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Beta-blockers to Patients With Chronic Obstructive Pulmonary Disease

NCT03566667 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1713

Last updated 2025-04-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metoprolol

Betablocker

DRUG

Standard care

Standard care

Sponsors & Collaborators

  • Ole Frobert, MD, PhD

    lead OTHER

Principal Investigators

  • Ole Fröbert, MD, PhD · Region Örebro County

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2025-12-01
Completion
2026-04-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03566667 on ClinicalTrials.gov