Evidence map›Paper›PMID 23846316›Full record

Trial reportChest2013

Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial.

Ashley Woodcock, Eugene R Bleecker, Jan Lötvall, Paul M O'Byrne, Eric D Bateman, Hilary Medley, Anna Ellsworth, Loretta Jacques, William W Busse

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Chest, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 5 pooled it
8.3field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Asthma and COPD: A Focus on β-Agonists - Past, Present and Future.Handbook of experimental pharmacology · 2024
    Review
  10. Review
  11. Observational
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Vilanterol and fluticasone furoate for asthma.The Cochrane database of systematic reviews · 2016
    Review
  19. Future treatment for asthma.European respiratory review : an official journal of the European Respiratory Society · 2016
    Article
  20. Review
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

9 authors at 8 institutions in 5 countries.

Ashley WoodcockInstitute of Inflammation and Repair, University of Manchester, University Hospital of South Manchester, Manchester, England. Electronic address: Ashley.woodcock@manchester.ac.uk.
Eugene R BleeckerCenter for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, NC.
Jan LötvallKrefting Research Centre, University of Gothenburg, Gothenburg, Sweden.
Paul M O'ByrneMichael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Eric D BatemanDepartment of Medicine, University of Cape Town, Cape Town, South Africa.
Hilary MedleyRespiratory Medicines Development Centre, GlaxoSmithKline, London, England.
Anna EllsworthQuantitative Sciences Division, GlaxoSmithKline, Research Triangle Park, NC.
Loretta JacquesRespiratory Medicines Development Centre, GlaxoSmithKline, London, England.
William W BusseDepartment of Medicine, University of Wisconsin-Madison, Madison, WI.
GlaxoSmithKline (United Kingdom) · GBMcMaster University · CAResearch Triangle Park Foundation · USSewanee: The University of the South · USUniversity of Cape Town · ZAUniversity of Gothenburg · SEUniversity of Wisconsin–Madison · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe combination of fluticasone furoate (FF), a novel inhaled corticosteroid (ICS), and vilanterol (VI), a long-acting β2 agonist, is under development as a once-daily treatment of asthma and COPD. The aim of this study was to compare the efficacy of FF/VI with fluticasone propionate (FP)/salmeterol (SAL) in patients with persistent asthma uncontrolled on a medium dose of ICS.

methodsIn a randomized, double-blind, double-dummy, parallel group study, 806 patients received FF/VI (100/25 μg, n = 403) once daily in the evening delivered through ELLIPTA (GlaxoSmithKline) dry powder inhaler, or FP/SAL (250/50 μg, n = 403) bid through DISKUS/ACCUHALER (GlaxoSmithKline). The primary efficacy measure was 0- to 24-h serial weighted mean (wm) FEV1 after 24 weeks of treatment.

resultsImprovements from baseline in 0- to 24-h wmFEV1 were observed with both FF/VI (341 mL) and FP/SAL (377 mL); the adjusted mean treatment difference was not statistically significant (-37 mL; 95% CI, -88 to 15, P = 0.162). There were no differences between 0- to 4-h serial wmFEV1, trough FEV1, and asthma control and quality-of-life questionnaire scores. There was no difference in reported exacerbations between treatments. Both treatments were well tolerated, with no clinically relevant effect on urinary cortisol excretion or vital signs and no treatment-related serious adverse events.

conclusionsThe efficacy of once-daily FF/VI was similar to bid FP/SAL in improving lung function in patients with persistent asthma. No safety issues were identified.

Indexed as

AdolescentAdultAgedAged, 80 and overAlbuterolAndrostadienesAsthmaBenzyl AlcoholsChildChlorobenzenesDouble-Blind MethodDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationHumansMaleAlbuterolAndrostadienesBenzyl AlcoholsChlorobenzenesDrug Combinationsfluticasone furoateFluticasone-Salmeterol Drug Combinationvilanterol

Identifiers

PMID23846316
PMCPMC3787916
OpenAlexW1996099244

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.