Evidence map›Paper›PMID 29692607›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Exacerbation heterogeneity in COPD: subgroup analyses from the FLAME study.

Claus F Vogelmeier, Kenneth R Chapman, Marc Miravitlles, Nicolas Roche, Jørgen Vestbo, Chau Thach, Donald Banerji, Robert Fogel, Francesco Patalano, Petter Olsson and 2 more

Open access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. 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

12 authors at 9 institutions in 8 countries.

Claus F VogelmeierMember of the German Center for Lung Research (DZL), Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Marburg, Germany.
Kenneth R ChapmanAsthma and Airway Centre, University Health Network and University of Toronto, Toronto, ON, Canada.
Marc MiravitllesPneumology Department, Hospital Universitari Vall d'Hebron, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
Nicolas RocheService de Pneumologie AP-HP, Cochin Hospital, University Paris Descartes (EA2511), Paris, France.
Jørgen VestboInstitute of Infection, Immunity and Respiratory Medicine, The University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.
Chau ThachNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Donald BanerjiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Robert FogelNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Francesco PatalanoNovartis Pharma AG, Basel, Switzerland.
Petter OlssonNovartis Sverige AB, Täby, Sweden.
Konstantinos KostikasNovartis Pharma AG, Basel, Switzerland.
Jadwiga A WedzichaNational Heart and Lung Institute, Imperial College London, London, UK.
Novartis (United States) · USNovartis (Switzerland) · CHCentro de Investigación Biomédica en Red de Enfermedades Respiratorias · ESDélégation Paris 5 · FRImperial College London · GBManchester University NHS Foundation Trust · GBNovartis (Sweden) · SEPhilipps University of Marburg · DEUniversity Health Network · CA

Funding

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

Abstract

backgroundThe FLAME study compared once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 μg with twice-daily salmeterol/fluticasone (SFC) 50/500 μg in symptomatic patients with moderate to very severe COPD and a history of exacerbations in the previous year.

methodsThis prespecified and post hoc subgroup analysis evaluated treatment efficacy on 1) moderate/severe exacerbations according to prior exacerbation history and treatment, and 2) types of exacerbations according to health care resource utilization (HCRU) during 1-year follow-up.

resultsIND/GLY reduced the rate of moderate/severe exacerbations versus SFC in patients with a history of 1 exacerbation (rate ratio [RR]: 0.83, 95% CI: 0.75-0.93), ≥2 exacerbations (RR: 0.85, 95% CI: 0.70-1.03) and ≥2 exacerbations or ≥1 hospitalization in the previous year (RR: 0.86, 95% CI: 0.74-1.00). Prolonged time-to-first exacerbation was observed in all the groups according to exacerbation history. Moderate/severe exacerbations decreased with IND/GLY versus SFC, independent of previous treatment. IND/GLY significantly reduced rates of moderate/severe exacerbations treated with antibiotics (RR: 0.79, 95% CI: 0.67-0.93) and systemic corticosteroids and antibiotics (RR: 0.80, 95% CI: 0.70-0.91); rates of exacerbations treated with systemic corticosteroids alone were comparable (RR: 0.99, 95% CI: 0.80-1.22).

conclusionOverall, IND/GLY demonstrated consistent beneficial effects versus SFC on moderate/severe exacerbations, independent of prior exacerbation history or treatment. The efficacy of IND/GLY on exacerbation prevention was superior to SFC for exacerbations treated with antibiotics with/without systemic corticosteroids and was similar for exacerbations treated with systemic corticosteroids alone.

Indexed as

Adrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAgedBronchodilator AgentsDisease ProgressionDouble-Blind MethodDrug Administration ScheduleDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationForced Expiratory VolumeGlycopyrrolateHospitalizationHumansIndansKaplan-Meier EstimateAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug CombinationGlycopyrrolateindacaterol-glycopyrronium combinationIndansMuscarinic AntagonistsQuinolonesindacaterol/glycopyrroniumLABA/ICSLABA/LAMAsalmeterol/fluticasone

Identifiers

PMID29692607
PMCPMC5901128
OpenAlexW2797099929

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.