − 0.42 [− 0.63, − 0.20]; former: − 0.25 − 0.44, − 0.05]) and salmeterol (current: − 0.28 [− 0.49, − 0.06]; former: − 0.29 [− 0.49, − 0.09]). Umeclidinium/Vilanterol increased the odds (odds ratio [95% CI]) of clinically significant improvement at week 24 in Transition Dyspnea Index versus umeclidinium (current: 1.54 [1.16, 2.06]; former: 1.32 [0.99, 1.75]) and salmeterol (current: 1.37 (1.03, 1.82]; former: 1.60 [1.20, 2.13]) and Evaluating Respiratory Symptoms–COPD versus umeclidinium (current: 1.54 [1.13, 2.09]; former: 1.50 [1.11, 2.04]) and salmeterol (current: 1.53 [1.13, 2.08]; former: 1.53 [1.12, 2.08]). All treatments were well tolerated in both subgroups. In current and former smokers, umeclidinium/Vilanterol provided greater improvements in lung function and symptoms versus umeclidinium and salmeterol, supporting consideration of dual-bronchodilator therapy in symptomatic patients with COPD regardless of their smoking status. Patients with chronic obstructive pulmonary disease (COPD) often require daily medication to control their COPD. Many patients with COPD are smokers, and smoking is one of the most common causes of COPD. This means that it is important to find out whether COPD medications are effective in both smokers and nonsmokers. We analyzed data from a clinical trial (EMAX) that investigated the use of a combination of two bronchodilators, which are inhaled medications that help to open the airways. We compared umeclidinium/Vilanterol, a dual-bronchodilator combination, with a single bronchodilator (either umeclidinium or salmeterol) over 6 months. We found that both current and former smokers who were treated with umeclidinium/Vilanterol had larger improvements in lung function than those receiving umeclidinium or salmeterol. Current or former smokers who were treated with umeclidinium/Vilanterol used their reliever inhaler less than those treated with umeclidinium or salmeterol. Patients treated with umeclidinium/Vilanterol were generally less likely to experience disease worsening compared with umeclidinium or salmeterol if they were former smokers, or compared with salmeterol if they were current smokers. Our findings suggest that umeclidinium/Vilanterol may be more effective than a single bronchodilator for daily treatment of patients with COPD who are current or former smokers. Physicians should consider prescribing a combination of two bronchodilators to patients who have symptoms, whether or not they currently smoke, as well as encouraging smoking cessation for all patients.

  • the effect of inhaled corticosteroid withdrawal and baseline inhaled treatment on exacerbations in the impact study a randomized double blind multicenter clinical trial
    American Journal of Respiratory and Critical Care Medicine, 2020
    Co-Authors: Meilan K Han, Mark T. Dransfield, Sally Kilbride, Gerard J Criner, David M G Halpin, Elaine C Jones, Peter Lange, Sally Lettis, David A. Lipson
    Abstract:

    Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/Vilanterol (VI) significantly reduced exacerb...

  • efficacy of umeclidinium Vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with copd not receiving inhaled corticosteroids the emax randomised trial
    Respiratory Research, 2019
    Co-Authors: François Maltais, Lee Tombs, David A. Lipson, Paul W. Jones, Leif Bjermer, Edward Kerwin, Michael L Watkins, I Boucot, Chris Compton
    Abstract:

    Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus mono-bronchodilation in improving symptoms and preventing short-term disease worsening/treatment failure in low exacerbation risk patients with chronic obstructive pulmonary disease (COPD) not receiving inhaled corticosteroids. The 24-week, double-blind, double-dummy, parallel-group Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised patients at low exacerbation risk not receiving inhaled corticosteroids, to umeclidinium/Vilanterol 62.5/25 μg once-daily, umeclidinium 62.5 μg once-daily or salmeterol 50 μg twice-daily. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at Week 24. The study was also powered for the secondary endpoint of Transition Dyspnoea Index at Week 24. Other efficacy assessments included spirometry, symptoms, heath status and short-term disease worsening measured by the composite endpoint of clinically important deterioration using three definitions. Change from baseline in trough FEV1 at Week 24 was 66 mL (95% confidence interval [CI]: 43, 89) and 141 mL (95% CI: 118, 164) greater with umeclidinium/Vilanterol versus umeclidinium and salmeterol, respectively (both p < 0.001). Umeclidinium/Vilanterol demonstrated consistent improvements in Transition Dyspnoea Index versus both monotherapies at Week 24 (vs umeclidinium: 0.37 [95% CI: 0.06, 0.68], p = 0.018; vs salmeterol: 0.45 [95% CI: 0.15, 0.76], p = 0.004) and all other symptom measures at all time points. Regardless of the clinically important deterioration definition considered, umeclidinium/Vilanterol significantly reduced the risk of a first clinically important deterioration compared with umeclidinium (by 16–25% [p < 0.01]) and salmeterol (by 26–41% [p < 0.001]). Safety profiles were similar between treatments. Umeclidinium/Vilanterol consistently provides early and sustained improvements in lung function and symptoms and reduces the risk of deterioration/treatment failure versus umeclidinium or salmeterol in symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids. These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group.

