Evidence map›Paper›PMID 23722616›Full record

Trial reportThe European respiratory journal2013

Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study.

Eric D Bateman, Gary T Ferguson, Neil Barnes, Nicola Gallagher, Yulia Green, Michelle Henley, Donald Banerji

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

Trial report in The European respiratory journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02812862 (Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD), which is not on this map. Cited by 191 papers, 32 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
191citing papers in PubMed, 32 pooled it
35.8field-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.

NCT02812862 phase4withdrawnnot on this mapstarted 2016, after this paper: background citation

Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD

TypeinterventionalSponsorRWTH Aachen UniversityRan2016 to 2018Enrolled0ConditionsCOPDArmsSpiolto® Respimat® (Tiotropium / Olodaterol)
3 · Its place in the literature

Who cites it

191 citing papers in PubMed, 32 syntheses or guidelines pooled it, 381 citations in OpenAlex.

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131 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 5 countries.

Eric D BatemanUniversity of Cape Town, Cape Town, South Africa.
Gary T Ferguson
Neil Barnes
Nicola Gallagher
Yulia Green
Michelle Henley
Donald Banerji
Novartis (France) · FRBarts Health NHS Trust · GBNovartis (Switzerland) · CHNovartis (United Kingdom) · GBPulmonary Associates · USUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We investigated the efficacy and safety of dual bronchodilation with QVA149 versus its monocomponents indacaterol and glycopyrronium, tiotropium and placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). This was a multicentre, randomised, double-blind, placebo- and active-controlled, 26-week trial. Patients (n = 2144) were randomised (2:2:2:2:1) to receive once-daily QVA149 (indacaterol 110 μg/glycopyrronium 50 μg), indacaterol 150 μg, glycopyrronium 50 μg, open-label tiotropium 18 μg or placebo. The primary end-point was trough forced expiratory volume in 1 s (FEV1) at week 26 for QVA149 versus its monocomponents. Secondary end-points included dyspnoea, health status, rescue medication use and safety. Trough FEV1 at week 26 was significantly improved (p<0.001) with QVA149 compared with indacaterol and glycopyrronium (least squares mean (LSM) differences 0.07 L and 0.09 L, respectively), tiotropium and placebo (LSM differences 0.08 L and 0.20 L, respectively); these beneficial effects were sustained throughout the 26-week study. QVA149 significantly improved dyspnoea and health status versus placebo (p<0.001 and p = 0.002, respectively) and tiotropium (p = 0.007 and p = 0.009, respectively) at week 26. All treatments were well tolerated. Dual bronchodilation with once-daily QVA149 demonstrated superior and clinically meaningful outcomes versus placebo and superiority versus treatment with a single bronchodilator, with a safety and tolerability profile similar to placebo, supporting the concept of fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist combinations for the treatment of COPD.

Indexed as

Administration, InhalationAdultAgedBronchodilator AgentsDouble-Blind MethodDrug CombinationsFemaleForced Expiratory VolumeGlycopyrrolateHumansIndansMaleMiddle AgedQuinolonesScopolamine DerivativesSpirometryBronchodilator AgentsDrug CombinationsGlycopyrrolateindacaterolindacaterol-glycopyrronium combinationIndansQuinolonesScopolamine DerivativesTiotropium Bromide

Identifiers

PMID23722616
PMCPMC3844137
OpenAlexW2142449488

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.