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      Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma

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          Abstract

          The inhaled corticosteroid fluticasone furoate (FF) and the long-acting β 2 agonist vilanterol (VI) are in development as a combined once-daily therapy for asthma and chronic obstructive pulmonary disease. Our study objectives were to compare the efficacy and safety of once-daily FF/VI with FF alone and twice-daily fluticasone propionate (FP) in patients aged ≥12 years with moderate-to-severe persistent asthma.

          Patients (n=586) received FF/VI 200/25 μg or FF 200 μg once-daily (evening dosing), or FP 500 μg twice-daily for 24 weeks. Co-primary end-points were change from baseline in trough forced expiratory volume in 1 s (FEV 1) weighted mean (wm) 0–24 h serial FEV 1. Secondary end-points included change from baseline in percentage of rescue-free 24-h periods, percentage of symptom-free 24-h periods and total Asthma Quality of Life Questionnaire (AQLQ). Safety assessments included adverse events, 24-h urinary cortisol excretion, vital signs and ECG.

          FF/VI significantly improved trough FEV 1 and wmFEV 1 versus FF and FP. Significantly more rescue-free and symptom-free 24-h periods were reported with FF/VI versus FF. Treatment differences for AQLQ were not significant. Incidence of adverse events was similar across groups. No clinically significant differences were seen for 24-h urinary cortisol excretion, vital signs or ECG.

          FF/VI resulted in statistically greater improvements in lung function and symptomatic end-points versus FF, and was well tolerated in this asthma population.

          Abstract

          Fluticasone furoate (FF)/vilanterol improved lung function and symptomatic end-points compared with FF alone http://www.ow.ly/siK33

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          Most cited references12

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          Asthma.

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            Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial.

            This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta(2) agonists, and to determine the dose(s) suitable for further development. Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV(1)). A dose-response effect was observed for once-daily FF 25-200 μg including (p  200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects. FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation. ClinicalTrials.gov: NCT00603382. Copyright © 2012 Elsevier Ltd. All rights reserved.
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              Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children.

              Long-acting inhaled ss(2)-adrenergic agonists (LABAs) are recommended as 'add-on' medication to inhaled corticosteroids (ICS) in the maintenance therapy of asthmatic adults and children aged two years and above. To quantify in asthmatic patients the safety and efficacy of the addition of LABAs to ICS in patients insufficiently controlled on ICS alone. We identified randomised controlled trials (RCTs) through electronic database searches (the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE and CINAHL), bibliographies of RCTs and correspondence with manufacturers until May 2008. We included RCTs if they compared the addition of inhaled LABAs versus placebo to the same dose of ICS in children aged two years and above and in adults. Two review authors independently assessed studies for methodological quality and extracted data. We obtained confirmation from the trialists when possible. The primary endpoint was the relative risk (RR) of asthma exacerbations requiring rescue oral corticosteroids. Secondary endpoints included pulmonary function tests (PFTs), rescue beta2-agonist use, symptoms, withdrawals and adverse events. Seventy-seven studies met the entry criteria and randomised 21,248 participants (4625 children and 16,623 adults). Participants were generally symptomatic at baseline with moderate airway obstruction despite their current ICS regimen. Formoterol or salmeterol were most frequently added to low-dose ICS (200 to 400 microg/day of beclomethasone (BDP) or equivalent) in 49% of the studies. The addition of a daily LABA to ICS reduced the risk of exacerbations requiring oral steroids by 23% from 15% to 11% (RR 0.77, 95% CI 0.68 to 0.87, 28 studies, 6808 participants). The number needed to treat with the addition of LABA to prevent one use of rescue oral corticosteroids is 41 (29, 72), although the event rates in the ICS groups varied between 0% and 38%. Studies recruiting adults dominated the analysis (6203 adult participants versus 605 children). The subgroup estimate for paediatric studies was not statistically significant (RR 0.89, 95% CI 0.58 to 1.39) and includes the possibility of the superiority of ICS alone in children.Higher than usual dose of LABA was associated with significantly less benefit. The difference in the relative risk of serious adverse events with LABA was not statistically significant from that of ICS alone (RR 1.06, 95% CI 0.87 to 1.30). The addition of LABA led to a significantly greater improvement in FEV(1) (0.11 litres, 95% 0.09 to 0.13) and in the proportion of symptom-free days (11.88%, 95% CI 8.25 to 15.50) compared to ICS monotherapy. It was also associated with a reduction in the use of rescue short-acting ss(2)-agonists (-0.58 puffs/day, 95% CI -0.80 to -0.35), fewer withdrawals due to poor asthma control (RR 0.50, 95% CI 0.41 to 0.61), and fewer withdrawals due to any reason (RR 0.80, 95% CI 0.75 to 0.87). There was no statistically significant group difference in the risk of overall adverse effects (RR 1.00, 95% 0.97 to 1.04), withdrawals due to adverse health events (RR 1.04, 95% CI 0.86 to 1.26) or any of the specific adverse health events. In adults who are symptomatic on low to high doses of ICS monotherapy, the addition of a LABA at licensed doses reduces the rate of exacerbations requiring oral steroids, improves lung function and symptoms and modestly decreases use of rescue short-acting ss(2)-agonists. In children, the effects of this treatment option are much more uncertain. The absence of group difference in serious adverse health events and withdrawal rates in both groups provides some indirect evidence of the safety of LABAs at usual doses as add-on therapy to ICS in adults, although the width of the confidence interval precludes total reassurance.
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                Author and article information

                Journal
                Eur Respir J
                Eur. Respir. J
                erj
                The European Respiratory Journal
                European Respiratory Society (442 Glossop Road, Sheffield, S10 2PX, UK )
                0903-1936
                1399-3003
                March 2014
                17 October 2013
                : 43
                : 3
                : 773-782
                Affiliations
                [1 ]Michael G. DeGroote School of Medicine , Hamilton, ON, Canada
                [2 ]Center for Genomics and Personalized Medicine, Wake Forest University School of Medicine , Winston-Salem, NC
                [4 ]Dept of Medicine, University of Wisconsin , Madison, WI
                [6 ]Quantitative Sciences Division , GlaxoSmithKline, Research Triangle Park, NC
                [7 ]Respiratory Medicines Development Center , GlaxoSmithKline, Research Triangle Park, NC, USA
                [3 ]Dept of Medicine, University of Cape Town , Cape Town, South Africa
                [5 ]Institute of Inflammation and Repair, University of Manchester , Manchester
                [8 ]Respiratory Medicines Development Centre , GlaxoSmithKline, London, UK
                [9 ]Krefting Research Centre, University of Gothenburg , Gothenburg, Sweden
                Author notes
                P.M. O’Byrne, Dept of Medicine, Michael G. DeGroote School of Medicine, McMaster University, 1280 Main Street West, Room 3W10, Hamilton, ON, L8S 4K1, Canada. E-mail: obyrnep@ 123456mcmaster.ca
                Article
                erj00645-2013
                10.1183/09031936.00064513
                3938760
                24136330
                5c4787cb-10f2-41f4-8cef-de5f1a7be8e3
                ©ERS 2014

                ERJ Open articles are open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 3.0.

                History
                : 11 April 2013
                : 28 August 2013
                Categories
                Original Articles
                Asthma
                14

                Respiratory medicine
                Respiratory medicine

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