The combination of fluticasone furoate ff, a novel inhaled corticosteroid ics, and vilanterol vi, a longacting. Key messages identified by individual workshop participants. The salford lung studiesthe first studies to evaluate the effectiveness of a prelicense drug in a realworld. Salford lung study ambition study as near to real world as possible using a prelicense medicine embrace heterogeneity of patient population normalise the patient experience as much as. Ukindia oncology week 05 24 uk stratified medicine uk stratified medicine 25 glaxosmithkline is testing the effectiveness of a prelicence medicine glaxosmithkline is testing the effectiveness of. Sep 04, 2015 the salford lung study sls is the worlds first pragmatic rct prct of an investigational medication. The salford lung study team sought scientific advice by means of a joint consultation process with the national institute for health and care excellence and the medicines and healthcare products. The salford lung study in asthma sls asthma was a multicentre, randomised, controlled, openlabel trial that assessed initiating oncedaily, singleinhaler fluticasone furoatevilanterol ffvi.
The salford lung study is an openlabel, phase 3b, controlled, multicentre, randomized clinical trial mainly aimed at comparing the safety profile and effectiveness of ffvi treatment and the current copd therapy. Glaxosmithkline reported positive results from the pioneering salford lung study sls evaluating relvar ellipta 10025 mcg for the treatment of exacerbations in patients with. 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. The salford lung study is a phase iiib multicentre, open label randomised. 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. Albertson te, murin s, sutter me, chenoweth ja pragmat obs res, 8. Salford lung study results show copd patients treated with. May 24, 2016 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. Today im going to be talking about the salford lung study, in copd. 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. We can then advise as to whether the results from the.
Positive results from pioneering salford lung study in. The realworld aspect of sls was unique, requiring careful planning and. The results show a superior reduction in exacerbations for copd patients on relvar ellipta salford lung study results. Data from the study was presented at the european respiratory society ers international congress on sunday 4th september in london. Salford lung study in chronic obstructive pulmonary disease sls copd. Using an electronic medical record emr to conduct clinical. Impact of socioeconomic status on participation and outcomes. Take one city, 233,900 inhabitants, 3000 trained healthcare professionals and study facilitators and 235 million rows of data, and you have a research ready city. The salford lung study sls of patients with asthma and. Dec 10, 2015 the study utilises the salford electronic medical record, which allows near to realtime collection and monitoring of safety data. Compare, in a realworld setting, the safety and efficacy of relvar ellipta, with existing maintenance therapy for copd and asthma in a general practice setting in the uk provide relevant and. What is driving the desire for pragmatic clinical trials.
The innovative realworld setting was a risk, but ultimately gsk. Sep 08, 2016 glaxosmithkline and innoviva have finally provided greater detail on the salford lung study at the european respiratory congress. The objective of the study was to compare the effectiveness and safety profile of ffvi 10025mcg with existing copd usual care. Salford lung study for the conduct of an observational. Background epidemiological studies on the effect of urban air pollution on childhood asthma have shown conflicting results and so far no consistent association has emerged. A second salford lung study is also being conducted in patients with asthma. Salford lung study asthma results published northwest ehealth. Relvar ellipta significantly improved asthma control in salford lung study patients compared with their usual care. 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 for the conduct of an observational study comparing the generalisability of sls patients to those in cprd. Jun 01, 2016 the company added that it is continuing to conduct clinical assessments, and the results will soon be reported in future publications and presentations.
Salford lung study shows reduction in copd exacerbations. Apr 20, 2017 the salford lung study has been designed to explore how effective a treatment for chronic obstructive pulmonary disease, or copd, and asthma is, when it is used in everyday clinical practice. 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. The salford lung study investigated the effectiveness of a combination of oncedaily fluticasone furoatevilanterol ffvi compared with existing maintenance therapy. Sls copd helps us to assess the clinical value and potential benefits of relvar as. Headline results from the 2,802patient salford lung study sls in copd demonstrated that the inhaled therapy achieved a superior reduction in exacerbations versus usual care which included long. Pdf realworld data and randomised controlled trials. 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.
The study generated effectiveness and safety data for relvar fluticasone furoatevilanterol ffvi, 9222 mcg in a population of patients with copd intended to represent that seen in everyday clinical practice. Promising copd data revealed for relvar ellipta in salford. 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 in chronic obstructive pulmonary. Study investigating the generalisability of a copd trial. Published in august 2017, the strategy sets out recommendations for our world. A second salford lung study is ongoing in patients with asthma, with glaxosmithkline expecting to report results next year.
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. Salford lung study sls gskpro for healthcare professionals. Dec 10, 2015 novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in realworld settings. Pioneering gsk study provides important new data on the effectiveness of relvar. Gsk announce positive results from the copd salford lung. The results show a superior reduction in exacerbations for. As such, well designed prcts may offer complementary data to these standard types of studies, representing true realworld effectiveness. Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in realworld settings. Sep 06, 2016 glaxosmithkline gsk has announced full results from the salford lung study sls, a pioneering study of copd treatment aimed at creating a clinical trial much closer to everyday clinical practice. A pragmatic, randomised phase iii realworld effectiveness trial in asthma article pdf available in bmc pulmonary medicine 151.
