Evidence map›Paper›PMID 28993871›Full record

Trial reportLung2017

Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies.

Edward Kerwin, Gary T Ferguson, Shahin Sanjar, Thomas Goodin, Anthony Yadao, Robert Fogel, Samopriyo Maitra, Biswajit Sen, Tim Ayers, Donald Banerji

2 registry-linked trialsAbstract readComparative StudyEquivalence TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lung, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 6 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT02487446 phase3completednot on this map

A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2016Enrolled357ConditionsChronic Obstructive Pulmonary DiseaseArmsQVA149, Umeclidinium/vilanterol, Placebo (umeclidinium/vilanterol), Placebo (QVA149)
NCT02487498 phase3completednot on this map

A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, Two-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation.

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2016Enrolled355ConditionsChronic Obstructive Pulmonary DiseaseArmsQVA149, Umeclidinium/vilanterol, Placebo (umeclidinium/vilanterol ), Placebo (QVA149)
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 6 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Joint longitudinal model-based meta-analysis of FEVJournal of pharmacokinetics and pharmacodynamics · 2023
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Article
  8. Future concepts in bronchodilation for COPD: dual-European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  9. Article
  10. Observational
  11. COPD from an everyday primary care point of view.Journal of family medicine and primary care · 2019
    Article
  12. Single Inhaler LABA/LAMA for COPD.Frontiers in pharmacology · 2019
    Article
  13. Review
  14. Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.International journal of chronic obstructive pulmonary disease · 2019
    Review
  15. Review
  16. Inhaled glycopyrrolate for the treatment of chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2018
    Review
  17. Review
  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

10 authors at 4 institutions in 2 countries.

Edward KerwinClinical Research Institute, Medford, OR, USA.
Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Shahin SanjarSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA.
Thomas GoodinSunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA.
Anthony YadaoNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Robert FogelNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Samopriyo MaitraNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Biswajit SenNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Tim AyersNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Donald BanerjiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA. donald.banerji@novartis.com.
Novartis (United States) · USNovartis (India) · INSunovion (United States) · USClinical Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI).

methodsStudies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62.5/25 μg, each separated by a 3-week washout. The primary objective was to demonstrate non-inferiority of IND/GLY compared with UMEC/VI in terms of the 24-h forced expiratory volume in 1 s profile at week 12 (FEV

resultsBoth treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV

conclusionsIND/GLY and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant. The data support the use of IND/GLY as an efficacious and well tolerated treatment option in patients with COPD. (ClinicalTrials.gov NCT02487446 and NCT02487498).

Indexed as

AgedBenzyl AlcoholsBronchodilator AgentsChlorobenzenesCross-Over StudiesDouble-Blind MethodDrug CombinationsFemaleForced Expiratory VolumeGlycopyrrolateHumansIndansMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug CombinationsGlycopyrrolateGSK573719indacaterol-glycopyrronium combinationIndansMuscarinic AntagonistsQuinolonesQuinuclidinesvilanterolCOPDIndacaterol/glycopyrrolateLong-acting muscarinic antagonistLong-acting β2-agonistsNon-inferiority trialUmeclidinium/vilanterol

Identifiers

PMID28993871
OpenAlexW2763746332

What OpenQuestion holds

Textmetadata
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.