AuthorisedTherapeutic use (Phase IV)Interventional

The effect of Broncho-Vaxom on the COPD exacerbations in terms of lung function, lung mechanics, immune state, body composition, quality of life and physical activity.

This research is investigating a medication called Broncho-Vaxom. The main goal is to find out if it can reduce the number of moderate or severe flare-ups (exacerbations) of Chronic Obstructive Pulmonary Disease (COPD) over a year. Researchers will also be looking at several other things. These include whether it improves lung function, how it affects the body's defence system, and if it helps people feel better and be more active in their daily lives. They will compare the effects of Broncho-Vaxom with a dummy pill (placebo) to see if it truly makes a difference for adults living with COPD.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Semmelweis University, University Of Pecs

Enrolment target

260

Start

13 Mar 2026

COPD exacerbation

What is this study about?

This study is all about helping people with a lung condition called Chronic Obstructive Pulmonary Disease, or COPD. If you have COPD, you might experience "exacerbations." These are times when your breathing suddenly gets much worse, and you might need extra treatment at home or even a hospital stay. The researchers in this study want to see if a medicine called Broncho-Vaxom can help reduce how often these flare-ups happen over a year.

The study isn't just looking at the number of flare-ups, though. They are also very interested in how Broncho-Vaxom might affect other important aspects of living with COPD. For example, they'll be checking if it helps your lungs work better, if it boosts your body's immune system to fight off infections, and if it improves how you feel day-to-day. They'll also look at things like your ability to do physical activities and your overall quality of life.

This kind of study is really important because it helps doctors understand which treatments work best for people with COPD. By carefully comparing Broncho-Vaxom to a dummy pill, they can figure out if this medication truly offers benefits and helps people with COPD lead healthier, more active lives.

Key takeaways

Tests Broncho-Vaxom for reducing COPD flare-ups.
Looks at lung health, immunity, and quality of life.
Compares active medicine to a dummy pill.
Participants must have COPD and be over 18.
Lasts for 12 months with regular health checks.

Who may be eligible?

This study is looking for adult volunteers. You must be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to participate.

The main requirement is that you have COPD and experience flare-ups, as the study is focused on reducing these sudden worsenings of your 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 Chronic Obstructive Pulmonary Disease (COPD)?
Do you experience flare-ups (exacerbations) of your COPD?
Are you able to attend regular appointments for one year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking either the Broncho-Vaxom medicine or a dummy pill (which contains no active ingredient) in capsule form. The study will last for 12 months. Throughout this year, you would have several visits to the clinic for assessments. These assessments will help the researchers understand how the treatment is affecting you. They will involve checking your lung function, which might include breathing tests where you blow into a machine. They will also ask you questions about your symptoms, your general health, and how well you can do daily physical activities. You would also report any illnesses or side effects you experience. All these measurements will be compared from the beginning to the end of the study.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit if Broncho-Vaxom helps reduce your COPD flare-ups, improves your breathing, or boosts your overall health, but there's no guarantee the treatment will work for you. There's also a chance you could experience side effects from the medication, which the study team will monitor closely. You always have the right to leave 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
Hungary

Common questions

What are COPD exacerbations?

These are sudden worsening of your COPD symptoms, like breathlessness or coughing, that often need extra treatment or a hospital visit.

What is Broncho-Vaxom?

It's a medicine being tested to see if it can help reduce the frequency of COPD flare-ups.

Will I definitely get the active medicine?

No, this study compares Broncho-Vaxom to a "dummy pill" (placebo), so you might receive either.

How long will the study last?

The study will last for 12 months, with regular check-ups during that time.

What if I feel unwell during the study?

The study team will monitor your health closely, and you can report any concerns or side effects immediately.