Evidence map›Paper›PMID 30001712›Full record

Trial reportRespiratory research2018

Anti-inflammatory duration of action of fluticasone furoate/vilanterol trifenatate in asthma: a cross-over randomised controlled trial.

George Bardsley, Peter Daley-Yates, Amanda Baines, Rodger Kempsford, Mathew Williams, Tony Mallon, Irene Braithwaite, Kylie Riddell, Shashidhar Joshi, Philippe Bareille and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02712047 (A Randomised, Placebo-controlled, Double-blind, Two Period Crossover Study to Characterise the Exhaled Nitric Oxide Time Profile as a Biomarker of Airway Inflammation in Adult Asthma Patients Following Repeat Administration of Inhaled Fluticasone Furoate), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT02712047 phase2completednot on this map

A Randomised, Placebo-controlled, Double-blind, Two Period Crossover Study to Characterise the Exhaled Nitric Oxide Time Profile as a Biomarker of Airway Inflammation in Adult Asthma Patients Following Repeat Administration of Inhaled Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 mcg.

TypeinterventionalSponsorGlaxoSmithKlineRan2016 to 2017Enrolled28ConditionsAsthmaArmsFluticasone furoate (FF) (100 mcg), Vilanterol (VI) (25 mcg), Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Current appraisal of single inhaler triple therapy in COPD.International journal of chronic obstructive pulmonary disease · 2018
    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

13 authors at 3 institutions in 4 countries.

George BardsleyMedical Research Institute of New Zealand, Private Bag 7902, Newtown, Wellington, 6242, New Zealand.
Peter Daley-YatesRespiratory Clinical Development, GlaxoSmithKline Research and Development, Stockley Park, Uxbridge, UK.
Amanda BainesMedicines Development Centre, GlaxoSmithKline Research and Development, Stevenage, UK.
Rodger KempsfordMedicines Development Centre, GlaxoSmithKline Research and Development, Stevenage, UK.
Mathew WilliamsMedical Research Institute of New Zealand, Private Bag 7902, Newtown, Wellington, 6242, New Zealand.
Tony MallonMedical Research Institute of New Zealand, Private Bag 7902, Newtown, Wellington, 6242, New Zealand.
Irene BraithwaiteMedical Research Institute of New Zealand, Private Bag 7902, Newtown, Wellington, 6242, New Zealand.
Kylie RiddellGlaxoSmithKline Research and Development, 82 Hughes Ave, Ermington, NSW, 2115, Australia.
Shashidhar JoshiQuantitative sciences, GlaxoSmithKline, Bangalore, India.
Philippe BareilleMedicines Development Centre, GlaxoSmithKline Research and Development, Stevenage, UK.
Richard BeasleyMedical Research Institute of New Zealand, Private Bag 7902, Newtown, Wellington, 6242, New Zealand.
James FingletonMedical Research Institute of New Zealand, Private Bag 7902, Newtown, Wellington, 6242, New Zealand. james.fingleton@mrinz.ac.nz.ORCID 0000-0001-9148-196X
study team
GlaxoSmithKline (United Kingdom) · GBMedical Research Institute of New Zealand · NZGlaxoSmithKline (Australia) · AU

Funding

Health Research Council of New Zealand Independent Research Organisation funding
6 · The paper itself

Abstract

backgroundFluticasone furoate/Vilanterol trifenatate (FF/VI) is an inhaled corticosteroid/long-acting beta-agonist combination with a prolonged bronchodilator duration of action. We characterised the time-course of onset and offset of airway anti-inflammatory action of FF/VI, as assessed by fraction of exhaled nitric oxide (FeNO), and compared this to the bronchodilator duration of action.

methodsA single-centre, randomised, double-blind, placebo-controlled, two-period, crossover study was undertaken in 28 steroid-naïve adults with asthma. Participants with an FEV

resultsIn the 27 subjects who completed the study, median (range) baseline FeNO was 87 ppb (42-212). FF/VI 100/25 mcg reduced FeNO by day 3, ratio FF/VI versus placebo 0.72 (95% confidence interval 0.61-0.86) with the maximum reduction occurring at day 14, 0.32 (0.27-0.37). Following cessation of treatment FeNO remained suppressed for 18 days, ratio on day 18 0.77 (0.59-1.00), whereas improvements in FEV

conclusionsThe anti-inflammatory duration of action of FF/VI is consistent with the high glucocorticoid receptor affinity and long lung retention of fluticasone furoate. The anti-inflammatory effect of FF/VI was of greater duration than its bronchodilator effect in adults with mild asthma. Funding GlaxoSmithKline (201499).

trial registrationProspectively registered on ClinicalTrials.gov registry number NCT02712047 .

Indexed as

AdolescentAdultAndrostadienesAnti-Inflammatory AgentsAsthmaBenzyl AlcoholsChlorobenzenesCross-Over StudiesDouble-Blind MethodDrug CombinationsFemaleHumansMaleProspective StudiesYoung AdultAndrostadienesAnti-Inflammatory AgentsBenzyl AlcoholsChlorobenzenesDrug Combinationsfluticasone furoate-vilanterol trifenatateAsthmaClinical trialNitric oxide

Identifiers

PMID30001712
PMCPMC6044077
OpenAlexW2884905216

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.