Evidence map›Paper›PMID 25841237›Full record

Trial reportThorax2015

Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.

Peter A Frith, Philip J Thompson, Rajeev Ratnavadivel, Catherina L Chang, Peter Bremner, Peter Day, Christina Frenzel, Nicol Kurstjens, Glisten Study Group

4 registry-linked trialsOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thorax, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 36 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 7 pooled it
12.9field-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.

NCT01513460 phase3completednot on this map

A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2013Enrolled773ConditionsChronic Obstructive Pulmonary DiseaseArmsNVA237 50µg once daily, Tiotropium 18µg once daily, Flu/Sal, NVA237 placebo + Tiotropium placebo.
NCT03084718 phase2completednot on this mapstarted 2017, after this paper: background citation

An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled610ConditionsAsthmaArmsCHF 718 pMDI, Placebo pMDI, Beclomethasone Dipropionate (BDP)
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
NCT03086460 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomized, Double-blind, Placebo and Active-controlled, Incomplete Block Cross-over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled67ConditionsAsthmaArmsCHF 1531 pMDI, Formoterol Inhalation Solution, Placebo pMDI
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 7 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Pooled it
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  11. A randomized trial of symptom-based management in Japanese patients with COPD.International journal of chronic obstructive pulmonary disease · 2018
    Trial
  12. Trial
  13. Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study.International journal of chronic obstructive pulmonary disease · 2017
    Trial
  14. Trial
  15. Effect of background long-acting betaInternational journal of chronic obstructive pulmonary disease
    Trial
  16. Article
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  19. Real-World Experience of Treating Chronic Obstructive Pulmonary Disease with Triple Therapy.International journal of chronic obstructive pulmonary disease · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 2 countries.

Peter A FrithRespiratory Clinical Research Unit, Repatriation General Hospital, Adelaide, South Australia, Australia.
Philip J ThompsonThe Lung Health Clinic, Centre for Asthma Allergy and Respiratory Research, University of Western Australia, and the Lung Institute of Western Australia, Perth, Western Australia, Australia.
Rajeev RatnavadivelDepartment of Respiratory Medicine, Gosford Hospital, Gosford, New South Wales, Australia.
Catherina L ChangDepartment of Respiratory and Sleep Medicine, Waikato Hospital, Hamilton, New Zealand.
Peter BremnerSt John of God Hospital, Murdoch, Western Australia, Australia.
Peter DayMedical Centre, Redcliffe Peninsula 7 Day Medical Centre, Brisbane, Queensland, Australia.
Christina FrenzelClinical Development and Medical Affairs, Novartis Pharmaceuticals Australia Pty Limited, Sydney, New South Wales, Australia.
Nicol KurstjensClinical Development and Medical Affairs, Novartis Pharmaceuticals Australia Pty Limited, Sydney, New South Wales, Australia.
Glisten Study Group
Novartis (Australia) · AUGosford Hospital · AURedcliffe Hospital · AURepatriation General Hospital · AUSt John of God Murdoch Hospital · AUThe University of Western Australia · AUWaikato Hospital · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease (COPD) is unclear. The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists (LAMA), when combined with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA).

methodsThis randomised, blinded, placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium (GLY) 50 µg, once-daily tiotropium (TIO) 18 µg or placebo (PLA), when combined with salmeterol/fluticasone propionate (SAL/FP) 50/500 µg twice daily. The primary objective was to determine the non-inferiority of GLY+SAL/FP versus TIO+SAL/FP on trough FEV1 after 12 weeks. An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone.

results773 patients (mean FEV1 57.2% predicted) were randomised; 84.9% completed the trial. At week 12, GLY+SAL/FP demonstrated non-inferiority to TIO+SAL/FP for trough FEV1: least square mean treatment difference (LSMdiff) -7 mL (SE 17.4) with a lower limit for non-inferiority of -60 mL. There was significant increase in week 12 trough FEV1 with GLY+SAL/FP versus PLA+SAL/FP (LSMdiff 101 mL, p<0.001). At 12 weeks, GLY+SAL/FP produced significant improvement in St George's Respiratory Questionnaire total score versus PLA+SAL/FP (LSMdiff -2.154, p=0.02). GLY+SAL/FP demonstrated significant rescue medication reduction versus PLA+SAL/FP (LSMdiff -0.72 puffs/day, p<0.001). Serious adverse events were similar for GLY+SAL/FP, TIO+SAL/FP and PLA+SAL/FP with an incidence of 5.8%, 8.5% and 5.8%, respectively.

conclusionsGLY+SAL/FP showed comparable improvements in lung function, health status and rescue medication to TIO+SAL/FP. Importantly, addition of GLY to SAL/FP demonstrated significant improvements in lung function, health status and rescue medication compared to SAL/FP. TRIAL REGISTRATION NUMBER: NCT01513460.

Indexed as

Administration, InhalationAgedAlbuterolAndrostadienesAustraliaBronchodilator AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleFluticasoneForced Expiratory VolumeGlycopyrrolateHealth StatusHumansAlbuterolAndrostadienesBronchodilator AgentsFluticasoneGlycopyrrolateSalmeterol XinafoateScopolamine DerivativesTiotropium BromideCOPD Pharmacology

Identifiers

PMID25841237
PMCPMC4453631
OpenAlexW2159477321

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.