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Fernando J Martinez, Jørgen Vestbo, Julie A Anderson, Robert D Brook, Bartolome R Celli, Nicholas J Cowans, Courtney Crim, Mark Dransfield, Sally Kilbride, Julie Yates, David E Newby, Dennis Niewoehner, Peter Ma Calverley
BACKGROUND: Inhaled corticosteroids have been shown to decrease exacerbations in COPD patients with moderate to severe COPD. Their effect in patients with milder airflow obstruction remains unclear. OBJECTIVE: This was an analysis of exacerbations in the Study to Understand Mortality and MorbidITy (SUMMIT) study. DESIGN: In a double-blind randomized controlled trial, once daily inhaled placebo, fluticasone furoate (FF, 100 μg), vilanterol (VI, 25 μg) or the combination (FF/VI) was administered...
October 21, 2016: American Journal of Respiratory and Critical Care Medicine
Irene Braithwaite, Mathew Williams, Sharon Power, Janine Pilcher, Mark Weatherall, Amanda Baines, Jackie Moynihan, Rodger Kempsford, Richard Beasley
BACKGROUND: Fluticasone furoate (FF)/vilanterol (VI) is a once-daily maintenance treatment for asthma and chronic obstructive pulmonary disease. The duration of bronchodilation beyond 24 h has not been determined previously. METHODS: Adults aged 18-65 (n = 32), with asthma and reversibility to salbutamol (≥15% and ≥200 mL increase in forced expiratory volume in 1 s [FEV1]) participated in a double-blind, placebo-controlled, crossover study. Patients were admitted to a clinical trials unit for 72 h, and inhaled, in random order, placebo or FF/VI 100/25 mcg via ELLIPTA dry powder inhaler on two occasions 7-14 days apart...
October 2016: Respiratory Medicine
Vicky Chang, Emma L Gray, Paul S Thomas
INTRODUCTION: Fluticasone furoate (FF) is a novel inhaled corticosteroid (ICS). Vilanterol trifenate (VI) is a new inhaled, selective, long - acting β2 adrenergic agonist (LABA). It is now also marketed as a novel once daily combined ICS/LABA indicated for treatment of moderate and severe asthma. AREAS COVERED: FF has a highly specific, fast association and slow dissociation from the glucocorticoid receptor, with a 24 hr duration of action. This, combined with a slow transport out of respiratory cells, creates a long tissue retention period...
October 2016: Expert Review of Respiratory Medicine
Jørgen Vestbo, David Leather, Nawar Diar Bakerly, John New, J Martin Gibson, Sheila McCorkindale, Susan Collier, Jodie Crawford, Lucy Frith, Catherine Harvey, Henrik Svedsater, Ashley Woodcock
Background Evidence for the management of chronic obstructive pulmonary disease (COPD) comes from closely monitored efficacy trials involving groups of patients who were selected on the basis of restricted entry criteria. There is a need for randomized trials to be conducted in conditions that are closer to usual clinical practice. Methods In a controlled effectiveness trial conducted in 75 general practices, we randomly assigned 2799 patients with COPD to a once-daily inhaled combination of fluticasone furoate at a dose of 100 μg and vilanterol at a dose of 25 μg (the fluticasone furoate-vilanterol group) or to usual care (the usual-care group)...
September 29, 2016: New England Journal of Medicine
Kerry Dwan, Stephen J Milan, Lynne Bax, Nicola Walters, Colin Powell
BACKGROUND: Vilanterol (VI) is a long-acting beta2-agonist (LABA) that binds to the beta2-adrenoceptor on the airway smooth muscle, producing bronchodilation. LABA therapy, which is well established in adults as part of the British Thoracic Society (BTS) Guidelines for the Management of Asthma, leads to improvement in symptoms and lung function and reduction in exacerbations. At present, the commonly used LABAs licensed for use in asthma management (formoterol and salmeterol) require twice-daily administration, whereas VI is a once-daily therapy...
