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Fluticasone furoate-vilanterol

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https://www.readbyqxmd.com/read/29762864/population-pharmacokinetic-analysis-of-fluticasone-furoate-umeclidinium-vilanterol-via-a-single-inhaler-in-patients-with-copd
#1
Rashmi Mehta, Eleni Pefani, Misba Beerahee, Noushin Brealey, Helen Barnacle, Ruby Birk, Chang-Qing Zhu, David A Lipson
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...
May 15, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29750142/single-inhaler-triple-therapy-in-symptomatic-copd-patients-fulfil-subgroup-analyses
#2
David M G Halpin, Ruby Birk, Noushin Brealey, Gerard J Criner, Mark T Dransfield, Emma Hilton, David A Lomas, Chang-Qing Zhu, David A Lipson
Triple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β2 -agonist (LABA) therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD) and at risk of exacerbations. However, the benefits versus side-effects of triple inhaled therapy for COPD, based on distinct patient clinical profiles, are unclear. FULFIL, a phase III, randomised, double-blind study, compared 24 weeks of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62...
April 2018: ERJ Open Research
https://www.readbyqxmd.com/read/29668352/once-daily-single-inhaler-triple-versus-dual-therapy-in-patients-with-copd
#3
David A Lipson, Frank Barnhart, Noushin Brealey, Jean Brooks, Gerard J Criner, Nicola C Day, Mark T Dransfield, David M G Halpin, MeiLan K Han, C Elaine Jones, Sally Kilbride, Peter Lange, David A Lomas, Fernando J Martinez, Dave Singh, Maggie Tabberer, Robert A Wise, Steven J Pascoe
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...
April 18, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29650761/once-daily-triple-therapy-inhaler-for-copd
#4
(no author information available yet)
▼Trelegy Ellipta (GSK) is a dry powder inhaler containing fluticasone furoate (inhaled corticosteroid [ICS]), vilanterol trifenatate (long-acting beta2 agonist [LABA]) and umeclidinium bromide (long-acting muscarinic antagonist [LAMA]).1 It is licensed for once-daily use as maintenance treatment for adults with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS and a LABA. Here, we consider the evidence for this combination product and discuss how it fits with current management strategies...
April 2018: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/29583021/copd-2017-a-year-in-review
#5
Ernesto Crisafulli, Antoni Torres
In this review, we focused on original manuscripts published in the 2017 that provided additional information on the clinical and therapeutic features of the chronic obstructive pulmonary disease (COPD). We have chosen eight of these studies, collected in four topics concerning the pharmacological treatment (tiotropium) of mild-moderate patients, the pharmacological (fluticasone furoate/vilanterol/umeclidinium) and non-pharmacological treatment (non-invasive mechanical ventilation) of severe patients, the etiology of acute exacerbation of COPD involving seasonal airway pathogens and the role of eosinophils with particular interest to the monoclonal antibody directed against interleukin-5 (mepolizumab)...
March 27, 2018: COPD
https://www.readbyqxmd.com/read/29537340/single-inhaler-triple-therapy-utilizing-the-once-daily-combination-of-fluticasone-furoate-umeclidinium-and-vilanterol-in-the-management-of-copd-the-current-evidence-base-and-future-prospects
#6
Mario Malerba, Matteo Nardin, Giuseppe Santini, Nadia Mores, Alessandro Radaeli, Paolo Montuschi
Maintenance pharmacological treatment for stable chronic obstructive pulmonary disease (COPD) is based on inhaled drugs, including long-acting muscarinic receptor antagonists (LAMA), long-acting β2 -adrenoceptor agonists (LABA) and inhaled corticosteroids (ICS). Inhaled pharmacological treatment can improve patients' daily symptoms and reduce decline of pulmonary function and acute exacerbation rate. Treatment with all three inhaled drug classes is reserved for selected, more severe, patients with COPD when symptoms are not sufficiently controlled by dual LABA/LAMA therapy and exacerbations are frequent...
January 2018: Therapeutic Advances in Respiratory Disease
https://www.readbyqxmd.com/read/29512364/glucocorticoid-receptor-nuclear-translocation-in-cd4-t-cells-from-severe-and-moderate-asthmatic-patients-treated-with-fluticasone-vilanterol
#7
Zahra Alizadeh, Marzieh Mazinani, Esmaeil Mortaz, Mohammad Reza Fazlollahi, Ian Adcock, Mostafa Moein
Different phenotypes of asthma from mild to severe are categorized based on diverse clinical features. A guideline for the recognition and treatment of asthma has been provided by Global Initiative for Asthma (GINA). To control symptoms and prevent asthma exacerbation in most patients combinational therapy with inhaled corticosteroids (ICS) and a long acting B2-adrenreceptor agonist (LABA) are recommended. Understanding asthma phenotypes would be helpful to improve asthma diagnosis and treatment. The aim of this study was to verify glucocorticoid receptor glcococorticoid receptor (GR) nuclear translocation in CD4 T cells treated with fluticasone furoate (FF), vilanterol (V) and FF/V combination in severe asthmatic patients compare to patients with moderate asthma and healthy controls using Immunocytochemistry (ICC)...
