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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/29629403/effectiveness-of-umeclidinium-vilanterol-for-protocolized-management-of-chronic-obstructive-pulmonary-disease-exacerbation-in-hospitalized-patients-a-sequential-period-analysis
#5
Todd W Chapin, Michael A Mann, Gary L Brown, Traci L Leitheiser, Becky Anderson, David D Leedahl
Background: Bronchodilator therapy is a foundation of chronic obstructive pulmonary disease (COPD) exacerbation treatment. Although international guidelines recommend short-acting formulations given multiple times per day, long-acting formulations have not been adequately evaluated. The objective of our study was to determine the effectiveness of umeclidinium-vilanterol (UME/VIL), long-acting beta2-agonist/long-acting muscarinic antagonist (LABA/LAMA) as a once-daily alternative for treating COPD exacerbations in hospitalized patients...
January 24, 2018: Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation
https://www.readbyqxmd.com/read/29583021/copd-2017-a-year-in-review
#6
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
#7
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
#8
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
#9
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/29386889/relationship-between-exercise-endurance-and-static-hyperinflation-in-a-post-hoc-analysis-of-two-clinical-trials-in-patients-with-copd
#10
Sally Singh, François Maltais, Lee Tombs, William A Fahy, Mitra Vahdati-Bolouri, Nicholas Locantore, John H Riley
Background: Lung hyperinflation and exercise intolerance are hallmarks of chronic obstructive pulmonary disease (COPD). However, their relationship remains uncertain. A combined analysis of two placebo-controlled, randomized studies examined the effects of the long-acting muscarinic antagonist umeclidinium (UMEC) and long-acting β2 -agonist vilanterol (VI) separately and in combination on static hyperinflation, exercise endurance time (EET), and their relationship in patients with COPD...
2018: International Journal of Chronic Obstructive Pulmonary Disease
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
#11
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
#12
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/29322050/effects-of-umeclidinium-vilanterol-on-exercise-endurance-in-copd-a-randomised-study
#13
John H Riley, Chris J Kalberg, Alison Donald, David A Lipson, Muhammad Shoaib, Lee Tombs
This multicentre, randomised, double-blind, placebo-controlled, two-period crossover study assessed the effect of umeclidinium/vilanterol (UMEC/VI) on exercise capacity in patients with chronic obstructive pulmonary disease (COPD) using the endurance shuttle walk test (ESWT). Patients were randomised 1:1 to one of two treatment sequences: 1) UMEC/VI 62.5/25 µg followed by placebo or 2) placebo followed by UMEC/VI 62.5/25 µg. Each treatment was taken once daily for 12 weeks. The primary end-point was 3-h post-dose exercise endurance time (EET) at week 12...
January 2018: ERJ Open Research
https://www.readbyqxmd.com/read/29313286/once-daily-triple-therapy-in-patients-with-copd-patient-reported-symptoms-and-quality-of-life
#14
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/29183838/abediterol-las100977-an-inhaled-long-acting-%C3%AE-2-adrenoceptor-agonist-has-a-fast-association-rate-and-long-residence-time-at-receptor
#15
Israel Ramos, Mònica Aparici, Maria Letosa, Carlos Puig, Amadeu Gavaldà, Josep Maria Huerta, Sonia Espinosa, Dolors Vilella, Montserrat Miralpeix
This study describes the association rate and residence time of abediterol, a novel long-acting β2 -adrenoceptor agonist (LABA) in Phase II development for treatment of asthma and COPD, in comparison with indacaterol, olodaterol, vilanterol and salmeterol, for both human β1 - and β2 -adrenoceptors. Abediterol association and dissociation rates were monitored directly by using its tritiated form. Moreover, association was determined indirectly using experimental Ki and koff obtained from assays performed with unlabelled compound...
January 15, 2018: European Journal of Pharmacology
https://www.readbyqxmd.com/read/29094315/comparative-efficacy-of-once-daily-umeclidinium-vilanterol-and-tiotropium-olodaterol-therapy-in-symptomatic-chronic-obstructive-pulmonary-disease-a-randomized-study
#16
Gregory J Feldman, Ana R Sousa, David A Lipson, Lee Tombs, Neil Barnes, John H Riley, Sadhana Patel, Ian Naya, Chris Compton, Bernardino Alcázar Navarrete
INTRODUCTION: We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2 -agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD. METHODS: This was a randomized, two-period crossover open-label study in symptomatic patients with COPD [age 40 years or older, postbronchodilator forced expiratory volume in 1 s (FEV1 ) of 70% or less and 50% or more of predicted normal values, and modified Medical Research Council Dyspnoea Scale score of 2 or greater] not receiving inhaled corticosteroid therapy...
November 2017: 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
#17
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/28993871/dual-bronchodilation-with-indacaterol-maleate-glycopyrronium-bromide-compared-with-umeclidinium-bromide-vilanterol-in-patients-with-moderate-to-severe-copd-results-from-two-randomized-controlled-cross-over-studies
#18
Edward Kerwin, Gary T Ferguson, Shahin Sanjar, Thomas Goodin, Anthony Yadao, Robert Fogel, Samopriyo Maitra, Biswajit Sen, Tim Ayers, Donald Banerji
PURPOSE: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI). METHODS: Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62...
December 2017: Lung
https://www.readbyqxmd.com/read/28993264/sensory-mechanical-effects-of-a-dual-bronchodilator-and-its-anticholinergic-component-in-copd
#19
Denis E O'Donnell, Amany F Elbehairy, Azmy Faisal, J Alberto Neder, Katherine A Webb
This randomized, double-blind, crossover study examined the physiological rationale for using a dual long-acting bronchodilator (umeclidinium/vilanterol (UME/VIL)) versus its muscarinic-antagonist component (UME) as treatment for dyspnea and exercise intolerance in moderate COPD. After each 4-week treatment period, subjects performed pulmonary function and symptom-limited constant-work rate cycling tests with diaphragm electromyogram (EMGdi), esophageal (Pes), gastric (Pga) and transdiaphragmatic (Pdi) pressure measurements...
January 2018: Respiratory Physiology & Neurobiology
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
#20
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
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