Hru data were captured remotely in realtime via pts electronic health records. The salford lung study is a phase iiib multicentre, open label. The salford lung study sls subjects represent a group of copd and asthma patients whose disease is extremely wellcharacterised over a short time period. The salford lung study had minimal exclusion criteria and involved a broad demographic of patients. Sls will evaluate the effectiveness and safety of the ffvi combination compared with existing maintenance therapy in a large, realworld population of patients with copd in conditions of normal care. Introduction and objectives the salford lung study in asthma, an openlabel, randomised controlled trial, evaluated the effectiveness of initiating oncedaily inhaled fluticasone furoatevilanterol ffvi versus continuing usual care uc in a large, realworld population of patients with asthma in uk primary care. The salford lung study was designed to evaluate the effectiveness and safety of the oncedaily inhaled combination of fluticasone furoate and vilanterol fluticasone furoatevilanterol as. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention.
Salford lung study reports successful asthma trial. Salford lung study reports successful asthma trial research. The salford lung study in copd reported findings in may 2016. A second salford lung study is currently being conducted in patients with asthma, with results expected in 2017. However these efficacy rcts have limited relevance to everyday clinical 108 practice, and so there has been a call for comparative. Asthma is a chronic lung disease that inflames and narrows the airways. This was the first effectiveness rct of its kind in uk primary care with. The salford lung study sls was a worldfirst, prospective, phase iii, pragmatic randomised controlled trial rct programme in patients with chronic obstructive pulmonary disease and asthma to. Relvar ellipta significantly improved asthma control in. Positive results from the copd salford lung study published. Salford lung study in asthma clinical trial randomized. Anonymised individual participant data from this study plus the annotated case report form, protocol. Positive results from pioneering salford lung study in asthma. Sls copd was a 52week, prospective, comparative, openlabel, randomised controlled trial rct conducted in the city of salford in the uk.
Effectiveness of fluticasone furoatevilanterol in asthma. Effectiveness of fluticasone furoatevilanterol versus fluticasone propionatesalmeterol on asthma control in the salford lung study. Patients aged 18 years or older with a general practitioners diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a oncedaily inhaled combination of either 100. Effectiveness of fluticasone furoate plus vilanterol on. Dec 15, 2017 the salford lung study in copd sls copd was a clinical trial conducted in a uk primary care population that was designed to be representative of patients with copd in routine clinical practice. The salford lung study sls programme, encompassing two studies, is a pre.
The salford lung study is intended to enable healthcare professionals and decision makers to more fully assess the potential value of ffvi by providing data collected in a normal clinical. We did an openlabel, randomised, controlled, twoarm effectiveness trial at 74 general practice clinics in salford and south manchester, uk. The salford lung study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of oncedaily fluticasone furoate 100. Salford lung study asthma results published northwest. This was the first effectiveness rct of its kind in uk primary care with broad inclusion criteria. The salford lung study on copd 5 showed that, compared with continuation of usual care, initiation of the oncedaily combination of fluticasone furoate and vilanterol reduced moderate and severe exacerbations. Evidence notes issue seven june 2016 issue seven june. The salford lung study was a clinical trial which began recruitment in 2012, with the basis that enrolment would be open to a much broader population with a diagnosis of chronic obstructive pulmonary disease copd or asthma in the region, regardless of whether or not they had other conditions such as cancer or high blood pressure. Healthcare professionals from eight organisations across greater manchester have collaborated to deliver the initial results of the salford lung study sls. Consent in the salford lung study the process of consent and randomisation was supported by study staff consent forms were available in different languages and in audio format consent was obtained by the patients gp in their usual practice some sites used study nurses to take patients through the consent process. The salford lung study sls of patients with asthma and chronic obstructive pulmonary disease copd is a practical, communitybased, randomized, openlabel pragmatic study on the efficacy and. What im going to be talking about, is a little bit about the background of this study, why we did it, a little about how we did it, and also tell you a bit about the results, and some of the outcomes from this study. The salford lung study on copd5 showed that, compared with continuation of usual care, initiation of the oncedaily combination of fluticasone furoate and vilanterol reduced moderate and severe exacerbations. Sls asthma is the worlds first large prospective asthma effectiveness randomised controlled trial rct.
The study generated effectiveness and safety data for relvar fluticasone furoatevilanterol ffvi, 9222 mcg in a population of patients with copd. Evidence notes issue seven june 2016 3 according to the authors, the salford lung study in asthma and copd is worlds first preapproval phase iii randomised pct21 and, although ongoing, is a useful case study to explore. Salford lung study asthma results published northwest ehealth. A descriptive followup interview study assessing patient. The salford lung study is important as one of the first clinical effectiveness studies. The usual way of investigating new medicine is to use a double blind, randomised controlled trial rct the gold. We now report the results of the salford lung study on asthma, which compared the effectiveness of the fluticasone furoate and. Copd and asthma prevalence is associated with socioeconomic status or deprivation, yet deprivation is rarely considered in typical largescale efficacy randomised controlled trials that recruit highly selected patient populations. The results of the successful asthma arm of the salford lung study sls have been announced.
Lung study in asthma that are being presented and published today showing that relvar ellipta was superior to usual care treatment in improving asthma control. In this post hoc analysis of the salford lung studies in copd and asthma two 12month, openlabel, effectiveness. Relvar elliptasignificantly improved asthma control in. Effectiveness of fluticasone furoatevilanterol versus. Salford lung study feasibility hanaa f elkhenini1,2, kourtney j davis3,4, norman d stein1,2, john p new1,2, mark r delderfield1,2, martin gibson1,2. Sls copd nct015517581 was a 12month, openlabel, randomised controlled trial rct that evaluated the effectiveness and safety of initiating fluticasone furoatevilanterol 10025g vs continuing usual care in copd patients pts with exacerbation exa history vestbo et al. The highly anticipated results from the salford lung study were announced by gsk on 5th may 2017. The salford lung study sls of patients with asthma and chronic obstructive pulmonary disease copd is a practical, communitybased, randomized, openlabel pragmatic study. The salford lung studies sls are groundbreaking trials designed to study the effectiveness and safety of initiating treatment with relvar ellipta in patients with asthma and copd versus existing continuing maintenance therapy. Sep 04, 2016 a second salford lung study is currently being conducted in patients with asthma, with results expected in 2017. Pioneering gsk study provides important new data on the effectiveness of relvar ellipta ffvi when used in everyday clinical practice.
The salford lung study is important as one of the first clinical effectiveness studies of its kind, providing interesting insights into the management of asthma in clinical care. Global initiative for asthma, gina 106 are almost entirely based on efficacy rcts in highly selected and closely monitored patient 107 populations. An effectiveness study comparing fluticasone furoate ff. Set in salford and southern manchester districts, uk the sls asthma study rw01.
Relvar ellipta significantly improved asthma control in salford lung study patients compared with their usual care. The salford lung study in asthma sls asthma is a 12month, openlabel randomised clinical trial comparing clinical effectiveness of initiating oncedaily inhaled combination of fluticasone furoatevilanterol ffvi 18422 mcg or 9222 mcg, with continuing optimized usual care uc with inhaled corticosteroids ics alone, or in combination with a. Study investigating the generalisability of a copd trial. This study develops novel methods to evaluate the presence of a hawthorne effect operating for a trial, such as the salford lung study in copd, which was conducted in the setting of everyday clinical practice. Jan 11, 2020 the salford lung study sls was a worldfirst, prospective, phase iii, pragmatic randomised controlled trial rct programme in patients with chronic obstructive pulmonary disease and asthma to evaluate the effectiveness of a prelicensed medication fluticasone furoatevilanterol in realworld practice using electronic health records and. The asthma salford lung study demonstrated the effectiveness of initiating oncedaily fluticasone furoatevilanterol ffvi versus continuing usual care in asthma patients in uk primary care 1 woodcock a, vestbo j, bakerly nd, new j, gibson jm, mccorkindale s, jones r, et al. Oct 15, 2012 jacques l, bakerly nd, new jp, svedsater h, layflurrie j, leather da. And i was one of the leads on the salford lung study. The salford lung study sls programme, encompassing two phase iii pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once. Using an electronic medical record emr to conduct clinical. Patient demographics and clinical characteristics in the. Salford lung study in asthma free download as pdf file. Aug 15, 2019 the salford lung study in asthma sls asthma was a multicentre, randomised, controlled, openlabel trial that assessed initiating oncedaily, singleinhaler fluticasone furoatevilanterol ffvi.
