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

慢性阻塞性肺疾病 (细支气管) 患者的 β 受体阻滞剂-随机对照试验的研究方案

  • 影响因子:2.12
  • DOI:10.1186/s13063-019-3907-1
  • 作者列表:"Josefin Sundh","Anders Magnuson","Scott Montgomery","Pontus Andell","Gustaf Rindler","Ole Fröbert","the BRONCHIOLE investigators
  • 发表时间:2020-02-02
Abstract

Abstract 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. Trial registration ClinicalTrials.gov, ID: NCT03566667. Registered on 25 June 2018.

摘要

摘要背景观察性研究表明,即使没有明显的心血管疾病,β 受体阻滞剂也能降低慢性阻塞性肺疾病 (COPD) 患者的恶化风险和死亡率。但是缺乏随机对照试验 (RCT) 的数据。本 RCT 的目的是研究 β 受体阻滞剂治疗无确诊心血管疾病的 COPD 患者是否与死亡、急性加重、或心血管事件。方法 β 受体阻滞剂对慢性阻塞性肺病 (细支气管) 患者的研究是一项开放标签、多中心、前瞻性 RCT。共有 1700 例 COPD 患者将被随机分配到标准 COPD 治疗和美托洛尔,目标剂量为 100 mg/天,或仅到标准 COPD 治疗。主要终点是死亡、 COPD 加重和心血管事件的复合终点。主要排除标准为缺血性心脏病、左侧心力衰竭、脑血管疾病、严重肢体缺血和房颤/房扑。研究访视为纳入访视、 1 个月美托洛尔滴定访视、 6 个月电话随访、 1 年后最终研究访视。结果数据来自研究访视期间的病史和记录审查,以及国家登记处。讨论细支气管是一项实用的随机试验,旨在探讨 β 受体阻滞剂在 COPD 患者中的应用潜力。该试验有望提供该治疗对 COPD 患者患者相关结局疗效的相关临床数据。试用注册 ClinicalTrials.gov,ID: nct03566667。2018年6月25日注册。

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