Evidence map›Paper›PMID 24159259›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2013

Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study.

Ronald Dahl, Dalal Jadayel, Vijay K T Alagappan, Hungta Chen, Donald Banerji

Erratum issuedOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 8 pooled it
7.2field-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.

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

26 citing papers in PubMed, 8 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Race-Based Pulmonary Function Testing Correction in COPD Inhaler Therapy Trials: A Systematic Review.International journal of chronic obstructive pulmonary disease · 2024
    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. Comparative efficacy of combination bronchodilator therapies in COPD: a network meta-analysis.International journal of chronic obstructive pulmonary disease · 2015
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Review
  14. Review
  15. Determinants of medical prescriptions for COPD care: an analysis of the EPOCONSUL clinical audit.International journal of chronic obstructive pulmonary disease · 2018
    Observational
  16. Article
  17. Dual bronchodilation in COPD: lung function and patient-reported outcomes - a review.International journal of chronic obstructive pulmonary disease · 2017
    Review
  18. Determinants for changing the treatment of COPD: a regression analysis from a clinical audit.International journal of chronic obstructive pulmonary disease · 2016
    Article
  19. Review
  20. Review
4 · The record

Corrections and comments

  • Erratum issued
    Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text
5 · Who and what money

Authors and funding

5 authors at 3 institutions in 3 countries.

Ronald DahlDepartment of Dermatology, Allergy Centre, Odense University Hospital, Odense, Denmark.
Dalal Jadayel
Vijay K T Alagappan
Hungta Chen
Donald Banerji
Novartis (United States) · USNovartis (United Kingdom) · GBOdense University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe BEACON study evaluated the efficacy and safety of QVA149, a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237), in development for the treatment of patients with chronic obstructive pulmonary disease (COPD), compared with the free-dose concurrent administration of indacaterol plus glycopyrronium (IND+GLY).

methodsIn this multicenter, double-blind, parallel group study, patients with stage II or stage III COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] 2010) were randomized (1:1) to once-daily QVA149 (110 μg indacaterol/50 μg glycopyrronium) or concurrent administration of indacaterol (150 μg) and glycopyrronium (50 μg) via the Breezhaler® device (Novartis AG, Basel, Switzerland) for 4 weeks. The primary endpoint was to evaluate the noninferiority of QVA149 as compared with concurrent administration of IND+GLY, for trough forced expiratory volume in 1 second (FEV1) after 4 weeks of treatment. The other assessments included FEV1 area under the curve from 0 to 4 hours (AUC0-4 hours) at day 1 and week 4, symptom scores, rescue medication use, safety, and tolerability over the 4-week study period.

resultsOf 193 patients randomized, 187 (96.9%) completed the study.Trough FEV1 at week 4 for QVA149 and IND+GLY was 1.5 L ± 0.02 [DOSAGE ERROR CORRECTED] and 1.46 L ± 0.18, respectively. The FEV1 AUC0-4 hours at day 1 and week 4 were similar between the two treatment groups. Both treatment groups had a similar reduction in symptom scores and rescue medication use for the 4-week treatment period. Overall, 25.6% of patients in QVA149 group and 25.2% in the IND+GLY group experienced an adverse event, with the majority being mild-to-moderate in severity. No deaths were reported during the study or during the 30 days follow-up period.

conclusionThe BEACON study demonstrated that once-daily QVA149 provides an efficacy and safety profile similar to the concurrent administration of its monocomponents indacaterol and glycopyrronium.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleDrug CombinationsDrug Therapy, CombinationFemaleForced Expiratory VolumeGlycopyrrolateHumansIndansLungMaleMiddle AgedAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsGlycopyrrolateindacaterolindacaterol-glycopyrronium combinationIndansMuscarinic AntagonistsQuinolonesCOPDFEV1 AUC0–4 hoursLABALAMArescue medication

Identifiers

PMID24159259
PMCPMC3805248
OpenAlexW2165446260

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.