This study, which began in 20, is the first ever prospective randomized control trial rct in an everyday health care setting. May 15, 2017 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. Chair of the pharmacy steering group for the salford lung study and european pharmacy adviser for gsk. 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.
And i was one of the leads on the salford lung study. Positive results from pioneering salford lung study in. Svedsater h, doward l, whalley d, crawford r, leather d, layflurrie j, bosanquet n. The salford lung study sls of patients with asthma and chronic. Mar, 2012 a randomised effectiveness study comparing fluticasone furoate ff, gw685698vilanterol vi, gw642444 with standard treatment in chronic obstructive pulmonary disease copd the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Effectiveness of fluticasone furoate plus vilanterol on. Relvar ellipta versus usual care, defined as physicians free choice of lama and or laba only. Poster presented at the 2017 ispor 22nd annual international meeting.
Today im going to be talking about the salford lung study, in copd. With the limitations in observational studies and those in doubleblind rcts 2 such studies alone may not fully reflect the true impact and value. Interpretation of safety findings in clinical effectiveness trials. Researchers see it as a test bed for real world trials that could lead to the quicker introduction of drugs and medical devices. The salford lung study is examining the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease copd in 80 general practices around salford in north west england. Robust effectiveness evidence would be of particular value in assessing oncedaily inhaled therapies for asthma and copd, where improved outcomes may result from better. P269 describing adherence data in a clinical effectiveness. Relvar ellipta salford lung study sls pioneering asthma study results. 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. Catherine bonuccelli, vp, respiratory therapy area head, gsk speaking to ulrich neumann, eyeforpharma on how the salford lung study has changed gsks perspective on how to design and conduct.
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 difference means that subtle benefits from an improved inhaler or a oncedaily regimen could occur in an effectiveness study. Study design and patients this study was a prospective, 12month, openlabel, parallel group, randomised trial done at 74 general practice clinics in salford and south manchester, uk. A second salford lung study is currently being conducted in asthma patients, with results expected in 2017. 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. A second salford lung study is currently being conducted in patients with asthma, with results expected in 2017. Sep, 2017 full results from asthma patients included in the salford lung study provide powerful support for the use of real world effectiveness studies as a more relevant form of evidence to inform prescribing choices and improve patient outcomes, particularly in what turned out to be a general population of asthmatics that were still suffering symptoms under usual care. Followup interviews from the salford lung study copd and. The usual way of investigating new medicine is to use a double blind, randomised controlled trial rct the gold. The salford lung study is a phase iii multicentre, open label randomised controlled trial rct. 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. By contrast, in the salford lung studies, apart from the baseline and 12month visits, there were no planned facetoface visits with the study team.
The salford lung study is the worlds first pragmatic. Glaxosmithkline reported positive results from the pioneering salford lung study sls evaluating relvar ellipta 10025 mcg for the treatment of exacerbations in patients with chronic obstructive pulmonary disease copd. Study design the salford lung study is a phase iiib multicentre, open label. Evidence notes issue seven june 2016 issue seven june. 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. Both study groups receive free prescriptions for study medication, which is collected by the patients from local community pharmacies, and. Patient demographics and clinical characteristics in the. Salford lung study study design1,2 2,802 copd patients usual care. 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. The salford lung study sls is the worlds first pragmatic rct prct of an investigational medication. Positive results from pioneering salford lung study in asthma published in the lancet, and presented at european respiratory congress media first published.
Lessons from gsks salford lung study pink sheet, 9 sep, 2016. The results of the successful asthma arm of the salford lung study sls have been announced. Relvar ellipta significantly improved asthma control in salford lung study patients compared with their usual care. Salford lung study shows reduction in copd exacerbations. The salford lung study is a phase iiib multicentre, open label randomised controlled trial rct. 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.
Positive results from pioneering salford lung study in asthma. The salford lung study is the worlds first phase iii prct in asthma and. Healthcare professionals from eight organisations across greater manchester have collaborated to deliver the initial results of the salford lung study sls. This study is an example of collaboration and community pharmacys contribution in a large multi disciplinary study. Backgroundnovel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in realworld settings. Effectiveness of fluticasone furoatevilanterol for copd in. The study utilises the salford electronic medical record, which allows near to realtime collection and monitoring of safety data. It operates using nhs data to offer the trial resources to the right patients, at the right time in the right way.
Listing a study does not mean it has been evaluated by the u. The salford lung study is the worlds first pragmatic randomised controlled trial of a prelicensed medication in asthma. The salford lung study was an openlabel, randomized, realworld trial comparing a oncedaily inhaler containing the longacting beta2 agonist vilanterol and the inhaled corticosteroid fluticasone. Nct01551758 was a 12month, phase iii, openlabel, randomised, controlled clinical trial that compared the effectiveness and safety of initiating.
The highly anticipated results from the salford lung study were announced by gsk on 5th may 2017. 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 sls of patients with asthma and chronic obstructive pulmonary disease copd is a practical, communitybased, randomized, openlabel pragmatic study on the efficacy and. Salford lung study in chronic obstructive pulmonary. A randomised effectiveness study comparing fluticasone. Nov 22, 2016 glaxosmithkline plcs groundbreaking salford lung study was only possible because salford, in greater manchester, uk, was a truly paperless center that had had for some time an integrated ehealth record system shared between primary and secondary health care, says david leather, md, gsks global medical affairs leader in the respiratory. Set in salford and southern manchester districts, uk the sls asthma study rw01. It evaluates the benefitrisk profile of a combination medication for chronic obstructive pulmonary disease copd. The design of the study was such that the involvement of community pharmacy was a crucial element. Effectiveness of fluticasone furoatevilanterol for copd. We now report the results of the salford lung study on asthma, which compared the effectiveness of the. The salford lung study is an openlabel phase iii prct of a oncedaily longacting.
