Evidence map›Paper›PMID 29925383›Full record

Trial reportRespiratory research2018

Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study.

Antonio R Anzueto, Konstantinos Kostikas, Karen Mezzi, Steven Shen, Michael Larbig, Francesco Patalano, Robert Fogel, Donald Banerji, Jadwiga A Wedzicha

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
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 NCT01782326 (A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT01782326 phase3completednot on this map

A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2015Enrolled3,362ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsQVA149, Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. International journal of molecular sciences · 2025
    Trial
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  11. Article
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  15. Future concepts in bronchodilation for COPD: dual-European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  16. Review
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  18. Review
  19. 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 4 institutions in 3 countries.

Antonio R AnzuetoUniversity of Texas Health Science Center and South Texas Veterans Healthcare System, University of Texas, San Antonio, TX, USA. anzueto@uthscsa.edu.
Konstantinos KostikasNovartis Pharma AG, Basel, Switzerland.
Karen MezziNovartis Pharma AG, Basel, Switzerland.
Steven ShenNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Michael LarbigNovartis Pharma AG, Basel, Switzerland.
Francesco PatalanoNovartis Pharma AG, Basel, Switzerland.
Robert FogelNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Donald BanerjiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Jadwiga A WedzichaRespiratory Clinical Science, National Heart and Lung Institute, Imperial College London, London, UK.
Novartis (Switzerland) · CHNovartis (United States) · USImperial College London · GBThe University of Texas Health Science Center at San Antonio · US

Funding

Department of Health RP-PG-0109-10056Medical Research Council G0800570Medical Research Council G1001365Medical Research Council G1001372
6 · The paper itself

Abstract

backgroundChronic obstructive pulmonary disease (COPD) is a progressive disease and a composite endpoint could be an indicator of treatment effect on disease worsening. This post-hoc analysis assessed whether indacaterol/glycopyrronium (IND/GLY) 110/50 μg once daily reduced the risk of clinically important deterioration (CID) versus salmeterol/fluticasone (SFC) 50/500 μg twice daily in moderate-to-very severe COPD patients from the FLAME study.

methodsCID was defined as ≥100 mL decrease in forced expiratory volume in 1 s (FEV

resultsIND/GLY significantly delayed the time to CID (hazard ratio [HR] (95% confidence interval [CI]), 0.72 [0.67-0.78]; P < 0.0001), and reduced the incidences of CID versus SFC. Additionally, IND/GLY delayed the time to CID in all patient subgroups. After 12 weeks until 52 weeks, CID+ patients had a significantly higher rate of moderate-to-severe exacerbations versus CID- patients (P < 0.0001); moreover, CID+ patients experienced moderate-to-severe exacerbations significantly earlier versus CID- patients (P < 0.0001). CID+ patients had a comparable change in the SGRQ total score versus CID- patients.

conclusionsIND/GLY reduced the risk of CID versus SFC. CID had a significant impact on long-term exacerbation outcomes in patients with moderate-to-very severe COPD and a history of ≥1 exacerbations in the previous year.

trial registrationClinicaltrials.gov NCT01782326 .

Indexed as

Disease ProgressionAgedBronchodilator AgentsDouble-Blind MethodDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationGlycopyrrolateHumansIndansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuinolonesBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug CombinationGlycopyrrolateindacaterol-glycopyrronium combinationIndansQuinolonesChronic obstructive pulmonary diseaseCIDClinically important deteriorationCOPDFLAMEIndacaterol/glycopyrroniumLABA/LAMASalmeterol/fluticasone

Identifiers

PMID29925383
PMCPMC6011394
OpenAlexW2809579464

What OpenQuestion holds

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LicenceCC BY
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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.