CompletedPhase 4

Beta-blockers to Patients With Chronic Obstructive Pulmonary Disease

Sweden1,713 participantsStarted 2018-06-12

Plain-language summary

Background: In patients with chronic obstructive pulmonary disease (COPD) and concomitant cardiovascular conditions cardio-selective beta-blockers reduce mortality and can be used without significant negative effects on lung function or respiratory symptoms. Observational studies indicate that beta-blocker therapy in COPD even without overt cardiovascular disease, is associated with reduced risk for mortality and COPD exacerbations. Aim: The overall purpose of our study is to examine the benefit of general beta-blocker therapy on important patient-oriented measures in chronic obstructive pulmonary disease (COPD). Our primary hypothesis that treatment with beta-blockers in patients with COPD and no comorbid heart disease at baseline can prevent a Composite measure of hospitalizations due to cardiovascular diseases, COPD exacerbations and death. Population: 1700 patients with C OPD. Inclusion criteria are FEV1/FVC \< 70, age \>40 years and sinus rhythm 50-120/min. Exclusion criteria include hypersensitivity against metoprolol, atrioventricular (AV) block II or II or sick sinus syndrome without pacemaker, atrial fibrillation or flutter, clinical signs of or previously known cardiovascular disease, systolic blood pressure \< 90, severe asthma, present beta-blocker therapy or ongoing COPD exacerbation. Intervention: Metoprolol at a target dose of 100 mg in addition to standard COPD care. Control: No placebo control. Randomized, pragmatic un-blinded controlled study where the control Group receives standard COPD care. Outcome: The primary outcome is a composite measure of all-cause mortality, C OPD exacerbations, and cardiovascular events after one year. Endpoint data from Swedish national registries and clinical follow-up. Importance: Beta-blocker treatment to attenuate morbidity in patients with COPD could have great clinical and social importance at a low cost.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) \< 70 according to the Global Initiative on Obstructive Pulmonary Disease (GOLD) * ≥40 years of age * Sinus rhythm ≥50/min and \<120 at inclusion Exclusion Criteria: * Known hypersensitivity to metoprolol or related derivatives * 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 * Atrial fibrillation/flutter * Clinical signs of or a previous diagnosis of heart failure, angina pectoris, myocardial infarction, cerebrovascular disease or critical peripheral ischemia * Systolic blood pressure \<90 mmHg * Any tachy-arrythmias other than sinus rhythm * Sinus tachycardia \>120 / min * 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 * Ongoing pregnancy (excluded by pregnancy test in fertile women)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mortality, exacerbations and cardiovascular events

Timeframe: One year

Trial details

NCT IDNCT03566667

SponsorOle Frobert, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-29

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials