Evidence map›Paper›PMID 26651333›Full record

Trial reportBMC pulmonary medicine2015

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma.

Ashley Woodcock, Nawar Diar Bakerly, John P New, J Martin Gibson, Wei Wu, Jørgen Vestbo, David Leather

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIPragmatic Clinical Trial
In one paragraph

Trial report in BMC pulmonary medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01706198 (A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01706198 phase3completednot on this map

A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler Compared With Usual Maintenance Therapy in Subjects With Asthma

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2016Enrolled4,233ConditionsAsthmaArmsfluticasone furoate + vilanterol, inhaled corticosteroid with or without a long acting beta2-agonist
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 51 citations in OpenAlex.

  1. Trial
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  3. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial.American journal of respiratory and critical care medicine · 2017
    Trial
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  15. Review
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  19. Using electronic health records for clinical trials: Where do we stand and where can we go?CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2019
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Ashley WoodcockInstitute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. ashley.woodcock@manchester.ac.uk.
Nawar Diar BakerlySalford Royal NHS Foundation Trust, Salford, UK. nawar.bakerly@srft.nhs.uk.
John P NewSalford Royal NHS Foundation Trust, Salford, UK. john.new@manchester.ac.uk.
J Martin GibsonSalford Royal NHS Foundation Trust, Salford, UK. Martin.Gibson@manchester.ac.uk.
Wei WuGlaxoSmithKline, Research Triangle Park, Durham, NC, USA. wei.w.wu@gsk.com.
Jørgen VestboInstitute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. jorgen.vestbo@manchester.ac.uk.
David LeatherGSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, UK. david.a.leather@gsk.com.
Salford Royal NHS Foundation Trust · GBUniversity of Manchester · GBGlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNovel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings. METHODS/

designThe Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors. PRIMARY ENDPOINT: Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data. DISCUSSION: The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings.

trial registrationClinicaltrials.gov, NCT01706198; 04 October 2012.

Indexed as

Clinical ProtocolsAdministration, InhalationAdultAndrostadienesAsthmaBenzyl AlcoholsChlorobenzenesDouble-Blind MethodGlucocorticoidsHumansMiddle AgedUnited KingdomAndrostadienesBenzyl AlcoholsChlorobenzenesfluticasone furoateGlucocorticoidsvilanterol

Identifiers

PMID26651333
PMCPMC4676141
OpenAlexW2191914671

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.