  • population pharmacokinetic analysis of fluticasone furoate umeclidinium Vilanterol via a single inhaler in patients with copd
    The Journal of Clinical Pharmacology, 2018
    Co-Authors: Rashmi Mehta, Noushin Brealey, Eleni Pefani, Misba Beerahee, Helen Barnacle, Ruby Birk, Chang-qing Zhu, David A. Lipson
    Abstract:

    A population pharmacokinetic analysis was conducted from a subset of samples obtained from the Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy trial to characterize the pharmacokinetics of fluticasone furoate, umeclidinium, and Vilanterol in patients with symptomatic COPD following treatment with fluticason furoate-umeclidinium-Vilanterol combined in a single inhaler. This was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticason furoate-umeclidinium-Vilanterol, 100 μg/62.5 μg/25 μg; Ellipta inhaler) with twice-daily dual therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). The analyses were conducted in a subset of 74 patients who received fluticason furoate-umeclidinium-Vilanterol and provided serial or sparse samples. Monte Carlo simulations and a model-based estimation approach both indicated that systemic drug concentrations of fluticasone furoate, umeclidinium, and Vilanterol after administration of fluticason furoate-umeclidinium-Vilanterol triple combination therapy from a single inhaler were within the ranges observed following administration of these drugs as monotherapy (fluticasone furoate, umeclidinium, and Vilanterol) or as dual-combination therapy (fluticasone furoate/Vilanterol or umeclidinium/Vilanterol).

  • once daily single inhaler triple versus dual therapy in patients with copd
    The New England Journal of Medicine, 2018
    Co-Authors: David A. Lipson, Noushin Brealey, Mark T. Dransfield, Frank Barnhart, Gerard J Criner, David M G Halpin, Meilan K Han, Jean Brooks, Nicola C Day, Elaine C Jones
    Abstract:

    Abstract Background The benefits of triple therapy for chronic obstructive pulmonary disease (COPD) with an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA), as compared with dual therapy (either inhaled glucocorticoid–LABA or LAMA–LABA), are uncertain. Methods In this randomized trial involving 10,355 patients with COPD, we compared 52 weeks of a once-daily combination of fluticasone furoate (an inhaled glucocorticoid) at a dose of 100 μg, umeclidinium (a LAMA) at a dose of 62.5 μg, and Vilanterol (a LABA) at a dose of 25 μg (triple therapy) with fluticasone furoate–Vilanterol (at doses of 100 μg and 25 μg, respectively) and umeclidinium–Vilanterol (at doses of 62.5 μg and 25 μg, respectively). Each regimen was administered in a single Ellipta inhaler. The primary outcome was the annual rate of moderate or severe COPD exacerbations during treatment. Results The rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, as...

Mark T. Dransfield - One of the best experts on this subject based on the ideXlab platform.

  • informing the pathway of copd treatment impact trial single inhaler triple therapy fluticasone furoate umeclidinium Vilanterol versus fluticasone furoate Vilanterol and umeclidinium Vilanterol in patients with copd analysis of the western europe and north america regions
    Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, 2021
    Co-Authors: Arnaud Bourdin, Mark T. Dransfield, Gerard J Criner, David M G Halpin, Meilan K Han, Elaine C Jones, Peter Lange, Gilles Devouassoux, Ravi Kalhan, Sally Lettis
    Abstract:

    Background The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/Vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings. Methods IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed. Results Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe. Conclusion Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence. Clinical Trial Registration NCT02164513.

  • informing the pathway of copd treatment single inhaler triple therapy fluticasone furoate umeclidinium Vilanterol versus fluticasone furoate Vilanterol and umeclidinium Vilanterol in patients with copd analysis of the western europe and north america regions
    Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, 2020
    Co-Authors: Arnaud Bourdin, Mark T. Dransfield, Gerard J Criner, David M G Halpin, Meilan K Han, Elaine C Jones, Peter Lange, Gilles Devouassoux, Ravi Kalhan, Sally Lettis
    Abstract:

    Background The IMPACT trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/Vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings. Methods IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe (WE) and North America (NA) populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed. Results Overall, 10,355 patients were enrolled, 3164 from WE, 2639 from NA. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in WE (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and NA (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in WE, but not NA. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in NA but not WE. Conclusion Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in WE and NA; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.

