Evidence map›Paper›PMID 24136330›Full record

Trial reportThe European respiratory journal2014

Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma.

Paul M O'Byrne, Eugene R Bleecker, Eric D Bateman, William W Busse, Ashley Woodcock, Richard Forth, William T Toler, Loretta Jacques, Jan Lötvall

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The European respiratory journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
8.1field-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

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Development of Inhaled GABAACS pharmacology & translational science · 2022
    Article
  13. Article
  14. Review
  15. Article
  16. Vilanterol and fluticasone furoate for asthma.The Cochrane database of systematic reviews · 2016
    Review
  17. Review
  18. Article
  19. Review
  20. Striving for optimal bronchodilation: focus on olodaterol.International journal of chronic obstructive pulmonary disease · 2016
    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 7 countries.

Paul M O'ByrneHamilton, ON, Canada.
Eugene R Bleecker
Eric D Bateman
William W Busse
Ashley Woodcock
Richard Forth
William T Toler
Loretta Jacques
Jan Lötvall
Research Triangle Park Foundation · USGlaxoSmithKline (United Kingdom) · GBHamilton Health Sciences · CAUniversity of Cape Town · ZAUniversity of Gothenburg · SEUniversity of Manchester · GBUniversity of Wisconsin–Madison · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The inhaled corticosteroid fluticasone furoate (FF) and the long-acting β₂ agonist vilanterol (VI) are in development as a combined once-daily therapy for asthma and chronic obstructive pulmonary disease. Our study objectives were to compare the efficacy and safety of once-daily FF/VI with FF alone and twice-daily fluticasone propionate (FP) in patients aged ≥12 years with moderate-to-severe persistent asthma. Patients (n=586) received FF/VI 200/25 μg or FF 200 μg once-daily (evening dosing), or FP 500 μg twice-daily for 24 weeks. Co-primary end-points were change from baseline in trough forced expiratory volume in 1 s (FEV₁) weighted mean (wm) 0-24 h serial FEV1. Secondary end-points included change from baseline in percentage of rescue-free 24-h periods, percentage of symptom-free 24-h periods and total Asthma Quality of Life Questionnaire (AQLQ). Safety assessments included adverse events, 24-h urinary cortisol excretion, vital signs and ECG. FF/VI significantly improved trough FEV1 and wmFEV₁ versus FF and FP. Significantly more rescue-free and symptom-free 24-h periods were reported with FF/VI versus FF. Treatment differences for AQLQ were not significant. Incidence of adverse events was similar across groups. No clinically significant differences were seen for 24-h urinary cortisol excretion, vital signs or ECG. FF/VI resulted in statistically greater improvements in lung function and symptomatic end-points versus FF, and was well tolerated in this asthma population.

Indexed as

AdultAndrostadienesAnti-Asthmatic AgentsAsthmaBenzyl AlcoholsChlorobenzenesDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationElectrocardiographyFemaleForced Expiratory VolumeGlucocorticoidsHumansHydrocortisoneMaleAndrostadienesAnti-Asthmatic AgentsBenzyl AlcoholsChlorobenzenesfluticasone furoateGlucocorticoidsHydrocortisonevilanterol

Identifiers

PMID24136330
PMCPMC3938760
OpenAlexW2118866729

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.