September 1, 2016: Cochrane Database of Systematic Reviews
John H Riley, Maggie Tabberer, Nathalie Richard, Alison Donald, Alison Church, Stephanie S Harris
BACKGROUND: Handheld inhalers are used to deliver treatment for COPD. Incorrect usage leads to suboptimal disease control. Complex treatment regimens and use of multiple inhalers may reduce patient compliance. The Anoro Ellipta™ dry powder inhaler (DPI) simultaneously delivers umeclidinium bromide (UMEC) and vilanterol (VI) without coformulation being required. AIM: To assess the correct usage and ease of use of the Ellipta™ DPI administering UMEC/VI and to compare patient preference for Ellipta™ with the HandiHaler(®) through exploratory analyses of patient and observer questionnaires in five Phase III studies...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Li Wang, Chun-Juan Zhai, Yao Liu, Yi Liu, Shu-Juan Jiang
BACKGROUND: The role of umeclidinium plus vilanterol as a combination therapy for chronic obstructive pulmonary disease (COPD) has not yet been clearly defined. OBJECTIVE: The aim of this meta-analysis was to evaluate the efficacy and safety of umeclidinium plus vilanterol, in contrast to either monotherapy or placebo. METHODS: Systematic searches were conducted in Pubmed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and the Chinese Biomedical Literature Database (CBM)...
November 2016: Clinical Drug Investigation
Ian D Pavord, Sally Lettis, Antonio Anzueto, Neil Barnes
BACKGROUND: Inhaled corticosteroids are important in the management of chronic obstructive pulmonary disease (COPD), but can slightly increase the risk of pneumonia in patients with moderate-to-severe COPD. Patients with circulating eosinophil counts of 2% or more of blood leucocytes respond better to inhaled corticosteroids than do those with counts of less than 2% and it was therefore postulated that blood eosinophil count might also have an effect on the risk of pneumonia in patients with COPD...
September 2016: Lancet Respiratory Medicine
Paolo Montuschi, Mario Malerba, Giuseppe Macis, Nadia Mores, Giuseppe Santini
Combining individual drugs in a single inhaler is the most convenient way to deliver triple therapy. A long-acting muscarinic receptor antagonist (LAMA) added to an inhaled corticosteroid (ICS)/long-acting β2-adrenoceptor agonist (LABA) fixed-dose combination (FDC) can improve efficacy of pharmacological treatment of patients with chronic obstructive pulmonary disease (COPD). New inhaled ICS/LABA/LAMA FDCs, including fluticasone furoate/vilanterol/umeclidinium, budesonide/formoterol/glycopyrronium and beclometasone/formoterol/glycopyrronium, are in Phase III of clinical development for COPD...
July 21, 2016: Drug Discovery Today
Dave Singh, M Reza Maleki-Yazdi, Lee Tombs, Ahmar Iqbal, William A Fahy, Ian Naya
BACKGROUND: Minimizing the risk of disease progression and exacerbations is the key goal of COPD management, as these are well-established indicators of poor COPD prognosis. We developed a novel composite end point assessing three important aspects (lung function, health status, and exacerbations) of worsening in COPD. The objective was to determine whether dual bronchodilation with umeclidinium/vilanterol (UMEC/VI) reduces clinically important deteriorations (CIDs) in COPD versus placebo or bronchodilator monotherapy...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Steven J Pascoe, David A Lipson, Nicholas Locantore, Helen Barnacle, Noushin Brealey, Rajat Mohindra, Mark T Dransfield, Ian Pavord, Neil Barnes
Patients with symptomatic advanced chronic obstructive pulmonary disease (COPD) who experience recurrent exacerbations are particularly at risk of poor outcomes and present a significant burden on healthcare systems. The relative merits of treating with different inhaled combination therapies e.g. inhaled corticosteroids (ICS)/long-acting β2-agonist (LABA), LABA/long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, in this patient group are poorly understood, as is reflected in current guidelines. The InforMing the PAthway of COPD Treatment (IMPACT) study will evaluate the efficacy and safety of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus FF/VI or UMEC/VI over a 52-week treatment period...
August 2016: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Jiangtao Lin, Huaping Tang, Ping Chen, Haoyan Wang, Mi-Kyeong Kim, Jodie Crawford, Loretta Jacques, Sally Stone
BACKGROUND: Response to inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combinations varies across ethnic groups. OBJECTIVE: To investigate the efficacy and safety of the ICS/LABA combination fluticasone furoate/vilanterol (FF/VI) 100/25 μg in Asian patients with asthma. METHODS: A randomized (1:1), 12-week, double-blind, placebo-controlled, parallel group, multicenter phase III study of once-daily FF/VI 100/25 μg versus placebo in patients of Asian ancestry ages ≥12 years with asthma, uncontrolled on a low- to mid-strength ICS or low-dose ICS/LABA...
July 2016: Allergy and Asthma Proceedings:
Roberto W Dal Negro, Chiara Distante, Luca Bonadiman, Paola Turco, Sergio Iannazzo
BACKGROUND: Asthma is a disease with high cost for the National Health Service. Two of the most recent LABA/ICS combinations for persistent bronchial asthma are Beclomethasone dipropionate/Formoterol (B/F) delivered via the Nexthaler device and Fluticasone furoate/Vilanterol (F/V) delivered via the Ellipta device. No comparison has been carried out yet in terms of cost analysis in asthma, to our knowledge. Aim of the present monocentric, observational, retrospective study was to calculate and compare the costs of mild-to-moderate asthma patients assuming B/F 100/6 μg b...