  • the effect of inhaled corticosteroid withdrawal and baseline inhaled treatment on exacerbations in the impact study a randomized double blind multicenter clinical trial
    American Journal of Respiratory and Critical Care Medicine, 2020
    Co-Authors: Meilan K Han, Mark T. Dransfield, Sally Kilbride, Gerard J Criner, David M G Halpin, Elaine C Jones, Peter Lange, Sally Lettis, David A. Lipson
    Abstract:

    Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/Vilanterol (VI) significantly reduced exacerb...

  • single inhaler triple therapy fluticasone furoate umeclidinium Vilanterol versus fluticasone furoate Vilanterol and umeclidinium Vilanterol in patients with copd results on cardiovascular safety from the impact trial
    Respiratory Research, 2020
    Co-Authors: Nicola C Day, Mark T. Dransfield, Sally Kilbride, Gerard J Criner, David M G Halpin, Meilan K Han, Elaine C Jones, Subramanya Kumar, Morrys C Kaisermann, Peter Lange
    Abstract:

    This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/Vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy. IMPACT was a 52-week, randomized, double-blind, multicenter Phase III study comparing the efficacy and safety of FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC/VI 62.5/25 mcg in patients ≥40 years of age with symptomatic chronic obstructive pulmonary disease (COPD) and ≥1 moderate/severe exacerbation in the previous year. The inclusion criteria for the study were intentionally designed to permit the enrollment of patients with significant concurrent CV disease/risk. CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death. Baseline CV risk factors were similar across treatment groups. Overall, 68% of patients (n = 7012) had ≥1 CV risk factor and 40% (n = 4127) had ≥2. At baseline, 29% of patients reported a current/past cardiac disorder and 58% reported a current/past vascular disorder. The proportion of patients with on-treatment CVAESI was 11% for both FF/UMEC/VI and UMEC/VI, and 10% for FF/VI. There was no statistical difference for FF/UMEC/VI versus FF/VI or UMEC/VI in TTF CVAESI (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.85, 1.11; p = 0.711 and HR: 0.92, 95% CI: 0.78, 1.08; p = 0.317, respectively) nor TTF CVAESI leading to hospitalization/prolonged hospitalization or death (HR: 1.19, 95% CI: 0.93, 1.51; p = 0.167 and HR: 0.96, 95% CI: 0.72, 1.27; p = 0.760, respectively). On-treatment MACE occurred in ≤3% of patients across treatment groups, with similar prevalence and rates between treatments. In a symptomatic COPD population with a history of exacerbations and a high rate of CV disease/risk, the proportion of patients with CVAESI and MACE was 10–11% and 1–3%, respectively, across treatment arms, and the risk of CVAESI was low and similar across treatment arms. There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI. NCT02164513 (GSK study number CTT116855).

  • informing the pathway of copd treatment etude impact triple therapie en un inhalateur unique furoate de fluticasone umeclidinium Vilanterol comparee a furoate de fluticasone Vilanterol et umeclidinium Vilanterol chez les patients atteints de bronchopneumopathie chronique obstructive bpco analyse basee sur les traitements de la bpco a l inclusion
    Revue des Maladies Respiratoires Actualités, 2020
    Co-Authors: Dave Singh, Mark T. Dransfield, Sally Kilbride, Meilan K Han, Peter Lange, Gj Criner, Ce Jones, Dmg Halpin, David A Lomas, Fernando J Martinez
    Abstract:

