Evidence map›Paper›PMID 23060624›Full record

Trial reportThe European respiratory journal2012

Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study.

Edward Kerwin, Jacques Hébert, Nicola Gallagher, Carmen Martin, Tim Overend, Vijay K T Alagappan, Yimeng Lu, Donald Banerji

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The European respiratory journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03084796 (A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI), which is not on this map. Cited by 89 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 13 pooled it
–field-weighted citation impact
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.

NCT03084796 phase2completednot on this mapstarted 2017, after this paper: background citation

A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (HFA Glycopyrronium Bromide Via Pressurized Metered Dose Inhaler) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled733ConditionsCOPD, Chronic Obstructive Pulmonary DiseaseArmsCHF 5259, Placebo, Tiotropium Bromide 18 µg Inhalation Capsule
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 13 syntheses or guidelines pooled it.

  1. Pooled it
  2. Efficacy and cardiovascular safety of LAMA in patients with COPD: a systematic review and meta-analysis.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021
    Pooled it
  3. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO.International journal of chronic obstructive pulmonary disease · 2021
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  9. Comparative efficacy of combination bronchodilator therapies in COPD: a network meta-analysis.International journal of chronic obstructive pulmonary disease · 2015
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  16. Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study.International journal of chronic obstructive pulmonary disease · 2017
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29 more citing papers are in PubMed but not listed here.

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

8 authors.

Edward KerwinClinical Research Institute of Southern Oregon, PC, Medford, OR, USA. ekerwin@allergyasthmaso.com
Jacques Hébert
Nicola Gallagher
Carmen Martin
Tim Overend
Vijay K T Alagappan
Yimeng Lu
Donald Banerji

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

NVA237 (glycopyrronium bromide) is a once-daily long-acting muscarinic antagonist (LAMA) in development for chronic obstructive pulmonary disease (COPD). The GLycopyrronium bromide in COPD airWays clinical Study 2 (GLOW2) evaluated the efficacy and safety of NVA237 in moderate-to-severe COPD over 52 weeks. Patients were randomised 2:1:1 to NVA237 50 μg, placebo or open-label tiotropium 18 μg for 52 weeks. Primary end-point was trough forced expiratory volume in 1 s (FEV(1)) at 12 weeks. 1,066 patients were randomised, 810 completed the study. At week 12, trough FEV(1) increased significantly by 97 mL with NVA237 (95% CI 64.6-130.2; p<0.001) and 83 mL with tiotropium (95% CI 45.6-121.4; p<0.001). Compared with placebo, NVA237 produced significant improvements in dyspnoea (Transition Dyspnoea Index at week 26; p=0.002) and health status (St George's Respiratory Questionnaire at week 52; p<0.001). NVA237 significantly reduced the risk of moderate-to-severe COPD exacerbations by 34% (p=0.001) and the use of rescue medication (p=0.039), versus placebo. NVA237-placebo and tiotropium-placebo differences were comparable for all outcomes. Safety profiles were similar across groups. NVA237 50 μg provided significant improvements in lung function, dyspnoea, health status, exacerbations and rescue medication use, versus placebo, and was comparable to tiotropium. NVA237 can potentially be an alternative choice of LAMA for COPD patients.

Indexed as

Bronchodilator AgentsDouble-Blind MethodFemaleGlycopyrrolateHumansMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveScopolamine DerivativesTiotropium BromideBronchodilator AgentsGlycopyrrolateMuscarinic AntagonistsScopolamine DerivativesTiotropium Bromide

Identifiers

PMID23060624
PMCPMC3485572

What OpenQuestion holds

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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.