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Fluticasone furoate-vilanterol

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https://www.readbyqxmd.com/read/29033625/the-salford-lung-study-a-pioneering-comparative-effectiveness-approach-to-copd-and-asthma-in-clinical-trials
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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/28875459/once-daily-triple-therapy-in-patients-with-advanced-copd-healthcare-resource-utilization-data-and-associated-costs-from-the-fulfil-trial
#8
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
#9
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
#10
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/28685913/could-phase-3-medicine-trials-be-tagged-as-pragmatic-a-case-study-the-salford-copd-trial
#11
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/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
#12
https://www.readbyqxmd.com/read/28416587/cardiovascular-outcomes-with-an-inhaled-beta2-agonist-corticosteroid-in-patients-with-copd-at-high-cardiovascular-risk
#13
RANDOMIZED CONTROLLED TRIAL
Robert D Brook, Julie A Anderson, Peter Ma Calverley, Bartolome R Celli, Courtney Crim, Martin A Denvir, Sheldon Magder, Fernando J Martinez, Sanjay Rajagopalan, Jørgen Vestbo, Julie Yates, David E Newby
OBJECTIVES: Cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) often coexist. We assessed the effect of inhaled COPD treatments on CVD outcomes and safety in patients with COPD and at heightened CVD risk. METHODS: The SUMMIT (Study to Understand Mortality and MorbidITy) was a multicentre, randomised, double-blind, placebo-controlled, event-driven trial in 16 485 patients with moderate COPD who had or were at high risk of CVD. Here, we assessed the prespecified secondary endpoint of time to first on-treatment composite CVD event (CVD death, myocardial infarction, stroke, unstable angina or transient ischaemic attack (TIA)) by Cox regression and by clinician-reported CVD adverse events across the four groups: once-daily inhaled placebo (n=4111), long-acting beta2-agonist (vilanterol (VI) 25 µg; n=4118), corticosteroid (fluticasone furoate (FF) 100 µg; n=4135) and combination therapy (FF/VI; n=4121)...
October 2017: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/28375647/fulfil-trial-once-daily-triple-therapy-for-patients-with-chronic-obstructive-pulmonary-disease
#14
RANDOMIZED CONTROLLED TRIAL
David A Lipson, Helen Barnacle, Ruby Birk, Noushin Brealey, Nicholas Locantore, David A Lomas, Andrea Ludwig-Sengpiel, Rajat Mohindra, Maggie Tabberer, Chang-Qing Zhu, Steven J Pascoe
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...
August 15, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28176907/a-randomized-trial-of-once-daily-fluticasone-furoate-vilanterol-or-vilanterol-versus-placebo-to-determine-effects-on-arterial-stiffness-in-copd
#15
RANDOMIZED CONTROLLED TRIAL
Surya P Bhatt, Mark T Dransfield, John R Cockcroft, Jie Wang-Jairaj, Dawn A Midwinter, David B Rubin, Catherine A Scott-Wilson, Courtney Crim
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...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28137501/a-randomised-phase-iii-trial-of-once-daily-fluticasone-furoate-vilanterol-100-25%C3%A2-%C3%AE-g-versus-once-daily-vilanterol-25%C3%A2-%C3%AE-g-to-evaluate-the-contribution-on-lung-function-of-fluticasone-furoate-in-the-combination-in-patients-with-copd
#16
Thomas M Siler, Atsushi Nagai, Catherine A Scott-Wilson, Dawn A Midwinter, Courtney Crim
BACKGROUND: The contribution of fluticasone furoate (FF) on lung function in the FF/vilanterol (VI) 100/25 μg combination has been demonstrated numerically, but not statistically. METHODS: This multicentre, randomised, double-blind, controlled trial (GlaxoSmithKline study number 200820; clinicaltrials.gov NCT02105974) enrolled ≥40-year-old patients with chronic obstructive pulmonary disease (COPD), a ≥10-pack-year smoking history, a post-bronchodilator forced expiratory volume in 1 s (FEV1) 30-70% of the predicted value, a FEV1/forced vital capacity ratio of ≤0...
February 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28115838/spotlight-on-fluticasone-furoate-umeclidinium-vilanterol-in-copd-design-development-and-potential-place-in-therapy
#17
REVIEW
Chitra Lal, Charlie Strange
COPD is characterized by persistent airflow obstruction caused by exposure to irritants including cigarette smoke, dust, and fumes. According to the latest GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines, a combination of inhaled corticosteroids, long-acting β2 agonists, and long-acting muscarinic receptor antagonists can be used for group D COPD patients who are at high risk for exacerbations. Umeclidinium/fluticasone furoate/vilanterol is one such triple-combination therapy currently under development with some completed and several ongoing clinical trials...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28029916/effectiveness-of-fluticasone-furoate-vilanterol-in-copd
#18
LETTER
Samy Suissa
No abstract text is available yet for this article.
December 29, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/28029915/effectiveness-of-fluticasone-furoate-vilanterol-in-copd
#19
LETTER
Jørgen Vestbo
No abstract text is available yet for this article.
December 29, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/28008228/spotlight-on-fluticasone-furoate-vilanterol-trifenatate-for-the-once-daily-treatment-of-asthma-design-development-and-place-in-therapy
#20
REVIEW
Timothy E Albertson, Samuel W Bullick, Michael Schivo, Mark E Sutter
The use of inhaled corticosteroids (ICSs) plays a key role in the treatment of asthmatic patients, and international guidelines have designated ICSs as an early maintenance therapy in controlling asthma symptoms. When asthmatic patients remain symptomatic on ICSs, one common option is to add a long-acting beta2 agonist (LABA) to the maintenance treatment. Fixed combination inhalers that contain both an ICS and a LABA have been popular for both chronic obstructive pulmonary disease (COPD) and asthma. Historically, these inhalers have been dosed twice daily...
2016: Drug Design, Development and Therapy
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