Research article open access using an electronic medical record emr to conduct clinical trials. Jun 02, 2016 study results are currently under evaluation. Efficacy and safety of fluticasone furoatevilanterol. We now report the results of the salford lung study on asthma, which. 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. Lung remodelling caused by smoking 16 afsaneh tayyar salford art photography and nature 17 nahid bashatah salford media the stereotypes of saudi. Pioneering lung study in salford the hippocratic post. Realworld data on the benefitrisk profile of medicines is needed, particularly in patients who are ineligible for randomised controlled trials conducted for registration purposes. 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. We now report the results of the salford lung study on asthma, which compared the effectiveness of the fluticasone furoate and. The life sciences sector deal builds on the ambitious life sciences industrial strategy, led by professor sir john bell. The salford lung study is a phase iii multicentre, open label randomised controlled trial rct.
Salford lung study feasibility hanaa f elkhenini1,2, kourtney j davis3,4, norman d stein1,2, john. A second salford lung study is currently being conducted in asthma patients, with results expected in 2017. Effectiveness of fluticasone furoate plus vilanterol on. Positive results from pioneering salford lung study in asthma. 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. 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. The salford lung study in chronic obstructive pulmonary disease sls copd was a phase iiib rct conducted in uk primary care that evaluated the clinical effectiveness and safety of initiating oncedaily inhaled fluticasone furoatevilanterol ffvi 10025 g versus continuing usual care uc in patients with copd and exacerbation history. Reducing patient burden remote endpoint monitoring. We now report the results of the salford lung study on asthma. Pioneering gsk study provides important new data on the effectiveness of relvar ellipta ffvi when used in everyday clinical practice.
Headline results from the 2,802patient salford lung study sls in copd demonstrated that the inhaled therapy achieved a superior reduction in exacerbations versus usual care which included longacting muscarinic antagonists lama, longacting beta2agonists laba, and inhaled corticosteroids ics in an everyday clinical practice setting. Relvar ellipta significantly improved asthma control in. The salford lung study is the worlds first pragmatic randomised controlled trial of a prelicensed medication in asthma. The salford lung study is a phase iiib multicentre, open label randomised controlled trial rct. This large prospective study is sponsored by the global. The extended salford lung study ex sls data access project the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Sls will evaluate the effectiveness and safety of the ffvi combination. The extended salford lung study ex sls data access project. The clinical status and economic savings associated with remission among patients with rheumatoid arthritis.
These studies were done in and around salford, uk, a community mainly. The objective of this study was to compare the effectiveness and safety profile of. Gsks relvar ellipta hits the mark in copd trial pharmatimes. The salford lung study is the worlds first pragmatic, realworld study initiated on what was, at the time, a prelicence medicine. Could a new research partnership make manchester healthier.
This is a positive result for the study sponsor, gsk, and for the study partners as a group. Pdf the salford lung study sls of patients with asthma and chronic obstructive pulmonary disease copd is a practical. I am coinvestigator of this observational study i have participated in. Doward l, svedsater h, whalley d, crawford r, leather d, layflurrie j, bosanquet n.
The salford lung study is an exciting and unique research project which will be focusing on asthma and copd. Jun 10, 2016 the salford lung study, whose results were reported in may 2016, is considered something of a microexample of what hinm could achieve on a conurbationwide scale. Information describing what is the salford lung study sls. Effectiveness of fluticasone furoatevilanterol for copd. Patient distribution by deprivation quintile in the salford lung study sls of copd and the sls of asthma total study populations. The salford lung study is the worlds first phase iii prct in asthma and chronic.
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. Healthcare professionals from eight organisations across greater manchester have collaborated to deliver the initial results of the salford lung study sls. The salford lung study sls is the worlds first pragmatic rct prct of an investigational medication. 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 on the efficacy and safety of the oncedaily dry powder inhaler that combines the inhaled corticosteroid fluticasone furoate ff with the longacting beta2 agonist vilanterol vi. 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. Robust effectiveness evidence would be of particular value in assessing oncedaily inhaled therapies for asthma and copd, where improved outcomes may result from better adherence. We now report the results of the salford lung study on asthma, which compared the effectiveness of the. The salford lung study sls of patients with asthma and chronic. The study utilises the salford electronic medical record, which allows near to realtime collection and monitoring of safety data.
Sls copd was a 52week, prospective, comparative, openlabel, randomised controlled trial rct conducted in the city of salford in the uk. Salford lung study asthma results published northwest. 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. The salford lung study is an openlabel phase iii prct of a oncedaily longacting. The objective of this study was to compare the effectiveness and safety profile of initiating treatment with ffvi with usual asthma maintenance therapy over a 52 week period. Impact of socioeconomic status on participation and. Lung remodelling caused by smoking 16 afsaneh tayyar salford art photography and nature 17 nahid bashatah salford media the stereotypes of saudi women in british press 18 holly matthews salford science optimisation of fluorescence based in vitro drug susceptibility assays. This can only be investigated in a realworld effectiveness study, such as the salford lung study, which is now under way.
Listing a study does not mean it has been evaluated by the u. Percentages are based on a denominator of the number of patients with available deprivation data. Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness. The study involved over 2,800 consenting patients, supported by 80 gp practices and pharmacies in salford and the surrounding greater manchester area.
Salford, a metropolitan borough of greater manchester, recently became the first place in the world to host a realworld study of what was, at the time, a prelicence medicine for lung disease, one of gsks inhaled copd and. Salford lung study shows reduction in copd exacerbations with. The aim of this study was to compare the efficacy of ffvi with fluticasone propionate fpsalmeterol sal in patients with persistent asthma uncontrolled on a medium dose of ics. The salford lung study in chronic obstructive pulmonary disease sls copd was a phase iiib rct conducted in uk primary care that evaluated the clinical effectiveness and safety of. Patient compliance with runin medication was not formally. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The aim of this study is to compare the patients in the standard of care arm of the salford lung study with other copd patients in primary care.
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