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Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) - Study protocol from a randomized controlled trial
Örebro University, School of Medical Sciences. Department of Respiratory Medicine.ORCID iD: 0000-0003-1926-8464
Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden.
Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden; Clinical Epidemiology Division, Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden; Department of Epidemiology and Public Health, University College London, London, United Kingdom.ORCID iD: 0000-0001-6328-5494
Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Heart and Vascular Division, Karolinska University Hospital, Stockholm, Sweden.
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2020 (English)In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 123Article in journal (Refereed) Published
Abstract [en]

Background: Observational 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.

Methods: The 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.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2020. Vol. 21, no 1, article id 123
Keywords [en]
Beta-blocker, Cardiovascular event, COPD, Exacerbation, Mortality, Pragmatic randomized trial, Real-world evidence
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:oru:diva-80376DOI: 10.1186/s13063-019-3907-1ISI: 000513538600001PubMedID: 32000825Scopus ID: 2-s2.0-85078711805OAI: oai:DiVA.org:oru-80376DiVA, id: diva2:1411627
Funder
Swedish Research Council, 2018-00511
Note

Funding Agencies:

Swedish Respiratory Society  

Uppsala-Örebro Regional Research Council  RFR-851601

Örebro University  ORU 2018/01219

Region Örebro County through ALF research funding  OLL-843061

Available from: 2020-03-04 Created: 2020-03-04 Last updated: 2024-01-17Bibliographically approved

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Sundh, JosefinMontgomery, ScottFröbert, Ole

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