Research article open access using an electronic medical record emr to conduct clinical trials. Study of an experimental drug in asthma and copd 7 7000 patients from a single city well defined nhs area with a strong academic centre minimal exclusion criteria active recruitment resource randomised, open label design, 1 year follow up free choice mixed comparator arm. Sep 11, 2017 the salford lung study is important as one of the first clinical effectiveness studies of its kind, providing interesting insights into the management of asthma in clinical care. The study was initiated before this investigational.
The salford lung study sls is the worlds first pragmatic rct prct of an investigational medication. Dec 10, 2015 the salford lung study is the worlds first pragmatic randomised controlled trial of a prelicensed medication in asthma. Effectiveness of fluticasone furoatevilanterol for copd. Today im going to be talking about the salford lung study, in copd. The salford lung study 5 104 research in context 105 guidelines for the routine management of asthma e. Effectiveness in asthma control real world evidence. The salford lung study in copd sls copd was a clinical trial conducted in a uk primary care population that was designed to be representative of patients with copd in routine clinical practice.
At week 24, the odds of patients being act responders total score. Salford lung study in chronic obstructive pulmonary disease. Effectiveness of fluticasone furoatevilanterol for copd in. The sls, sponsored by gsk, examined the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease copd and asthma. The salford lung study sls of patients with asthma and chronic obstructive pulmonary disease copd is a practical, communitybased, randomized, openlabel pragmatic study on the efficacy and safety of the oncedaily dry powder inhaler that combines the inhaled corticosteroid fluticasone furoate ff with the longacting beta 2. In this post hoc analysis of the salford lung studies in copd and asthma two 12month, openlabel, effectiveness randomised controlled trials conducted in.
Positive results from pioneering salford lung study in. Relvar ellipta salford lung study sls pioneering asthma study results. Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice. Respiratory medicine vol 141, pages 1206 august 2018. We now report the results of the salford lung study on asthma, which compared the effectiveness of the. The salford lung study in asthma sls asthma was a multicentre, randomised, controlled, openlabel trial that assessed initiating oncedaily, singleinhaler fluticasone furoatevilanterol ffvi. Challenges and complexities with the reporting of electronic medical record data in a pioneering phuse 2018, frankfurt 6 and novel approach to clinical trials manchester london salford randomised openlabel, parallel group design 12.
Subjects in the sls originally consented for information relevant to the study to be shared with the sponsor gsk. Salford lung study in asthma relvar ellipta fluticasone. Patientreported outcomes with initiation of fluticasone furoatevilanterol versus continuing usual care in the asthma salford lung study henrik svedsater. This is the second of the two salford lung studies to report. Impact of socioeconomic status on participation and. Salford lung study feasibility hanaa f elkhenini1,2, kourtney j davis3,4, norman d stein1,2, john p new1,2, mark r delderfield1,2, martin gibson1,2, jorgen vestbo1,5, ashley woodcock1,5 and nawar diar bakerly1,2 abstract. Salford lung study in chronic obstructive pulmonary. Patient demographics and clinical characteristics in the uk. The salford lung study is the worlds first phase iii prct in asthma and chronic obstructive pulmonary disease copd, which aims to randomise over 7000 patients. Use of patients linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. The salford lung study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of.
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