    Introduction IMPACT etude multicentrique, en double aveugle, randomisee de 52 semaines a compare Furoate de Fluticasone/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/62,5/25 μg a Furoate de Fluticasone/Vilanterol (FF/VI) 100/25 μg et Umeclidinium/Vilanterol (UMEC/VI) 62,5/25 μg chez des patients ≥ 40 ans avec une BPCO symptomatique et des antecedents d’exacerbations (n = 10 355). Le critere d’evaluation principal etait le taux annuel d’exacerbations moderees/severes (M/S). Presentation ci-apres des analyses selon les traitements de la BPCO a l’inclusion. Methodes Des analyses post-hoc, des taux annuels d’exacerbations M/S et severe, du VEMS residuel et du SGRQ etaient menees pour FF/UMEC/VI vs UMEC/VI et FF/VI dans les sous-groupes suivants : CSI + LAMA + LABA, LAMA + LABA, CSI + LABA, et LAMA. Etude non concue pour analyser les differences entre les traitements dans ces resultats par s/groupes. Resultats Dans tous les bras de traitement, les taux annuels d’exacerbations M/S variaient selon le traitement a l’inclusion ( Fig. 1 ). Chez les patients sous CSI + LAMA + LABA ou CSI + LABA a l’inclusion, FF/UMEC/VI a significativement reduit les taux annuels d’exacerbations M/S vs FF/VI et UMEC/VI. Chez les patients sous LAMA + LABA a l’inclusion, FF/UMEC/VI a significativement reduit les taux annuels d’exacerbations M/S vs FF/VI, une reduction a egalement ete observee vs UMEC/VI mais n’etait pas statistiquement significative. Aucune difference statistiquement significative n’a ete observee entre les taux annuels d’exacerbations M/S avec FF/UMEC/VI vs comparateurs chez les patients sous LAMA. Des reductions significatives des taux annuels d’exacerbations severe ont ete observees avec FF/UMEC/VI vs comparateurs chez ceux sous CSI + LAMA + LAMA a l’inclusion et vs UMEC/VI chez ceux sous CSI + LABA ; les autres comparaisons n’etaient pas statistiquement significatives. Des ameliorations significatives du VEMS residuel ont ete observees avec FF/UMEC/VI vs comparateurs, independamment de l’utilisation des traitements a l’inclusion. FF/UMEC/VI a significativement ameliore le score SGRQ vs comparateurs CSI + LAMA + LABA ou CSI + LABA a l’inclusion et vs FF/VI chez ceux sous LAMA ; les resultats du SGRQ etaient en faveur de FF/UMEC/VI pour d’autres comparaisons mais n’etaient pas statistiquement significatifs ( Fig. 1 ). Conclusion Les avantages de FF/UMEC/VI vs FF/VI et UMEC/VI ont ete demontres sur plusieurs criteres d’evaluation chez des patients sous CSI + LAMA + LABA ou CSI + LABA, conformement aux resultats globaux de la population en ITT. Des benefices ont egalement ete observes chez des patients sous LAMA/LABA avec FF/UMEC/VI vs FF/VI, mais aucune difference significative entre les traitements n’a ete observee chez ceux sous LAMA a l’inclusion.

Noushin Brealey - One of the best experts on this subject based on the ideXlab platform.

  • population pharmacokinetic analysis of fluticasone furoate umeclidinium Vilanterol via a single inhaler in patients with copd
    The Journal of Clinical Pharmacology, 2018
    Co-Authors: Rashmi Mehta, Noushin Brealey, Eleni Pefani, Misba Beerahee, Helen Barnacle, Ruby Birk, Chang-qing Zhu, David A. Lipson
    Abstract:

    A population pharmacokinetic analysis was conducted from a subset of samples obtained from the Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy trial to characterize the pharmacokinetics of fluticasone furoate, umeclidinium, and Vilanterol in patients with symptomatic COPD following treatment with fluticason furoate-umeclidinium-Vilanterol combined in a single inhaler. This was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticason furoate-umeclidinium-Vilanterol, 100 μg/62.5 μg/25 μg; Ellipta inhaler) with twice-daily dual therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). The analyses were conducted in a subset of 74 patients who received fluticason furoate-umeclidinium-Vilanterol and provided serial or sparse samples. Monte Carlo simulations and a model-based estimation approach both indicated that systemic drug concentrations of fluticasone furoate, umeclidinium, and Vilanterol after administration of fluticason furoate-umeclidinium-Vilanterol triple combination therapy from a single inhaler were within the ranges observed following administration of these drugs as monotherapy (fluticasone furoate, umeclidinium, and Vilanterol) or as dual-combination therapy (fluticasone furoate/Vilanterol or umeclidinium/Vilanterol).

