Evidence map›Paper›PMID 24596459›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2014

Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study.

Walter Vincken, Joseph Aumann, Hungta Chen, Michelle Henley, Danny McBryan, Pankaj Goyal

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 5 pooled it
11.1field-weighted citation impact, top 1% 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

30 citing papers in PubMed, 5 syntheses or guidelines pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Role of combined indacaterol and glycopyrronium bromide (QVA149) for the treatment of COPD in Japan.International journal of chronic obstructive pulmonary disease · 2015
    Pooled it
  6. Trial
  7. Lung Hyperinflation as Treatable Trait in Chronic Obstructive Pulmonary Disease: A Narrative Review.International journal of chronic obstructive pulmonary disease · 2024
    Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. When is dual bronchodilation indicated in COPD?International journal of chronic obstructive pulmonary disease · 2017
    Review
  15. LABA/LAMA combination in COPD: a meta-analysis on the duration of treatment.European respiratory review : an official journal of the European Respiratory Society · 2017
    Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Strategies for reducing the risk of cardiovascular disease in patients with chronic obstructive pulmonary disease.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2015
    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

6 authors at 2 institutions in 2 countries.

Walter VinckenRespiratory Division, University Hospital, UZ Brussel, Free University of Brussels, Brussels, Belgium.
Joseph AumannLongartsenpraktijk, Prins Bisschopssingel, Hasselt, Belgium.
Hungta ChenNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Michelle HenleyNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Danny McBryanNovartis Pharma AG, Basel, Switzerland.
Pankaj GoyalNovartis Pharma AG, Basel, Switzerland.
Novartis (Switzerland) · CHTris Pharma (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAddition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) whose symptoms are insufficiently controlled by bronchodilator monotherapy. GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) versus IND alone in patients with moderate-to-severe COPD. MATERIALS AND

methodsIn this randomized, double-blind, parallel group, placebo-controlled, 12-week study, patients were randomized 1:1 to IND 150 μg and GLY 50 μg daily (IND + GLY) or IND 150 μg daily and placebo (IND + PBO) (all delivered via separate Breezhaler® devices). The primary objective was to demonstrate the superiority of IND + GLY versus IND + PBO for trough forced expiratory volume in 1 second (FEV1) at week 12. Other end points included trough FEV1 at day 1, FEV1 area under the curve from 30 minutes to 4 hours (AUC30min-4h), peak FEV1, inspiratory capacity and trough forced vital capacity (FVC) at day 1 and week 12, and transition dyspnea index (TDI) focal score, COPD symptoms, and rescue medication use over 12 weeks.

resultsA total of 449 patients were randomized (IND + GLY, 226; IND + PBO, 223); 94% completed the study. On day 1 and at week 12, IND + GLY significantly improved trough FEV1 versus IND + PBO, with treatment differences of 74 mL (95% CI 46-101 mL) and 64 mL (95% CI 28-99 mL), respectively (both P<0.001). IND + GLY significantly improved postdose peak FEV1, FEV1 AUC30min-4h, and trough FVC at day 1 and week 12 versus IND + PBO (all P<0.01). TDI focal score and COPD symptoms (percentage of days able to perform usual daily activities and change from baseline in mean daytime respiratory score) were significantly improved with IND + GLY versus IND + PBO (P<0.05). The incidence of adverse events was similar for the two treatment groups.

conclusionIn patients with moderate-to-severe COPD, once-daily coadministration of IND and GLY provides significant and sustained improvement in bronchodilation versus IND alone from day 1, with significant improvements in patient-centered outcomes.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedArea Under CurveBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationEuropeFemaleForced Expiratory VolumeGlycopyrrolateHumansIndansInspiratory CapacityLungAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsGlycopyrrolateindacaterolIndansMuscarinic AntagonistsQuinolonesBreezhaler®bronchodilationCOPDglycopyrroniumindacaterolinhalation therapy

Identifiers

PMID24596459
PMCPMC3940646
OpenAlexW2086342579

What OpenQuestion holds

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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.