Study on the Effects of Metoprolol Tartrate for Patients with Chronic Obstructive Pulmonary Disease (COPD) Without Cardiovascular Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Seloken, which contains the active ingredient metoprolol tartrate. The study is specifically looking at patients with Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes it hard to breathe. The purpose of the study is to see if using this medication can help protect against worsening of COPD, heart-related events, and death in patients who have COPD but no other heart diseases.

Participants in the study will be given either Seloken or a placebo. The medication is taken orally in the form of a tablet. The study will last for up to 12 months, during which time the health of the participants will be monitored to see if there are any changes in their condition. The researchers will be looking at how long it takes for any serious health events to occur, such as worsening of COPD symptoms, heart attacks, or strokes.

The study aims to gather information on whether Seloken can be beneficial for people with COPD in terms of reducing the risk of serious health issues. This information could help in understanding the potential benefits of using beta-blockers, like metoprolol tartrate, in managing COPD. The results will also include an analysis of the economic impact of using this treatment.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) through a breathing test called spirometry. This test measures the amount of air the patient can exhale in one second and compares it to the total amount of air exhaled.

The patient must be at least 40 years old and have a history of smoking or exposure to smoke, gas, or dust. The heart rate should be between 50 and 120 beats per minute at the time of joining.

Written informed consent is required to participate in the study.

2 medication administration

The patient will receive a medication called Seloken, which contains the active ingredient metoprolol tartrate. This medication is a type of beta-blocker.

Seloken is available in two dosages: 50 mg and 100 mg tablets. The medication is taken orally.

The specific dosage and frequency of administration will be determined by the study protocol and the patient’s individual needs.

3 monitoring and follow-up

Throughout the study, the patient will be monitored for any changes in their health, particularly focusing on the occurrence of COPD exacerbations, cardiovascular events, and overall survival.

The study aims to determine if beta-blocker treatment can protect against these health issues in patients with COPD who do not have existing heart disease.

4 study duration

The study is expected to continue until December 31, 2025.

During this time, data will be collected and analyzed to assess the effectiveness and safety of the treatment.

Who Can Join the Study?

Have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD). This is a lung condition that makes it hard to breathe. The diagnosis should be confirmed by a test called spirometry, which measures how well your lungs work. The test should show a specific result called FEV1/FVC less than 70, according to guidelines.
Have a history of smoking or exposure to smoke, gas, or dust at work or in the environment.
Be 40 years of age or older.
Have a heart rhythm called sinus rhythm with a heart rate of 50 to less than 120 beats per minute at the time of joining the study.
Be able to provide written informed consent, which means you understand the study and agree to participate.

Who Cannot Join the Study?

Patients with Chronic Obstructive Pulmonary Disease (COPD) who also have other heart-related diseases cannot participate. COPD is a lung condition that makes it hard to breathe.
Patients who are not within the specified age range for the study cannot participate. The study is looking for people in certain age groups.
Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible for this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Vaestra Goetalandsregionen	Vänersborg	Sweden
Region Dalarna	Falun	Sweden
Region Uppsala	Uppsala	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden
Region Halland	Varberg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	18.05.2018

Trial locations

Investigated drugs:

Metoprolol Tartrate

Beta-blockers are medications commonly used to manage heart conditions by slowing down the heart rate and reducing blood pressure. In this trial, they are being studied to see if they can help patients with Chronic Obstructive Pulmonary Disease (COPD) who do not have any existing heart disease. The goal is to find out if beta-blockers can reduce the number of COPD flare-ups, prevent heart-related problems, and lower the risk of death in these patients.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic Obstructive Pulmonary Disease – This is a long-term lung condition that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, leading to breathing difficulties. The disease progresses slowly and is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. Over time, symptoms such as chronic cough, mucus production, and shortness of breath become more severe. As the disease advances, it can lead to frequent respiratory infections and increased difficulty in performing daily activities. The condition is not reversible, but its progression can be managed with lifestyle changes and medical interventions.

Trial ID:

2024-512407-39-00

Protocol code:

BRONCHIOLE-2017

NCT ID:

NCT03566667

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Metoprolol Tartrate for Patients with Chronic Obstructive Pulmonary Disease (COPD) Without Cardiovascular Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?