  • once daily single inhaler triple versus dual therapy in patients with copd
    The New England Journal of Medicine, 2018
    Co-Authors: David A. Lipson, Noushin Brealey, Mark T. Dransfield, Frank Barnhart, Gerard J Criner, David M G Halpin, Meilan K Han, Jean Brooks, Nicola C Day, Elaine C Jones
    Abstract:

    Abstract Background The benefits of triple therapy for chronic obstructive pulmonary disease (COPD) with an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA), as compared with dual therapy (either inhaled glucocorticoid–LABA or LAMA–LABA), are uncertain. Methods In this randomized trial involving 10,355 patients with COPD, we compared 52 weeks of a once-daily combination of fluticasone furoate (an inhaled glucocorticoid) at a dose of 100 μg, umeclidinium (a LAMA) at a dose of 62.5 μg, and Vilanterol (a LABA) at a dose of 25 μg (triple therapy) with fluticasone furoate–Vilanterol (at doses of 100 μg and 25 μg, respectively) and umeclidinium–Vilanterol (at doses of 62.5 μg and 25 μg, respectively). Each regimen was administered in a single Ellipta inhaler. The primary outcome was the annual rate of moderate or severe COPD exacerbations during treatment. Results The rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, as...

  • single inhaler fluticasone furoate umeclidinium Vilanterol versus fluticasone furoate Vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease a randomized non inferiority study
    Respiratory Research, 2018
    Co-Authors: Peter R Bremner, Noushin Brealey, Ruby Birk, Chang-qing Zhu, Afisi S Ismaila, David A. Lipson
    Abstract:

    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).

  • Preventing clinically important deterioration with single-inhaler triple therapy in COPD
    European Respiratory Society, 2018
    Co-Authors: Ian Naya, Noushin Brealey, Ruby Birk, Chang-qing Zhu, David A. Lipson, Chris Compton, Maggie Tabberer, Afisi S Ismaila, Gerard Criner
    Abstract:

    Clinically important deterioration (CID) is a novel composite end-point (lung function, health status, exacerbations) for assessing disease stability in patients with chronic obstructive pulmonary disease (COPD). We prospectively analysed CID in the FULFIL study. FULFIL (ClinicalTrials.gov NCT02345161; randomised, double-blind, double-dummy, multicentre study) compared 24 weeks of once daily, single-inhaler fluticasone furoate/umeclidinium/Vilanterol (FF/UMEC/VI) 100/62.5/25 µg with twice daily budesonide/formoterol (BUD/FOR) 400/12 μg in patients aged ≥40 years with symptomatic advanced COPD (Global Initiative for Chronic Obstructive Lung Disease group D). A subset of patients received study treatment for up to 52 weeks. Time to first CID event was assessed over 24 and 52 weeks using two approaches for the health status component: St George's Respiratory Questionnaire and COPD assessment test. FF/UMEC/VI significantly reduced the risk of a first CID event by 47–52% versus BUD/FOR in the 24- and 52-week populations using both CID definitions (p

  • fulfil trial once daily triple therapy for patients with chronic obstructive pulmonary disease
    American Journal of Respiratory and Critical Care Medicine, 2017
    Co-Authors: Noushin Brealey, Helen Barnacle, Ruby Birk, David A. Lipson, Nicholas Locantore, David A Lomas, Andrea Ludwigsengpiel, Rajat Mohindra, Maggie Tabberer
    Abstract:

    Rationale: Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited.Objectives: We compared the effects of once-daily triple therapy on lung function and health-related quality of life with twice-daily ICS/LABA therapy in patients with COPD.Methods: The FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/Vilanterol 100 μg/62.5 μg/25 μg; ELLIPTA inhaler) with twice-daily ICS/LABA therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). A patient subgroup remained on blinded treatment for up to 52 weeks. Co–primary endpoints were change from baseline in trough FEV1 and in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 24.Measurements and Main Results...

Courtney Crim - One of the best experts on this subject based on the ideXlab platform.

  • cardiac troponin i and cardiovascular risk in patients with chronic obstructive pulmonary disease
    Journal of the American College of Cardiology, 2018
    Co-Authors: Philip D Adamson, Julie A Anderson, Robert D Brook, Peter M A Calverley, Bartolome R Celli, Courtney Crim, Fernando J Martinez, Nicholas J Cowans, Ian J Dixon, David E Newby
    Abstract:

    Abstract Background Patients with chronic obstructive pulmonary disease (COPD) have increased risk of cardiovascular events. Objectives This study evaluated the association between high-sensitivity cardiac troponin I concentration and cardiovascular events in patients with COPD and heightened cardiovascular risk. Methods In a double-blind randomized controlled trial, 16,485 patients with COPD and cardiovascular disease or risk factors were randomized to once daily inhaled placebo, fluticasone furoate (100 μg), Vilanterol (25 μg), or their combination. Plasma high-sensitivity cardiac troponin I concentrations were measured in a subgroup of 1,599 patients. Outcomes were on-treatment cardiovascular events and COPD exacerbations over a median of 18 months, and cardiovascular death over a median of 27 months. Results Baseline plasma cardiac troponin I concentrations were above the limit of detection (1.2 ng/l) in 1,542 (96%) patients. Concentrations were unaffected by inhaled therapies at 3 months (p > 0.05). Compared with the lowest quintile (cardiac troponin  Conclusions In patients with COPD and heightened cardiovascular risk, plasma cardiac troponin I concentrations are a specific and major indicator of future cardiovascular events and cardiovascular death. Inhaled therapies did not affect cardiac troponin I concentrations consistent with their neutral effect on mortality and cardiovascular outcomes. (Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease [SUMMIT]; NCT01313676 )

  • fluticasone furoate Vilanterol and lung function decline in patients with moderate chronic obstructive pulmonary disease and heightened cardiovascular risk
    American Journal of Respiratory and Critical Care Medicine, 2018
    Co-Authors: Peter M A Calverley, Julie A Anderson, Robert D Brook, Courtney Crim, Fernando J Martinez, Julie C Yates, David E Newby, Sally Kilbride, Natacha Gallot, Jørgen Vestbo
    Abstract:

    Rationale: Many patients with chronic obstructive pulmonary disease (COPD) have an accelerated loss of lung function. It is unclear whether drug treatment can modify this in patients with moderately severe disease.Objectives: In a prespecified analysis of the key secondary outcome in SUMMIT (Study to Understand Mortality and Morbidity), we investigated whether the inhaled corticosteroid fluticasone furoate (FF; 100 μg), the long-acting β-agonist Vilanterol (VI; 25 μg), or their combination (FF/VI) modified the rate of decline in FEV1 compared with placebo. We also investigated how baseline covariates affected this decline.Methods: Spirometry was measured every 12 weeks in this event-driven, randomized, placebo-controlled trial of 16,485 patients with moderate COPD and heightened cardiovascular risk. An average of seven spirometric assessments per subject among the 15,457 patients with at least one on-treatment measurement were used in the analysis of rate of FEV1 decline. All statistical comparisons are c...

  • Pneumonia risk with inhaled fluticasone furoate and Vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial
    Respiratory medicine, 2017
    Co-Authors: Courtney Crim, Julie A Anderson, Robert D Brook, Peter M A Calverley, Fernando J Martinez, Julie C Yates, David E Newby, Andrew P Holmes, Sally Kilbride, Bartolome R Celli
    Abstract:

    Abstract Rationale Pneumonia risk with inhaled corticosteroid use in chronic obstructive pulmonary disease (COPD) has not been thoroughly assessed in patients with moderate airflow limitation. Objectives To determine the incidence of pneumonia and risk factors in COPD patients with moderate airflow limitation who had, or were at high risk for cardiovascular disease. Methods In the Study to Understand Mortality and MorbidITy in COPD (SUMMIT), 16,590 subjects with moderate airflow limitation (50% ≤ FEV 1  ≤ 70% predicted) and heightened cardiovascular risk were randomized double-blind 1:1:1:1 to inhaled once-daily Vilanterol 25 μg (VI), fluticasone furoate 100 μg (FF), Vilanterol 25 μg combined with 100 μg fluticasone furoate (FF/VI), or matched placebo. In a pre-specified analysis, we assessed investigator-reported adverse pneumonia events, and independently-adjudicated fatal events. Measurements and main results The safety population comprised 16,568 subjects who actually received study medication. There were 1017 pneumonia events reported from 842 subjects. For placebo, FF, VI and FF/VI, reported pneumonia incidence was 5%, 5%, 4% and 6%, respectively. When adjusted for time on treatment, event rates were similar in the placebo, FF and FF/VI containing arms (3.84, 4.24 and 3.95/100 treatment years, respectively) but lower in the VI group (2.77/100 treatment years). Risk factors for pneumonia risk included: greater degree of airflow limitation (i.e. FEV 1 2 . Conclusions In contrast to previous studies in patients with severe disease, increased pneumonia risk with inhaled corticosteroid use was not evident in COPD subjects with moderate airflow limitation and heightened cardiovascular risk.

  • effect of fluticasone furoate and Vilanterol on exacerbations of chronic obstructive pulmonary disease in patients with moderate airflow obstruction
    American Journal of Respiratory and Critical Care Medicine, 2017
    Co-Authors: Jørgen Vestbo, Julie A Anderson, Robert D Brook, Bartolome R Celli, Courtney Crim, Fernando J Martinez, Mark T. Dransfield, Nicholas J Cowans, Sally Kilbride
    Abstract:

    Rationale: Inhaled corticosteroids have been shown to decrease exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Their effects in patients with milder airflow obstruction remain unclear.Objectives: This was an analysis of exacerbations in the SUMMIT (Study to Understand Mortality and Morbidity) study.Methods: In a double-blind, randomized controlled trial, once-daily inhaled placebo, fluticasone furoate (FF; 100 μg), Vilanterol (VI; 25 μg), or the combination of FF/VI was administered. The primary outcome was all-cause mortality. Exacerbations of COPD were an additional predefined endpoint. A total of 1,368 centers in 43 countries and 16,485 patients with moderate COPD and heightened cardiovascular risk were included in the study.Measurements and Main Results: Compared with placebo, FF/VI reduced the rate of moderate and/or severe exacerbations by 29% (95% confidence interval [CI], 22–35; P < 0.001) and the rate of hospitalized exacerbations by 27% (95% CI, 13...

  • a randomized trial of once daily fluticasone furoate Vilanterol or Vilanterol versus placebo to determine effects on arterial stiffness in copd
    International Journal of Chronic Obstructive Pulmonary Disease, 2017
    Co-Authors: Surya P Bhatt, Mark T. Dransfield, Catherine Scottwilson, Dawn Midwinter, John R Cockcroft, Jie Wangjairaj, David B Rubin, Courtney Crim
    Abstract:

    INTRODUCTION Chronic obstructive pulmonary disease (COPD) is associated with increased cardiovascular morbidity and mortality. Elevated arterial stiffness, measured by aortic pulse wave velocity (aPWV), is a cardiovascular risk surrogate and is potentially modifiable by inhaled corticosteroid/long-acting beta2-agonist combinations in patients with COPD. MATERIALS AND METHODS The effects of once-daily inhaled fluticasone furoate/Vilanterol (FF/VI) 100/25 µg, VI 25 µg, versus placebo on arterial stiffness in patients with COPD and baseline aPWV ≥11.0 m/s were investigated in a 24-week, multicenter, double-blind, randomized, stratified (by COPD exacerbation history), parallel-group, placebo-controlled trial. Eligible patients were ≥40 years old, with ≥10 pack-year smoking history, forced expiratory volume in 1 s (FEV1)/forced vital capacity ≤0.70, and post-bronchodilator FEV1 ≤70% of predicted. Patients with a major cardiovascular event in the previous 6 months/current severe heart failure/uncontrolled hypertension were excluded. Primary endpoint is change from baseline in aPWV after 24 weeks of treatment. Safety analyses included adverse events (AEs). RESULTS The intent-to-treat population included 430 patients: FF/VI (n=135), VI (n=154), and placebo (n=141). Patients were predominantly male (79%) and Asian or White (each 48%), with a mean age of 68.5 years (standard deviation [SD] =7.9), percentage predicted post-bronchodilator FEV1 50.1% (SD =13.3), and aPWV 13.26 m/s (SD =2.22) at screening. At 24 weeks, mean (standard error [SE]) changes from baseline in aPWV were -1.75 m/s (SE =0.26, FF/VI), -1.95 m/s (SE =0.24, VI), and -1.97 m/s (SE =0.28, placebo). AEs occurred in 57% (FF/VI), 51% (VI), and 41% (placebo) of patients. CONCLUSION No differences were observed in aPWV-adjusted mean change from baseline for FF/VI 100/25 µg, compared with placebo.

Elaine C Jones - One of the best experts on this subject based on the ideXlab platform.

  • informing the pathway of copd treatment impact trial single inhaler triple therapy fluticasone furoate umeclidinium Vilanterol versus fluticasone furoate Vilanterol and umeclidinium Vilanterol in patients with copd analysis of the western europe and north america regions
    Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, 2021
    Co-Authors: Arnaud Bourdin, Mark T. Dransfield, Gerard J Criner, David M G Halpin, Meilan K Han, Elaine C Jones, Peter Lange, Gilles Devouassoux, Ravi Kalhan, Sally Lettis
    Abstract:

    Background The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/Vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings. Methods IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed. Results Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe. Conclusion Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence. Clinical Trial Registration NCT02164513.

