Ongoing, recruitingTherapeutic use (Phase IV)Interventional

COPD - Eosinophil-guided Reduction of Inhaled Corticosteroids (COPERNICOS)

This study, called COPERNICOS, focuses on people living with Chronic Obstructive Pulmonary Disease (COPD). We're investigating different versions of a medicine called azithromycin and comparing them to a dummy pill (placebo). The main goal is to see if these treatments can lower the number of times people with COPD need to be hospitalised or unfortunately pass away over a 365-day period. We're also looking at other important things like how often people have flare-ups, their lung function, and their general quality of life. This research aims to find better ways to manage COPD and improve patients' health.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Gentofte Hospital, Frederiksberg Hospital

Enrolment target

444

Start

23 Aug 2022

Chronic obstructive pulmonary disease (COPD)

What is this study about?

If you have a long-term lung condition called COPD, you might be interested in a study called COPERNICOS. This study is designed to help us understand more about how certain medicines can affect people with COPD. Specifically, it's looking at a type of antibiotic called azithromycin. We want to see how different forms of this medicine, compared to a dummy pill (placebo), might help reduce serious problems often faced by people with COPD.

The main thing we're trying to find out is whether taking these medicines can lower the number of times someone with COPD needs to go to the hospital because of their condition, or unfortunately, passes away within a year. But we're also checking many other important things. For example, we'll be looking at how often people have sudden worsening of their symptoms, known as flare-ups, and how their breathing changes over time.

We'll also keep an eye on how much steroid medicine people need to take, both inhaled and tablets, and how their quality of life changes. Doctors will also be looking at other health markers like blood sugar levels, and even how the germs in their airways might change. All of this information will help doctors understand the best ways to manage COPD and help people live better with the condition.

Key takeaways

This study investigates different forms of an antibiotic called azithromycin for COPD.
The main goal is to see if it reduces hospital stays and deaths over a year.
Participants will receive either the study medicine or a dummy pill.
The study also tracks flare-ups, lung function, and quality of life.
It's open to adults aged 18 and over with a COPD diagnosis.

Who may be eligible?

This study is open to adults aged 18 and over, regardless of whether you are male or female. You would need to have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

There might be some specific health details or other medications you're taking that could mean this study isn't suitable for you. This is common with all research studies, as it helps make sure the results are clear and that you are safe.

The study team will carefully check all your medical information during a screening visit to decide if taking part is a good option for you.

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 COPD?
Are you willing to attend regular clinic visits for one year?
Are you happy to potentially receive a dummy pill (placebo)?
Are you comfortable with blood tests and lung function checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be given either one of the azithromycin medicines or a dummy pill (placebo) to take. You wouldn't know which one you are receiving. The study will last for a total of 365 days after you start.

Throughout the year, you'll have regular visits to the clinic where the study team will monitor your health. They will perform tests like checking your breathing (lung function), taking blood samples, and asking questions about your symptoms and how you are feeling. They will also keep track of any hospital stays or changes in your usual medications. It's important to attend all scheduled visits and report any changes in your health to the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving regular health checks and close monitoring of your COPD by medical professionals. The study medicine might also help manage your condition, though this isn't guaranteed as some participants will receive a dummy pill. Potential risks might include side effects from the study medicine, even if it's the dummy pill. Like all medicines, azithromycin can have side effects. You will be fully informed of all known risks and have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a common long-term lung condition that causes breathing difficulties.

What is azithromycin?

Azithromycin is a type of antibiotic medication often used to treat various bacterial infections.

What does 'placebo' mean?

A placebo is a dummy pill or treatment that looks the same as the active medicine but doesn't contain any active ingredients. It helps us see if the real medicine is truly working.

Will I know if I'm getting the real medicine or the placebo?

No, in this type of study, neither you nor the study doctors will know whether you are receiving the active medicine or the placebo. This helps ensure unbiased results.

How long will I be in the study?

If you join, your participation in the study will last for one year (365 days).

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.