Evidence map›Paper›PMID 29762864›Full record

Trial reportJournal of clinical pharmacology2018

Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium/Vilanterol via a Single Inhaler in Patients with COPD.

Rashmi Mehta, Eleni Pefani, Misba Beerahee, Noushin Brealey, Helen Barnacle, Ruby Birk, Chang-Qing Zhu, David A Lipson

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 35% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. 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

8 authors at 4 institutions in 3 countries.

Rashmi MehtaGlaxoSmithKline, Research Triangle Park, NC, USA.
Eleni PefaniGlaxoSmithKline, Stevenage, Hertfordshire, UK.
Misba BeeraheeGlaxoSmithKline, Stevenage, Hertfordshire, UK.
Noushin BrealeyGlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, UK.
Helen BarnacleGlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, UK.
Ruby BirkGlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, UK.
Chang-Qing ZhuGlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, UK.
David A LipsonGlaxoSmithKline, King of Prussia, PA, USA.
GlaxoSmithKline (United Kingdom) · GBAge UK · GBGlaxoSmithKline (Japan) · JPGlaxoSmithKline (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A population pharmacokinetic analysis was conducted from a subset of samples obtained from the Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy trial to characterize the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol in patients with symptomatic COPD following treatment with fluticason furoate-umeclidinium-vilanterol combined in a single inhaler. This was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticason furoate-umeclidinium-vilanterol, 100 μg/62.5 μg/25 μg; Ellipta inhaler) with twice-daily dual therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). The analyses were conducted in a subset of 74 patients who received fluticason furoate-umeclidinium-vilanterol and provided serial or sparse samples. Monte Carlo simulations and a model-based estimation approach both indicated that systemic drug concentrations of fluticasone furoate, umeclidinium, and vilanterol after administration of fluticason furoate-umeclidinium-vilanterol triple combination therapy from a single inhaler were within the ranges observed following administration of these drugs as monotherapy (fluticasone furoate, umeclidinium, and vilanterol) or as dual-combination therapy (fluticasone furoate/vilanterol or umeclidinium/vilanterol).

Indexed as

Administration, InhalationAgedAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug CombinationsFemaleHumansMaleMiddle AgedMonte Carlo MethodNebulizers and VaporizersPulmonary Disease, Chronic ObstructiveQuality of LifeQuinuclidinesAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug Combinationsfluticasone furoateGSK573719QuinuclidinesvilanterolCOPDfluticasone furoatesingle-inhaler triple therapyumeclidiniumvilanterol

Identifiers

PMID29762864
PMCPMC6175098
OpenAlexW2885068495

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.