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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
#1
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 1, 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
#2
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
#3
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
#4
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...
October 7, 2017: 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
#5
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...
September 29, 2017: 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
#6
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
#7
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
#8
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
#9
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 Ellipta(TM) dry powder inhaler (DPI) has also been available as a new device with high levels of satisfaction and preference...
September 19, 2017: 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
#10
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...
September 10, 2017: Lancet
https://www.readbyqxmd.com/read/28891349/next-generation-beta-adrenoreceptor-agonists-for-the-treatment-of-asthma
#11
Ernesto Crisafulli, Annalisa Frizzelli, Alberto Fantin, Alessandra Manco, Angelo Mangia, Giovanna Pisi, Valentina Fainardi, Veronica Alfieri, Marina Aiello, Giuseppina Bertorelli, Alfredo Chetta
A fixed-dose inhalation of a long-acting β-agonist (LABA) and inhaled corticosteroids (ICS) is commonly recommended for moderate to severe asthmatic patients not adequately controlled by an ICS only. In order to improve the patients' adherence and the control of disease there is a noteworthy interest for the next generation inhaled β adrenoreceptor agonists maintaining an over 24 hours bronchodilatation and used once-daily (ultra-LABAs). This review focuses on the currently available evidences on the clinical role of any single ultra-LABAs in the treatment of asthmatic patients...
October 2017: Expert Opinion on Pharmacotherapy
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
#12
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
#13
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
https://www.readbyqxmd.com/read/28737971/fluticasone-furoate-vilanterol-and-lung-function-decline-in-patients-with-moderate-copd-and-heightened-cardiovascular-risk
#14
Peter M A Calverley, Julie A Anderson, Robert D Brook, Courtney Crim, Natacha Gallot, Sally Kilbride, Fernando Martinez, Julie Yates, David E Newby, Jørgen Vestbo, Robert Wise, Bartolome R Celli
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 moderately severe disease. OBJECTIVES: In a pre-specified analysis of the key secondary outcome in the Study to Understand Mortality and MorbidITy (SUMMIT), we investigated whether the inhaled corticosteroid fluticasone furoate 100 μg (FF), the long-acting beta-agonist vilanterol 25 µg (VI) or the combination (FF/VI) modified the rate of decline in FEV1 compared with placebo...
July 24, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28721035/intracellular-interactions-of-umeclidinium-and-vilanterol-in-human-airway-smooth-muscle
#15
Nooreen Shaikh, Malcolm Johnson, David A Hall, Kian Fan Chung, John H Riley, Sally Worsley, Pankaj K Bhavsar
BACKGROUND: Intracellular mechanisms of action of umeclidinium (UMEC), a long-acting muscarinic receptor antagonist, and vilanterol (VI), a long-acting β2-adrenoceptor (β2R) agonist, were investigated in target cells: human airway smooth-muscle cells (ASMCs). MATERIALS AND METHODS: ASMCs from tracheas of healthy lung-transplant donors were treated with VI, UMEC, UMEC and VI combined, or control compounds (salmeterol, propranolol, ICI 118.551, or methacholine [MCh])...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28716723/pharmacological-characterization-of-the-interaction-between-umeclidinium-and-vilanterol-in-human-bronchi
#16
Luigino Calzetta, Paola Rogliani, Francesco Facciolo, Erino Rendina, Mario Cazzola, Maria Gabriella Matera
The long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) fixed dose combination (FDC) therapy represents the cornerstone for the treatment of chronic obstructive pulmonary disease (COPD). Nevertheless, conflicting clinical findings still exist on the real benefit of the LABA/LAMA FDCs. Therefore, we investigated whether combining the LABA vilanterol with the LAMA umeclidinium may induce synergistic bronchorelaxant effect in isolated airways. The effect of umeclidinium and vilanterol, administered alone, in combination at the ratio of concentrations reproducing the doses delivered by Anoro(®) Ellipta(®) (55:22), or at isoeffective low concentrations, was investigated on the cholinergic contractile tone induced by the parasympathetic activation of human isolated airways...
October 5, 2017: European Journal of Pharmacology
https://www.readbyqxmd.com/read/28685913/could-phase-3-medicine-trials-be-tagged-as-pragmatic-a-case-study-the-salford-copd-trial
#17
Rafael Dal-Ré
Randomized clinical trials (RCTs) can be classified as explanatory or pragmatic. Currently, explanatory and pragmatic are considered to be the extremes of a continuum: Many trials have some features of both explanatory and pragmatic RCTs. The Salford Chronic Obstructive Respiratory Disease (COPD) trial was an open-label phase 3 RCT assessing an experimental product (fluticasone furoate-vilanterol) vs usual care. The Salford investigators labelled it as "the world's first phase 3 pragmatic RCT" in COPD patients...
July 7, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28603412/in-vitro-dose-comparison-of-respimat-%C3%A2-inhaler-with-dry-powder-inhalers-for-copd-maintenance-therapy
#18
Anna-Maria Ciciliani, Peter Langguth, Herbert Wachtel
BACKGROUND: Combining in vitro mouth-throat deposition measurements, cascade impactor data and computational fluid dynamics (CFD) simulations, four different inhalers were compared which are indicated for chronic obstructive pulmonary disease (COPD) treatment. METHODS: The Respimat inhaler, the Breezhaler, the Genuair, and the Ellipta were coupled to the idealized Alberta throat model. The modeled dose to the lung (mDTL) was collected downstream of the Alberta throat model using either a filter or a next generation impactor (NGI)...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28491268/umeclidinium-in-chronic-obstructive-pulmonary-disease-latest-evidence-and-place-in-therapy
#19
REVIEW
Kesavan Suresh Babu, Jaymin Bhagwanji Morjaria
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity, mortality and health care expenditure throughout the world. COPD guidelines recommend the use of long-acting muscarinic antagonist (LAMA) either alone or in combination with a long-acting β2 agonist (LABA). For over 10 years, tiotropium was the only LAMA that was used in the management of COPD. Over the past few years, various new drugs have been identified that act on the muscarinic receptors and β2 receptors. Umeclidinium (Umec) is a new LAMA currently approved for use in patients with COPD either as monotherapy or in combination with vilanterol (Vil)...
April 2017: Therapeutic Advances in Chronic Disease
https://www.readbyqxmd.com/read/28427545/corrigendum-to-efficacy-and-safety-comparison-fluticasone-furoate-and-fluticasone-propionate-after-step-down-from-fluticasone-furoate-vilanterol-in-japanese-patients-with-well-controlled-asthma-a-randomized-trial-respir-med-120-november-2016-78-86
#20
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