Evidence map›Paper›PMID 33149571›Full record

ArticleInternational journal of chronic obstructive pulmonary disease2020

Extrafine Beclometasone Dipropionate/Formoterol Fumarate vs Double Bronchodilation Therapy in Patients with COPD: A Historical Real-World Non-Inferiority Study.

Jaco Voorham, Simonetta Baldi, Luigi Santoro, Marjan Kerkhof, Marco Contoli, Leonardo M Fabbri, Huib A M Kerstjens, Jose Luis López-Campos, Nicolas Roche, Dave Singh and 2 more

Open access · goldAbstract read
In one paragraph

Article in International journal of chronic obstructive pulmonary disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 80% 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

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Article
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

12 authors at 9 institutions in 6 countries.

Jaco VoorhamObservational & Pragmatic Research Institute Pte Ltd, Singapore, Singapore.ORCID 0000-0001-9002-1865
Simonetta BaldiDepartment of Global Clinical Development, Chiesi SAS, Bois Colombes Cedex, France.ORCID 0000-0002-1984-6730
Luigi SantoroDepartment of Global Clinical Development, Chiesi Farmaceutici S.p.A, Parma, Italy.
Marjan KerkhofObservational & Pragmatic Research Institute Pte Ltd, Singapore, Singapore.ORCID 0000-0002-3823-1061
Marco ContoliSection of Respiratory Medicine, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy.ORCID 0000-0002-2731-5809
Leonardo M FabbriSection of Respiratory Medicine, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy.ORCID 0000-0001-8894-1689
Huib A M KerstjensDepartment of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0001-7705-7927
Jose Luis López-CamposRespiratory Diseases Unit, University Hospital Virgen Del Rocío, Seville, Spain.ORCID 0000-0003-1703-1367
Nicolas RocheService de Pneumologie, Hôpital Cochin, APHP, Centre-Université de Paris, Paris, France.ORCID 0000-0002-3162-5033
Dave SinghUniversity of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.
Claus F VogelmeierDepartment of Internal Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany.
David B PriceObservational & Pragmatic Research Institute Pte Ltd, Singapore, Singapore.ORCID 0000-0002-9728-9992
Observational & Pragmatic Research Institute · SGUniversity of Ferrara · ITChiesi (France) · FRChiesi (Italy) · ITHospital Universitario Virgen del Rocío · ESManchester University NHS Foundation Trust · GBUniversité Paris Cité · FRUniversity Medical Center Groningen · NLUniversity of Aberdeen · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This study aimed to evaluate the non-inferiority of initiating extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) versus double bronchodilation (long-acting beta-agonists [LABA]/long-acting muscarinic antagonists [LAMA]) among patients with a history of chronic obstructive pulmonary disease (COPD) exacerbations. Patients and Methods: A historical cohort study was conducted using data from the UK's Optimum Patient Care Research Database. Patients with COPD ≥40 years at diagnosis were included if they initiated extrafine BDP/FF or any LABA/LAMA double therapy as a step-up from no maintenance therapy or monotherapy with inhaled corticosteroids (ICS), LAMA, or LABA and a history of ≥2 moderate/severe exacerbations in the previous two years. The primary outcome was exacerbation rate from therapy initiation until a relevant therapy change or end of follow-up. Secondary outcomes included rate of acute respiratory events, acute oral corticosteroids (OCS) courses, and antibiotic prescriptions with lower respiratory indication, modified Medical Research Council score (mMRC) ≥2, and time to first pneumonia diagnosis. The non-inferiority boundary was set at a relative difference of 15% on the ratio scale. Five potential treatment effect modifiers were investigated. Results: A total of 1735 patients initiated extrafine BDP/FF and 2450 patients initiated LABA/LAMA. The mean age was 70 years, 51% were male, 41% current smokers, and 85% had FEV Conclusion: This study found that stepping up to extrafine BDP/FF from no maintenance or monotherapy was not inferior to stepping up to double bronchodilation therapy in patients with a history of exacerbations.

Indexed as

BeclomethasonePulmonary Disease, Chronic ObstructiveAdministration, InhalationAdrenergic beta-2 Receptor AgonistsAgedBronchodilator AgentsCohort StudiesFormoterol FumarateHumansMaleMuscarinic AntagonistsAdrenergic beta-2 Receptor AgonistsBeclomethasoneBronchodilator AgentsFormoterol FumarateMuscarinic Antagonistschronic obstructive pulmonary diseasecomparative effectivenesselectronic health recordsheterogeneityobservationalreal-world

Identifiers

PMID33149571
PMCPMC7605609
OpenAlexW3092299836

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.