2016: Multidisciplinary Respiratory Medicine
Thomas M Siler, Alison C Donald, Dianne O'Dell, Alison Church, William A Fahy
BACKGROUND: The combination of the inhaled muscarinic antagonist umeclidinium (UMEC) with the long-acting β2-agonist vilanterol (VI) has been shown to provide significant improvements in lung function compared with UMEC, VI, or placebo (PBO) in patients with chronic obstructive pulmonary disease (COPD). This study was specifically designed to support these findings by assessing health-related quality of life and symptomatic outcomes in a similar population. METHODS: This was a 12-week multicenter, randomized, double-blind, parallel-group, placebo-controlled study...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Suzanne G Bollmeier, Theresa R Prosser
OBJECTIVE: Fluticasone furoate (FF), an inhaled corticosteroid (ICS), and vilanterol (VI), a long-acting beta2 receptor agonist (LABA), is a new combination used in an Ellipta(®) device. This article compares FF-VI to other ICS-LABA combinations available, particularly emphasizing product selection from the patient perspective. DATA SOURCES: A PubMED and EMBASE search completed in October 2015 identified trials using the MeSH terms "fluticasone", "vilanterol", and "asthma"...
2016: Patient Preference and Adherence
(no author information available yet)
Maltais, F., Singh, S., Donald, A., Crater, G., Church, A., Goh, A. et al. (2014) Effects of a combination of umeclidinium/vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials. Ther Adv Respir Dis 8: 169-181.
June 2016: Therapeutic Advances in Respiratory Disease
Ichiro Kuwahira
Several new fixed-dose combination bronchodilators have been launched in the world, and 3 different types are now available in Japan. Assessing their efficacy relative to each other has not been performed yet. In the present manuscript, characteristics of glycopyrronium/indacaterol, umeclidinium/vilanterol and tiotropium/olodaterol were reviewed. In particular, changes in trough and peak forced expiratory volume in 1 second (FEV1), St George's Respiratory Questionnaire (SGRQ) total scores, and transitional dyspnea index (TDI) focal scores were reviewed in these bronchodilators...
May 2016: Nihon Rinsho. Japanese Journal of Clinical Medicine
Hiroaki Kume
Long-acting β2-adrenergic receptor agonists (LABAs) and anticholinergics (LAMAs) are widely used clinically as therpy for COPD. Clinical reports have demonstrated that LABAs (salmeterol, formoterol, indacaterol, olodaterol, vilanterol) and LAMAs (tiotropium, glycopyrronium, umeclidinium, aclidinium) are useful to improving symptoms and lung function, and to reducing exacerbation and hospitarization. LABAs expect salmeterol are strong partial agonists, and LAMAs are non-specific antagonists. Ca2+ dynamics and Ca2+ sensitization contribute to relaxation of airway smooth muscle in these bronchodilators...
May 2016: Nihon Rinsho. Japanese Journal of Clinical Medicine
Luigino Calzetta, Barbara Rinaldi, Mario Cazzola, Maria Gabriella Matera
The pharmacokinetic (PK) and pharmacodynamic (PD) effects of long-acting β2-agonists and mostly inhaled corticosteroids (ICSs) shape the efficacy and safety of these agents in the treatment of asthma. In fact, the PK and PD characteristics of the drug largely determine the degree of pulmonary targeting Areas covered. In this review, we summarize the PK and PD properties of inhaled fluticasone furoate (FF) and vilanterol trifenatate (VI) and their fixed-dose combination (FDC) for the treatment of asthma Expert opinion...
July 2016: Expert Opinion on Drug Metabolism & Toxicology
David R Hinds, Rachael L DiSantostefano, Hoa V Le, Steven Pascoe
OBJECTIVES: To identify clusters of patients who may benefit from treatment with an inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) versus LABA alone, in terms of exacerbation reduction, and to validate previously identified clusters of patients with chronic obstructive pulmonary disease (COPD) (based on diuretic use and reversibility). DESIGN: Post hoc supervised cluster analysis using a modified recursive partitioning algorithm of two 1-year randomised, controlled trials of fluticasone furoate (FF)/vilanterol (VI) versus VI alone, with the primary end points of the annual rate of moderate-to-severe exacerbations...
2016: BMJ Open
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