Ongoing, recruitingTherapeutic use (Phase IV)Interventional

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

The BRONCHIOLE study is investigating how a common heart medicine, called a beta-blocker (Seloken), affects people who also have a long-term lung condition called chronic obstructive pulmonary disease (COPD). Researchers want to understand if taking this medicine can help improve overall health, reduce the number of times someone experiences a serious flare-up of their COPD symptoms, and lower the risk of heart-related events like heart attacks, heart failure, or strokes. Instead of new tests, this study uses existing health information from medical records in Sweden. It looks at a combination of important health outcomes, including whether participants live longer, how often their COPD gets worse, and if they experience serious heart or circulation issues. This type of study helps us learn more about how medicines work in real-world situations for people with complex health needs.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Region Oerebro Laen

Enrolment target

1,700

Start

09 Jul 2024

Chronic obstructive pulmonary disease

What is this study about?

The BRONCHIOLE study is looking into a specific type of medicine called a beta-blocker, known as Seloken (which comes in 50mg and 100mg tablets). Beta-blockers are commonly used to treat heart conditions like high blood pressure or angina. However, this study is focusing on how Seloken affects people who also have a long-term lung condition called chronic obstructive pulmonary disease, or COPD.

The main goal of the study is to see if taking Seloken can make a real difference in the health of people with COPD. Specifically, it's looking at a combination of important health events: how long people live, how often they experience a serious worsening of their COPD (called an exacerbation), and whether they have serious heart or circulation problems like a heart attack, heart failure, or a stroke. To do this, researchers aren't asking people to take new tests or visit clinics; instead, they are using existing medical records from Sweden to gather this information.

This type of study is called a 'Phase IV' study. This means the medicine (Seloken) is already approved and used by doctors, but researchers want to learn more about its effects when used in a wider group of people, especially those with other health conditions like COPD. By studying existing records, they can understand how the medicine works in everyday life and gather important information that might help doctors make better decisions about treating people with both heart conditions and COPD in the future.

Key takeaways

Known drug (Seloken) being studied for its effects in people with existing COPD.
Data collected from existing medical records, not new patient involvement.
Aims to understand combined effect on death, COPD flare-ups, and heart events.
Study contributes to understanding how a common heart medicine affects those with lung disease.
No direct participation, new medicines, or appointments for individuals involved.

Who may be eligible?

To be included in this study, participants needed to be adults, aged 18 years or older. There is no upper age limit, meaning people of all adult ages could be considered.

Both men and women were eligible to take part in this research.

Because this study uses existing health records rather than recruiting new patients for treatment, specific individual checks are not needed in the same way a new drug trial would require. However, the study specifically focuses on individuals who have been diagnosed with chronic obstructive pulmonary disease (COPD) and would have been prescribed Seloken for a separate health condition.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of chronic obstructive pulmonary disease (COPD)?
Have you been prescribed Seloken (a type of beta-blocker) by your doctor?
Were your medical records kept in Sweden at the time?

Answer every question to see your result.

What does participation involve?

As this study uses existing medical records from the Swedish National Patient Register and primary care records, you wouldn't directly 'participate' in the way you might in a traditional clinical trial. There are no clinic visits, no new medications to take, and no extra tests. Your personal health information, already recorded by your doctors, is being used anonymously to understand health patterns. This means there's no direct involvement for individuals, no follow-up appointments, and no specific duration for anyone taking part.

Potential risks and benefits

Since this study uses existing medical records and doesn't involve any new treatments or procedures, there are no direct physical risks to individuals. Your personal identifiable information would be kept private and handled carefully. The potential benefit is that the findings from this study could help doctors better understand how beta-blockers affect people with COPD, potentially leading to improved care and treatment decisions in the future. As you are not actively taking part, there is no personal right to withdraw in the traditional sense, but strict rules are followed to protect your data.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe, often caused by smoking.

What is Seloken?

Seloken is a medicine known as a beta-blocker, usually prescribed for conditions like high blood pressure or heart problems.

Am I being given new medicine in this study?

No, this study is reviewing information from people who have already been taking Seloken as prescribed by their doctor as part of their usual care. You wouldn't be given any new medicine.

Will this study affect my own medical care?

No, this study uses existing records and does not directly change your medical care. The results may help inform future treatments generally, but not your individual treatment.

What does a 'Phase IV' study mean?

It means the medicine is already approved and in use. This study is collecting more information about its effects over a longer time and in different groups of people.