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. Salford selected for lung disease treatment trial bbc news. The salford lung study sls programme, encompassing two studies, is a pre. 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. Salford lung study in chronic obstructive pulmonary disease. No related items previous abstract next abstract 25 broadway. Sls copd was a 52week, prospective, comparative, openlabel, randomised controlled trial rct conducted in the city of salford in the uk.
Henrik svedsater at glaxosmithkline in the uk, and coworkers, wanted to dig deeper into patient perceptions of copd during the salford lung study in chronic obstructive pulmonary disease sls. The sls, sponsored by gsk, examined the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease copd and asthma. Salford lung study slscopd or asthma trials evaluates. The lung study promising a breath of fresh air in research. Methodsdesignthe salford lung study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of oncedaily fluticasone furoate 100. A pragmatic, randomised phase iii realworld effectiveness trial in asthma article pdf available in bmc pulmonary medicine 151. Patient recruitment for the yearlong study is due to begin in march.
Salford lung study shows reduction in copd exacerbations with. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention. Martin gibson, wei wu, david leather, and jorgen vestbo. Salford lung study reports successful asthma trial. It is the first study of its kind which measures the effectiveness and safety of a medicine while closely reflecting how typical asthma patients are managed in everyday clinical practice, providing meaningful data for the healthcare community. 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 study involved over 2,800 consenting patients, supported by 80 gp practices and pharmacies in salford and the surrounding greater manchester area. Details of the study design and the analysis have been published previously. Pdf the salford lung study sls of patients with asthma and. Sep 08, 2016 glaxosmithkline and innoviva have finally provided greater detail on the salford lung study at the european respiratory congress. 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. 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. 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. Salford lung study in chronic obstructive pulmonary disease sls copd.
Challenges and complexities with the reporting of electronic medical record data in a pioneering phuse 2018, frankfurt and novel approach to clinical trials. The salford lung study is pioneering in the emerging field of gathering realworld evidence. A prospective, randomized realworld effectiveness trial in chronic obstructive pulmonary disease copd. 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. Novel therapies need to be evaluated in normal clinical practice.
Salford lung study for the conduct of an observational study comparing the generalisability of sls patients to those in cprd. Salford lung study ambition study is as near to real world as possible using a prelicense medicine embrace heterogeneity of patient population normalise the patient experience as much as possible pragmatic usual care in each arm relevant endpoints collected maintain scientific rigour. Study investigating the generalisability of a copd trial. The study was initiated before this investigational. Mar 02, 2012 the salford lung study will involve about 4,000 patients with chronic obstructive pulmonary disease copd and 5,000 with asthma. The salford lung study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of oncedaily fluticasone furoate 100. 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. Followup interviews from the salford lung study copd. Realworld evidence and the quest for european market access. The salford lung study broke the mould of clinical trials by harnessing an approach to healthcare data and computing that focuses on populations not hospitals or other organisations. David leather, global medical affairs leader in the respiratory franchise at gsk, led the ukbased study and talked to the pink sheet about why it was important for gsk and what may come next. Salford lung study asthma results published northwest. Salford lung study results show copd patients treated with.
Write to every eligible patient directly from their own gp. The salford lung study is the worlds first phase iii prct in asthma and chronic obstructive. P269 describing adherence data in a clinical effectiveness trial. The salford lung study sls in asthma1 is a pioneering randomised controlled trial rct. 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. This difference means that subtle benefits from an improved inhaler or a oncedaily regimen could occur in an effectiveness study done in a routine care setting. A second salford lung study is ongoing in patients with asthma, with glaxosmithkline expecting to report results next year. Relvar is a combination of the inhaled corticosteroid ics, fluticasone furoate ff, and the longacting beta 2agonist laba, vilanterol vi ffvi. The salford lung study in chronic obstructive pulmonary disease sls copd was a 12month, phase iii, openlabel, randomised study comparing the effectiveness and safety of initiating oncedaily. The salford lung study protocol bmc pulmonary medicine. Sls asthma is the worlds first large prospective asthma effectiveness randomised controlled trial rct. In the usual care arm, the physician was free to choose the appropriate copd. 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 objective of the study was to compare the effectiveness and safety profile of ffvi 10025mcg with existing copd usual care. The salford lung study on copd was a large, randomized, comparative effectiveness trial conducted in a population that was intended to represent that seen in everyday clinical practice. The innovative realworld setting was a risk, but ultimately gsk. Salford lung study in asthma relvar ellipta fluticasone. The salford lung study is a phase 3 pragmatic randomized controlled trial conducted in a typical setting. Salford lung study for the conduct of an observational. Dec 15, 2017 henrik svedsater at glaxosmithkline in the uk, and coworkers, wanted to dig deeper into patient perceptions of copd during the salford lung study in chronic obstructive pulmonary disease sls. Salford lung study asthma results published northwest ehealth. I am coinvestigator of this observational study i have participated in advisory meetings with gsk, novonordisk, sanofi and novartis on pragmatic trials some of the slides were provided by gsk but contents of. The salford lung study sls asthma study howdata was captured challengeswith the data with examples conclusion rw01. Pioneering gsk study provides important new data on the effectiveness of relvar ellipta ffvi when used in everyday clinical practice.
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