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ArticleTrials2020

Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) - Study protocol from a randomized controlled trial.

Josefin Sundh, Anders Magnuson, Scott Montgomery, Pontus Andell, Gustaf Rindler, Ole Fröbert, BRONCHIOLE investigators

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03566667 (Beta-blockeRs tO patieNts With CHronIc Obstructive puLmonary diseasE), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 19% 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.

NCT03566667 phase4completednot on this map

Beta-blockeRs tO patieNts With CHronIc Obstructive puLmonary diseasE

TypeinterventionalSponsorOle Frobert, MD, PhDRan2018 to 2026Enrolled1,713ConditionsChronic Obstructive Pulmonary DiseaseArmsMetoprolol, Standard care
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
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  4. Review
  5. Review
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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 2 institutions in 2 countries.

Josefin SundhDepartment of Respiratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. josefin.sundh@regionorebrolan.se.ORCID http://orcid.org/0000-0003-1926-8464
Anders MagnusonClinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden.
Scott MontgomeryClinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden.
Pontus AndellUnit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Gustaf RindlerLekeberg Primary Health Care Centre, Örebro, Sweden.
Ole FröbertDepartment of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
BRONCHIOLE investigators
Örebro University · SEKarolinska University Hospital · SE

Funding

Örebro Universitet ORU 2018/01219Regionala forskningsrådet Uppsala Örebro RFR-851601Region Örebro län OLL-843061Svensk Lungmedicinsk Förening 2018Vetenskapsrådet 2018-00511
6 · The paper itself

Abstract

backgroundObservational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascular disease, but data from randomized controlled trials (RCT) are lacking. The aim of this RCT is to investigate whether beta-blocker therapy in patients with COPD without diagnosed cardiovascular disease is associated with a decreased 1-year risk of the composite endpoint of death, exacerbations, or cardiovascular events.

methodsThe Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) study is an open-label, multicentre, prospective RCT. A total of 1700 patients with COPD will be randomly assigned to either standard COPD care and metoprolol at a target dose of 100 mg per day or to standard COPD care only. The primary endpoint is a composite of death, COPD exacerbations, and cardiovascular events. Major exclusion criteria are ischemic heart disease, left-sided heart failure, cerebrovascular disease, critical limb ischemia, and atrial fibrillation/flutter. Study visits are an inclusion visit, a metoprolol titration visit at 1 month, follow-up by telephone at 6 months, and a final study visit after 1 year. Outcome data are obtained from medical history and record review during study visits, as well as from national registries. DISCUSSION: BRONCHIOLE is a pragmatic randomized trial addressing the potential of beta-blockers in patients with COPD. The trial is expected to provide relevant clinical data on the efficacy of this treatment on patient-related outcomes in patients with COPD.

trial registrationClinicalTrials.gov, ID: NCT03566667. Registered on 25 June 2018.

Indexed as

Pulmonary Disease, Chronic ObstructiveAdrenergic beta-AntagonistsCardiovascular DiseasesEndpoint DeterminationFemaleHumansMaleMetoprololMiddle AgedMortalityPragmatic Clinical Trials as TopicPrognosisRandomized Controlled Trials as TopicSymptom Flare UpAdrenergic beta-AntagonistsMetoprololBeta-blockerCardiovascular eventCOPDExacerbationMortalityPragmatic randomized trialReal-world evidence

Identifiers

PMID32000825
PMCPMC6993405
OpenAlexW3003210602

What OpenQuestion holds

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LicenceCC BY
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.