Evidence map›Paper›PMID 30621717›Full record

Trial reportRespiratory research2019

Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study.

Jadwiga A Wedzicha, Dave Singh, Ioanna Tsiligianni, Christine Jenkins, Sebastian Fucile, Robert Fogel, Steven Shen, Pankaj Goyal, Karen Mezzi, Konstantinos Kostikas

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2019. 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 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Just breathe: a review of sex and gender in chronic lung disease.European respiratory review : an official journal of the European Respiratory Society · 2022
    Review
  9. Review
  10. Women's COPD.Frontiers in medicine · 2021
    Review
  11. Review
  12. Article
  13. 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

10 authors at 7 institutions in 5 countries.

Jadwiga A WedzichaRespiratory Division, National Heart and Lung Institute, Imperial College London, London, UK. j.wedzicha@imperial.ac.uk.
Dave SinghDivision of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester, UK.
Ioanna TsiligianniDepartment of Social Medicine, Faculty of Medicine, University of Crete, Heraklion, Crete, Greece.
Christine JenkinsThe George Institute for Global Health, Sydney, Australia.
Sebastian FucileNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Robert FogelNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Steven ShenNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Pankaj GoyalNovartis Pharma AG, Basel, Switzerland.
Karen MezziNovartis Pharma AG, Basel, Switzerland.
Konstantinos KostikasRespiratory Medicine Department, University of Ioannina Medical School, Ioannina, Greece.
Novartis (United States) · USNovartis (Switzerland) · CHImperial College London · GBThe George Institute for Global Health · AUUniversity of Crete · GRUniversity of Ioannina · GRUniversity of Manchester · GB

Funding

Department of Health RP-PG-0109-10056Medical Research Council G0800570Medical Research Council G1001365Medical Research Council G1001372Novartis -
6 · The paper itself

Abstract

backgroundThe burden of chronic obstructive lung disease (COPD) is increasing in women, with recent evidence suggesting gender differences in disease characteristics and potentially in treatment outcomes.

methodsFLAME was a 52-week randomized controlled trial in patients with severe-to-very-severe COPD and a history of exacerbations. In this post-hoc analysis, gender-based baseline differences and treatment outcomes between indacaterol/glycopyrronium 110/50 μg once daily (IND/GLY) and salmeterol/fluticasone 50/500 twice daily (SFC) were assessed in terms of rate of exacerbations, time-to-first exacerbation, lung function, health status, and rescue medication use.

resultsThis post-hoc analysis included 2557 men and 805 women. Baseline characteristics differed between genders, with women being younger, having better lung function and more often experiencing ≥2 exacerbations in the previous year. Compared with SFC, IND/GLY treatment was associated with reductions in the annualized rates of moderate/severe exacerbations (rate ratio [95% CI]: 0.81 [0.73-0.91], 0.89 [0.74-1.07] in men and women, respectively). Similarly, time-to-first moderate/severe exacerbation was also delayed (hazard ratio [95% CI]: 0.79 [0.70-0.89] and 0.76 [0.63-0.91] in men and women, respectively). Results were similar for all (mild/moderate/severe) exacerbations. Improvements in lung function, health status and rescue medication use with IND/GLY vs SFC were comparable between men and women. The smaller sample size for women may account for some observed discrepancies in treatment responses.

conclusionsAlthough there were gender differences in baseline characteristics, IND/GLY demonstrated similar trends for exacerbation prevention and lung function improvement in men and women with moderate-to-very-severe COPD and a history of exacerbations compared with SFC. Small differences in the effects seen between genders may be attributed to the different sizes of the two groups and need to be further evaluated in randomized trials that are appropriately powered for gender analysis.

trial registrationPost hoc analysis of the FLAME study. ClinicalTrials.gov number: NCT01782326 . Registered 1 February 2013.

Indexed as

Sex CharacteristicsAgedBronchodilator AgentsDisease ProgressionDouble-Blind MethodDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationGlycopyrrolateHumansIndansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuinolonesTreatment OutcomeBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug CombinationGlycopyrrolateindacaterol-glycopyrronium combinationIndansQuinolonesChronic obstructive pulmonary diseaseExacerbation reductionGenderIndacaterol/glycopyrroniumLung function

Identifiers

PMID30621717
PMCPMC6325763
OpenAlexW2919030340

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.