February 2018: Iranian Journal of Allergy, Asthma, and Immunology
https://www.readbyqxmd.com/read/29406772/%C3%AE-blocker-therapy-and-clinical-outcomes-in-patients-with-moderate-chronic-obstructive-pulmonary-disease-and-heightened-cardiovascular-risk-an-observational-substudy-of-summit
#8
Mark T Dransfield, David A McAllister, Julie A Anderson, Robert D Brook, Peter M A Calverley, Bartolome R Celli, Courtney Crim, Natacha Gallot, Fernando J Martinez, Paul D Scanlon, Julie Yates, Jørgen Vestbo, David E Newby
RATIONALE: Cardiovascular disease is a common comorbidity in patients with chronic obstructive pulmonary disease. Although β-blockers can be used safely in patients with chronic obstructive pulmonary disease, concerns remain regarding safety and efficacy interactions in patients using concomitant inhaled long-acting β-agonists. OBJECTIVES: To compare the differential effects of long-acting β-agonist or inhaled corticosteroid use on clinical outcomes in patients with heightened cardiovascular risk treated and not treated with β-blockers...
May 2018: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/29386888/predictors-of-pneumonia-on-routine-chest-radiographs-in-patients-with-copd-a-post-hoc-analysis-of-two-1-year-randomized-controlled-trials
#9
David B Rubin, Harris A Ahmad, Michael O'Neal, Sophie Bennett, Sally Lettis, Dmitry V Galkin, Courtney Crim
Background: Patients with COPD are at risk for life-threatening pneumonia. Although anatomical abnormalities in the thorax may predispose to pneumonia, those abnormalities identified on routine chest X-rays (CXRs) in patients with COPD have not been studied to better understand pneumonia risk. Methods: We conducted a post hoc exploratory analysis of data from two replicate year-long clinical trials assessing the impact of fluticasone furoate-vilanterol versus vilanterol alone on COPD exacerbations (GSK studies: HZC102871/NCT01009463 and HZC102970/NCT01017952)...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29370819/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
#10
Peter R Bremner, Ruby Birk, Noushin Brealey, Afisi S Ismaila, Chang-Qing Zhu, David A Lipson
BACKGROUND: 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. METHODS: 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...
January 25, 2018: Respiratory Research
https://www.readbyqxmd.com/read/29313286/once-daily-triple-therapy-in-patients-with-copd-patient-reported-symptoms-and-quality-of-life
#11
Maggie Tabberer, David A Lomas, Ruby Birk, Noushin Brealey, Chang-Qing Zhu, Steve Pascoe, Nicholas Locantore, David A Lipson
INTRODUCTION: Directly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported. METHODS: FULFIL was a phase III, 24-week, randomized, double-blind, double-dummy, multicenter study comparing once-daily single inhaler triple therapy [fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)] 100 µg/62...
January 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29033625/the-salford-lung-study-a-pioneering-comparative-effectiveness-approach-to-copd-and-asthma-in-clinical-trials
#12
REVIEW
Timothy E Albertson, Susan Murin, Mark E Sutter, James A Chenoweth
The Salford Lung Study (SLS) of patients with asthma and chronic obstructive pulmonary disease (COPD) is a practical, community-based, randomized, open-label pragmatic study on the efficacy and safety of the once-daily dry powder inhaler that combines the inhaled corticosteroid fluticasone furoate (FF) with the long-acting beta2 agonist vilanterol (VI). The asthma component of the SLS is not yet reported but the COPD component, done over a 12-month period, found a statistically significant 8.4% reduction in COPD exacerbations when compared to usual care...
2017: Pragmatic and Observational Research
https://www.readbyqxmd.com/read/28961020/once-daily-fluticasone-furoate-vilanterol-versus-twice-daily-fluticasone-propionate-salmeterol-in-patients-with-asthma-well-controlled-on-ics-laba
#13
David Bernstein, Leslie Andersen, Richard Forth, Loretta Jacques, Louisa Yates
OBJECTIVE: We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting β2 agonist (ICS/LABA). METHODS: This was a randomized, double-blind, double-dummy, parallel-group, 24-week study (NCT02301975/GSK study 201378). Patients whose asthma met study-defined criteria for control were randomized 1:1:1 to receive FF/VI, FP/SAL or twice-daily FP 250 µg for 24 weeks...
April 13, 2018: Journal of Asthma: Official Journal of the Association for the Care of Asthma
https://www.readbyqxmd.com/read/28956463/fluticasone-furoate-and-vilanterol-for-the-treatment-of-chronic-obstructive-pulmonary-disease
#14
Gaetano Caramori, Paolo Ruggeri, Paolo Casolari, Kian Fan Chung, Giuseppe Girbino, Ian M Adcock
Current national and international guidelines for the management of patients with stable chronic obstructive pulmonary disease (COPD) recommend the use of inhaled long-acting bronchodilators, inhaled glucocorticoids and their combinations for maintenance treatment of moderate to severe stable COPD. Areas covered: The role of fluticasone furoate (FF) and vilanterol (VI) once daily combination therapy for the regular treatment of patients with stable COPD is discussed in this review. Expert commentary: The regular treatment of moderate to severe stable COPD with once daily FF/VI combination therapy is effective, as seen in in several large placebo-controlled clinical trials involving many thousands of patients...
