Evidence map›Paper›PMID 28875459›Full record

ArticleAdvances in therapy2017

Once-Daily Triple Therapy in Patients with Advanced COPD: Healthcare Resource Utilization Data and Associated Costs from the FULFIL Trial.

Afisi S Ismaila, Ruby Birk, Dhvani Shah, Shiyuan Zhang, Noushin Brealey, Nancy A Risebrough, Maggie Tabberer, Chang-Qing Zhu, David A Lipson

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02345161 (A Phase III, 24 Week, Randomized, Double Blind, Double Dummy, Parallel Group Study), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% 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.

NCT02345161 phase3completednot on this map

A Phase III, 24 Week, Randomized, Double Blind, Double Dummy, Parallel Group Study (With an Extension to 52 Weeks in a Subset of Subjects) Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in the Morning Via a Dry Powder Inhaler With Budesonide/Formoterol 400mcg/12mcg Administered Twice-Daily Via a Reservoir Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2016Enrolled1,811ConditionsPulmonary Disease, Chronic ObstructiveArmsTriple FF/UMEC/VI, Placebo to match FF/UMEC/VI, Budesonide/Formoterol, Placebo to match Budesonide/Formoterol combination, Albuterol/salbutamol
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Effect of triple therapy in patients with asthma-COPD overlap
.International journal of clinical pharmacology and therapeutics · 2019
    Trial
  5. Article
  6. Article
  7. Article
  8. A Delphi Consensus Document on the Use of Single-Inhaler Fixed-Dose Triple Therapies in COPD Patients.International journal of chronic obstructive pulmonary disease · 2020
    Article
  9. Observational
  10. Review
  11. 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 4 institutions in 2 countries.

Afisi S IsmailaValue Evidence and Outcomes, GSK, Research Triangle Park, NC, USA. afisi.s.ismaila@gsk.com.
Ruby BirkRespiratory Clinical Development, GSK, Stockley Park, Uxbridge, UK.
Dhvani ShahICON Health Economics, ICON, New York, NY, USA.
Shiyuan ZhangRespiratory Research and Development, GSK, Collegeville, PA, USA.
Noushin BrealeyRespiratory Clinical Development, GSK, Stockley Park, Uxbridge, UK.
Nancy A RisebroughICON Health Economics, ICON, Toronto, ON, Canada.
Maggie TabbererValue Evidence and Outcomes, GSK, Stockley Park, Uxbridge, UK.
Chang-Qing ZhuRespiratory Clinical Development, GSK, Stockley Park, Uxbridge, UK.
David A LipsonRespiratory Research and Development, GSK, King of Prussia, PA, USA.
GlaxoSmithKline (United States) · USHealth Economics and Outcomes Research (United Kingdom) · GBResearch Triangle Park Foundation · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62.5 µg/25 µg or twice-daily dual inhaled corticosteroid/long-acting beta agonist therapy (budesonide/formoterol) 400 µg/12 µg.

methodsFULFIL was a phase III, randomized, double-blind, double-dummy, multicenter study. Unscheduled contacts with healthcare providers were recorded by patients in a daily electronic diary; the costs of healthcare resource utilization were calculated post hoc using UK reference costs.

resultsOver 24 weeks, slightly fewer patients who received fluticasone furoate/umeclidinium/vilanterol (169/911; 18.6%) required contacts with healthcare providers compared with budesonide/formoterol (180/899; 20.0%). Over 52 weeks in an extension population, fewer patients who received fluticasone furoate/umeclidinium/vilanterol required unscheduled contacts with healthcare providers compared with budesonide/formoterol (25.2% vs. 32.7%). Non-drug costs per treated patient per year were lower in the fluticasone furoate/umeclidinium/vilanterol group than the budesonide/formoterol group over 24 and 52 weeks (£653.80 vs. £763.32 and £749.22 vs. £988.03, respectively), with the total annualized cost over 24 weeks being slightly greater for fluticasone furoate/umeclidinium/vilanterol than budesonide/formoterol (£1,289.35 vs. £1,267.45).

conclusionsThis healthcare resource utilization evidence suggests that, in a clinical trial setting over a 24- or 52-week timeframe, non-drug costs associated with management of a single inhaler fluticasone furoate/umeclidinium/vilanterol are lower compared with twice-daily budesonide/formoterol.

trial registrationClinicalTrials.gov number: NCT02345161.

fundingGSK.

Indexed as

Adrenal Cortex HormonesAdultAgedAged, 80 and overAndrostadienesBronchodilator AgentsBudesonideDouble-Blind MethodFemaleFormoterol FumarateHumansMaleMiddle AgedNebulizers and VaporizersPulmonary Disease, Chronic ObstructiveUnited KingdomAdrenal Cortex HormonesAndrostadienesBronchodilator AgentsBudesonidefluticasone furoateFormoterol FumarateBudesonide/formoterolCOPD burdenCost analysesFluticasone furoate/umeclidinium/vilanterolRandomized controlled trialsSingle inhaler triple therapyTrial-based healthcare resource utilization

Identifiers

PMID28875459
PMCPMC5599456
OpenAlexW2752535758

What OpenQuestion holds

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LicenceCC BY-NC
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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.