  • informing the pathway of copd treatment single inhaler triple therapy fluticasone furoate umeclidinium Vilanterol versus fluticasone furoate Vilanterol and umeclidinium Vilanterol in patients with copd analysis of the western europe and north america regions
    Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, 2020
    Co-Authors: Arnaud Bourdin, Mark T. Dransfield, Gerard J Criner, David M G Halpin, Meilan K Han, Elaine C Jones, Peter Lange, Gilles Devouassoux, Ravi Kalhan, Sally Lettis
    Abstract:

    Background The IMPACT trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/Vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings. Methods IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe (WE) and North America (NA) populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed. Results Overall, 10,355 patients were enrolled, 3164 from WE, 2639 from NA. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in WE (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and NA (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in WE, but not NA. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in NA but not WE. Conclusion Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in WE and NA; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.

  • the effect of inhaled corticosteroid withdrawal and baseline inhaled treatment on exacerbations in the impact study a randomized double blind multicenter clinical trial
    American Journal of Respiratory and Critical Care Medicine, 2020
    Co-Authors: Meilan K Han, Mark T. Dransfield, Sally Kilbride, Gerard J Criner, David M G Halpin, Elaine C Jones, Peter Lange, Sally Lettis, David A. Lipson
    Abstract:

    Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/Vilanterol (VI) significantly reduced exacerb...

  • single inhaler triple therapy fluticasone furoate umeclidinium Vilanterol versus fluticasone furoate Vilanterol and umeclidinium Vilanterol in patients with copd results on cardiovascular safety from the impact trial
    Respiratory Research, 2020
    Co-Authors: Nicola C Day, Mark T. Dransfield, Sally Kilbride, Gerard J Criner, David M G Halpin, Meilan K Han, Elaine C Jones, Subramanya Kumar, Morrys C Kaisermann, Peter Lange
    Abstract:

    This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/Vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy. IMPACT was a 52-week, randomized, double-blind, multicenter Phase III study comparing the efficacy and safety of FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC/VI 62.5/25 mcg in patients ≥40 years of age with symptomatic chronic obstructive pulmonary disease (COPD) and ≥1 moderate/severe exacerbation in the previous year. The inclusion criteria for the study were intentionally designed to permit the enrollment of patients with significant concurrent CV disease/risk. CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death. Baseline CV risk factors were similar across treatment groups. Overall, 68% of patients (n = 7012) had ≥1 CV risk factor and 40% (n = 4127) had ≥2. At baseline, 29% of patients reported a current/past cardiac disorder and 58% reported a current/past vascular disorder. The proportion of patients with on-treatment CVAESI was 11% for both FF/UMEC/VI and UMEC/VI, and 10% for FF/VI. There was no statistical difference for FF/UMEC/VI versus FF/VI or UMEC/VI in TTF CVAESI (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.85, 1.11; p = 0.711 and HR: 0.92, 95% CI: 0.78, 1.08; p = 0.317, respectively) nor TTF CVAESI leading to hospitalization/prolonged hospitalization or death (HR: 1.19, 95% CI: 0.93, 1.51; p = 0.167 and HR: 0.96, 95% CI: 0.72, 1.27; p = 0.760, respectively). On-treatment MACE occurred in ≤3% of patients across treatment groups, with similar prevalence and rates between treatments. In a symptomatic COPD population with a history of exacerbations and a high rate of CV disease/risk, the proportion of patients with CVAESI and MACE was 10–11% and 1–3%, respectively, across treatment arms, and the risk of CVAESI was low and similar across treatment arms. There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI. NCT02164513 (GSK study number CTT116855).

  • once daily single inhaler triple versus dual therapy in patients with copd
    The New England Journal of Medicine, 2018
    Co-Authors: David A. Lipson, Noushin Brealey, Mark T. Dransfield, Frank Barnhart, Gerard J Criner, David M G Halpin, Meilan K Han, Jean Brooks, Nicola C Day, Elaine C Jones
    Abstract:

    Abstract Background The benefits of triple therapy for chronic obstructive pulmonary disease (COPD) with an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA), as compared with dual therapy (either inhaled glucocorticoid–LABA or LAMA–LABA), are uncertain. Methods In this randomized trial involving 10,355 patients with COPD, we compared 52 weeks of a once-daily combination of fluticasone furoate (an inhaled glucocorticoid) at a dose of 100 μg, umeclidinium (a LAMA) at a dose of 62.5 μg, and Vilanterol (a LABA) at a dose of 25 μg (triple therapy) with fluticasone furoate–Vilanterol (at doses of 100 μg and 25 μg, respectively) and umeclidinium–Vilanterol (at doses of 62.5 μg and 25 μg, respectively). Each regimen was administered in a single Ellipta inhaler. The primary outcome was the annual rate of moderate or severe COPD exacerbations during treatment. Results The rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, as...

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