NCT03566667CompletedPhase 4
Beta-blockers to Patients With Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1713 (actual)
- First submitted
- 12 Jun 2018
- Start date
- 12 Jun 2018
- Primary completion date
- 29 Dec 2025
- Lead sponsor
- Ole Frobert, MD, PhD
- Diseases
- COPD
- NCT number
- NCT03566667
- EU CT number
- 2024-512407-39-00
- EudraCT number
- 2017-001507-76
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1713
- From 12 Jun 2018 to the primary completion date, 29 Dec 2025
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- AV block II or III unless treated with a pacemaker
- Sick sinus syndrome unless treated with a pacemaker
- Clinical signs of or a previous diagnosis of heart failure, angina pectoris, myocardial infarction, cerebrovascular disease or critical peripheral ischemia
- Previous randomization in the BRONCHIOLE trial
Other illness
- Known hypersensitivity to metoprolol or related derivatives
- Sinus bradycardia (resting heart rate \<50/min)
Age
- Age below 40 years
Other
- Atrial fibrillation/flutter
- 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
- Acute on-going exacerbation of COPD
- Ongoing pregnancy (excluded by pregnancy test in fertile women)
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Dalarna Coordinator of this site? Confirm its status | Falun | Sweden | Completed |
| Region Gaevleborg Coordinator of this site? Confirm its status | Gavle | Sweden | Completed |
| Region Skane Kristianstad Central Hospital Coordinator of this site? Confirm its status | Kristianstad | Sweden | Completed |
| Region Oestergoetland Coordinator of this site? Confirm its status | Linkoping | Sweden | Completed |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Completed |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Completed |
| Region Uppsala Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
| Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Vänersborg | Sweden | Completed |
Related publications
- Metoprolol in Chronic Obstructive Pulmonary Disease without Cardiovascular Disease.NEJM Evid · 2026 · PMID 42701865
This page is information, not medical advice. Discuss any trial with your doctor.