December 2017: Expert Review of Respiratory Medicine
https://www.readbyqxmd.com/read/28947039/pneumonia-risk-with-inhaled-fluticasone-furoate-and-vilanterol-in-copd-patients-with-moderate-airflow-limitation-the-summit-trial
#15
Courtney Crim, Peter M A Calverley, Julie A Anderson, Andrew P Holmes, Sally Kilbride, Fernando J Martinez, Robert D Brook, David E Newby, Julie C Yates, Bartolomé R Celli, Jørgen Vestbo
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% ≤ FEV1  ≤ 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...
October 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28947022/the-effect-of-umeclidinium-on-lung-function-and-symptoms-in-patients-with-fixed-airflow-obstruction-and-reversibility-to-salbutamol-a-randomised-3-phase-study
#16
Laurie Lee, Edward Kerwin, Kathryn Collison, Linda Nelsen, Wei Wu, Shuying Yang, Steven Pascoe
INTRODUCTION: The long-acting muscarinic antagonist, umeclidinium (UMEC), combined with the inhaled corticosteroid, fluticasone furoate (FF), improves lung function in symptomatic patients with asthma. We assessed FF/UMEC in patients with a primary diagnosis of asthma or chronic obstructive pulmonary disease (COPD), but physiological characteristics of both (fixed airflow obstruction and reversibility to salbutamol). METHODS: This double-blind, parallel-arm, 3-phase study randomised 338 patients (1:1:1:1:2:2) to FF 100 mcg alone or combined with UMEC (15...
October 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28926855/a-comparison-of-the-efficacy-of-once-daily-fluticasone-furoate-vilanterole-with-twice-daily-fluticasone-propionate-salmeterol-in-elderly-asthmatics
#17
Yoshihisa Ishiura, Masaki Fujimura, Yasutaka Shiba, Noriyuki Ohkura, Johsuke Hara, Miki Abo, Kazuo Kasahara
BACKGROUND: Asthma in the elderly population has been focused because it affects quality of life and results in a higher hospitalization rate and mortality. Fluticasone furoate (FF)/vilanterole (VI) is a novel inhaled corticosteroids (ICS)/long-acting β2 agonist (LABA) combination being developed for once-daily administration for asthma with greater anti-inflammatory activity and longer duration of bronchidilation. The ElliptaTM dry powder inhaler (DPI) has also been available as a new device with high levels of satisfaction and preference...
January 2018: Drug Research
https://www.readbyqxmd.com/read/28903864/effectiveness-of-fluticasone-furoate-plus-vilanterol-on-asthma-control-in-clinical-practice-an-open-label-parallel-group-randomised-controlled-trial
#18
Ashley Woodcock, Jørgen Vestbo, Nawar Diar Bakerly, John New, J Martin Gibson, Sheila McCorkindale, Rupert Jones, Susan Collier, James Lay-Flurrie, Lucy Frith, Loretta Jacques, Joanne L Fletcher, Catherine Harvey, Henrik Svedsater, David Leather
BACKGROUND: Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice. METHODS: We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months...
November 18, 2017: Lancet
https://www.readbyqxmd.com/read/28875459/once-daily-triple-therapy-in-patients-with-advanced-copd-healthcare-resource-utilization-data-and-associated-costs-from-the-fulfil-trial
#19
Afisi S Ismaila, Ruby Birk, Dhvani Shah, Shiyuan Zhang, Noushin Brealey, Nancy A Risebrough, Maggie Tabberer, Chang-Qing Zhu, David A Lipson
INTRODUCTION: Chronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62.5 µg/25 µg or twice-daily dual inhaled corticosteroid/long-acting beta agonist therapy (budesonide/formoterol) 400 µg/12 µg...
September 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28783413/fluticasone-furoate-vilanterol-once-daily-improves-night-time-awakenings-in-asthma-patients-with-night-symptoms-post-hoc-analyses-of-three-randomized-controlled-trials
#20
Edward Kerwin, Neil Barnes, Michael Gibbs, David Leather, Richard Forth, Loretta Jacques, Louisa J Yates
Symptoms, including night-time awakenings, affect the quality of life of people with asthma. Fluticasone furoate/vilanterol (FF/VI) reduces exacerbations, improves lung function, and rescue-free and symptom-free 24-hour periods in patients with asthma. These post-hoc analyses compared daytime and night-time symptoms in patients with asthma who received FF/VI, versus FF, fluticasone propionate (FP) or placebo. Daytime and night-time symptoms were collected via electronic daily diary cards in three Phase III randomized studies of once-daily FF/VI in patients with uncontrolled asthma on inhaled corticosteroids (ICS) ±long-acting beta2-agonists (LABA) (n = 609/1039/586)...
August 7, 2017: Journal of Asthma: Official Journal of the Association for the Care of Asthma
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