Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE)

Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) A pragmatic clinical trial with partial registry-based follow-up

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001507-76-SE

Enrollment

1700

Registered

2017-05-08

Start date

2017-09-20

Completion date

Unknown

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary disease

Interventions

Trade Name: Metoprolol Product Name: Metoprolol Pharmaceutical Form: Tablet INN or Proposed INN: Metoprolol CAS Number: 54163-88-1 Other descriptive name: METOPROLOL Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A diagnosis of COPD confirmed by spirometry showing post bronchodilator value of Forced Expiratory Volume in one second (FEV1)//Forced Vital Capacity (FVC) =65 years) yes F.1.3.1 Number of subjects for this age range 1100

Exclusion criteria

Exclusion criteria: - Known hypersensitivity to metoprolol or related derivatives. - AF or other arrhythmias for which beta blockers are indicated according to the investigator discretion. - AV block II or III unless treated with a pacemaker. - Sinus bradycardia (resting heart rate <50/min). - Sick sinus syndrome unless treated with a pacemaker. - Clinical signs of or a previous diagnosis of HF. - Systolic blood pressure <90 mmHg. - Severe bronchial asthma. - Current beta-blocker treatment. - Inability to provide informed consent. - Age below 40 years. - Acute on-going exacerbation of COPD. - Previous randomization in the BRONCHIOLE trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to study the effect of treatment with a cardio-selective beta-blocker (metoprolol) on major adverse cardiac and pulmonary events i.e. death, exacerbations of COPD and cardiovascular events till 1 year, in patients with COPD and no co-existing cardiovascular disease.;Secondary Objective: Our secondary objectives are to study time to all-cause and cause specific death, time to exacerbations of COPD and respectively time to a cardiovascular event within 1 year. Additionally, an extensive health economic analysis will be conducted.;Primary end point(s): A composite of death, exacerbations of COPD, (defined as hospitalization with a primary hospital diagnosis with International Classification of Diseases 10th edition discharge codes for COPD [J44.0 or J44.1] or a COPD exacerbation where a course of per oral steroids was prescribed), and cardiovascular events (AMI, angina pectoris, HF and stroke, TIA or cerebral hemorrhage) requiring hospitalization till 1 year.;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: The primary objective is to study the effect of treatment with a cardio-selective beta-blocker (metoprolol) on major adverse cardiac and pulmonary events i.e. death, exacerbations of COPD and cardiovascular events till 1 year, in patients with COPD and no co-existing cardiovascular disease.;Secondary Objective: Our secondary objectives are to study time to all-cause and cause specific death, time to exacerbations of COPD and respectively time to a cardiovascular event within 1 year. Additionally, an extensive health economic analysis will be conducted.;Primary end point(s): A composite of death, exacerbations of COPD, (defined as hospitalization with a primary hospital diagnosis with International Classification of Diseases 10th edition discharge codes for COPD [J44.0 or J44.1] or a COPD exacerbation where a course of per oral steroids was prescribed), and cardiovascular events (AMI, angina pectoris, HF and stroke, TIA or cerebral hemorrhage) requiring hospitalization till 1 year.;Timepoint(s) of evaluation of this end point: 1 year

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Secondary

Measure	Time frame
Secondary end point(s): - death (all-cause and cause-specific) till 1 year - exacerbation of COPD according to the definition above till 1 year - hospitalization for MI or angina pectoris till 1 year - hospitalization for AF or other forms of arrhythmia - hospitalization for stroke, TIA or cerebral hemorrhage - hospitalization for HF till 1 year - Additionally, an extensive health-economic analysis will be conducted ;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Secondary end point(s): - death (all-cause and cause-specific) till 1 year - exacerbation of COPD according to the definition above till 1 year - hospitalization for MI or angina pectoris till 1 year - hospitalization for AF or other forms of arrhythmia - hospitalization for stroke, TIA or cerebral hemorrhage - hospitalization for HF till 1 year - Additionally, an extensive health-economic analysis will be conducted ;Timepoint(s) of evaluation of this end point: 1 year

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Countries

Sweden

Contacts

Public ContactDepartment of Cardiology

Region Örebro län

josefin.sundh@oru.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026