Evidence map›Paper›PMID 25677679›Full record

Trial reportThorax2015

Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study.

Roland Buhl, Christian Gessner, Wolfgang Schuermann, Karin Foerster, Christian Sieder, Simone Hiltl, Stephanie Korn

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
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 trial NCT01120717 (A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149), which is not on this map. Cited by 24 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 7 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT01120717 phase3completednot on this map

A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2010 to 2011Enrolled339ConditionsChronic Obstructive Pulmonary DiseaseArmsQVA149, Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 7 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. What conservative interventions can improve the long-term quality of life, depression, and anxiety of individuals with stable COPD? A systematic review and meta-analysis.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients.International journal of chronic obstructive pulmonary disease · 2020
    Trial
  9. Trial
  10. Article
  11. INTREPID: single-ERJ open research · 2021
    Article
  12. Observational
  13. Review
  14. Inhaled glycopyrrolate for the treatment of chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2018
    Review
  15. Dual bronchodilation vs triple therapy in the "real-life" COPD DACCORD study.International journal of chronic obstructive pulmonary disease · 2018
    Observational
  16. Toward effective prescription of inhaled corticosteroids in chronic airway disease.International journal of chronic obstructive pulmonary disease · 2018
    Article
  17. Article
  18. Maintenance therapy in COPD: time to phase out ICS and switch to the new LAMA/LABA inhalers?International journal of chronic obstructive pulmonary disease · 2017
    Review
  19. Impact and prevention of severe exacerbations of COPD: a review of the evidence.International journal of chronic obstructive pulmonary disease · 2017
    Review
  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

7 authors at 5 institutions in 1 country.

Roland BuhlIII.Medizinische Klinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz K.d.ö.R., Mainz, Germany.
Christian GessnerUniversitätsklinikum Leipzig, Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany.
Wolfgang SchuermannPneumologische Praxis, Marburg, Germany.
Karin FoersterKardio-Pneumologische Praxis, Berlin, Germany.
Christian SiederNovartis Pharma GmbH, Nürnberg, Germany.
Simone HiltlNovartis Pharma GmbH, Nürnberg, Germany.
Stephanie KornUniversitätsmedizin der Johannes Gutenberg-Universität, Mainz, Germany.
Novartis (Germany) · DEOrthopädische Praxis · DEJohannes Gutenberg University Mainz · DEUniversity Hospital Leipzig · DEUniversity Medical Center of the Johannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQVA149 is a once-daily (o.d.) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD. The QUANTIFY study compared QVA149 with a free-dose bronchodilator combination of tiotropium plus formoterol (TIO+FOR) in improving health-related quality of life (HRQoL) of patients with COPD.

methodsThis multicentre, blinded, triple-dummy, parallel-group, non-inferiority study randomised patients aged ≥40 years with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 s (FEV1) ≥30% to <80% predicted) to QVA149 110/50 µg o.d. or TIO 18 µg o.d.+ FOR 12 µg twice daily (1:1) for 26 weeks. The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George's Respiratory Questionnaire-COPD (SGRQ-C). The prespecified non-inferiority margin was 4 units. Secondary endpoints included Transition Dyspnoea Index (TDI) score, pre-dose FEV1, forced vital capacity (FVC) and safety.

resultsOf the 934 patients randomised (QVA149=476 and TIO+FOR=458), 87.9% completed the study. At week 26, non-inferiority was met for SGRQ-C (QVA149 vs TIO+FOR; difference: -0.69 units; 95% CI -2.31 to 0.92; p=0.399). A significantly higher percentage of patients achieved a clinically relevant ≥1 point improvement in TDI total score with QVA149 (49.6%) versus TIO+FOR (42.4%; p=0.033). QVA149 significantly increased pre-dose FEV1 (+68 mL, 95% CI 37 mL to 100 mL; p<0.001) and FVC (+74 mL, 95% CI 24 mL to 125 mL; p=0.004) compared with TIO+FOR at week 26. The incidence of adverse events was comparable between both treatments (QVA149=43.7% and TIO+FOR=42.6%).

conclusionsQVA149 is non-inferior to TIO+FOR in improving HRQoL, with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD. TRIAL REGISTRATION NUMBER: NCT01120717.

Indexed as

Adrenergic beta-2 Receptor AgonistsAgedBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleDrug CombinationsEthanolaminesFemaleForced Expiratory VolumeFormoterol FumarateGlycopyrrolateHumansIndansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsEthanolaminesFormoterol FumarateGlycopyrrolateindacaterol-glycopyrronium combinationIndansQuinolonesScopolamine DerivativesTiotropium BromideCOPD Pharmacology

Identifiers

PMID25677679
PMCPMC4392202
OpenAlexW2162430901

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.