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Study of the effect of lyophilized bacterial lysates on reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the effect of Broncho-Vaxom on Chronic Obstructive Pulmonary Disease (COPD) exacerbations. An exacerbation is a sudden worsening of symptoms, such as increased shortness of breath or coughing, that requires extra medical attention. The medication used, Broncho-Vaxom, consists of lyophilized bacterial lysates, which are substances made from inactivated parts of bacteria used to help the body's immune system. Some participants will receive the active medication, while others will receive a placebo.

During the study, participants will be monitored for changes in their breathing and general health. The process includes a six-month period where the medication is taken, followed by a six-month observation period to see how the body responds after the treatment ends. The study also looks at respiratory tract infections, which are illnesses affecting the nose, throat, or lungs, and how they relate to the worsening of COPD. Additionally, aspects such as physical activity, body composition, and overall quality of life will be observed throughout the duration of the study.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>treatment phase</b>
For a period of 6 months, a daily dose of 40 mg of broncho-vaxom (a capsule containing inactivated bacteria to help the immune system) is taken by mouth.
Alternatively, a placebo (a powder without an active ingredient) is taken by mouth for the same 6-month duration.
Step 2
<b>observation phase</b>
Following the treatment period, an observation phase lasts for another 6 months.
During this time, the frequency of copd exacerbations (sudden worsening of chronic obstructive pulmonary disease symptoms, which may be managed at home or require hospital care) is monitored.

Who can join the trial?

11 criteria

You must have a confirmed diagnosis of COPD, which is a chronic lung disease that makes it difficult to breathe.
You must provide informed consent, which means you have read about the study and formally agreed to participate.
You must have had at least two moderate exacerbations (sudden worsening of symptoms that can be managed at home) or at least one severe exacerbation (a sudden worsening of symptoms that requires staying in the hospital).
The worsening of your condition must have required steroid therapy (medicine used to reduce swelling) or antibiotic therapy (medicine used to fight infections) for at least 3 days.
Your FEV1, which is a measurement of how much air you can forcefully breathe out in one second, must be between 20% and 70% of the amount expected for a healthy person of your age and size.
Your BMI, or Body Mass Index (a measure of your body weight relative to your height), must be between 18 and 40.
You must be a man or a woman between the ages of 40 and 80 years old.
You must have a history of heavy smoking, defined as having smoked for more than 20 years.
Your lung function must be not reversible, meaning that after using a breathing treatment, your FEV1 does not improve by more than 12% of the predicted value.
Men participating in the study must agree to use contraception (methods to prevent pregnancy) during the study period.
Both men and women must use contraception in a way that follows local rules for people participating in clinical research.

Who cannot join the trial?

7 criteria

Patients who do not follow their regular medical treatments for COPD (a chronic lung disease that makes it hard to breathe) correctly.
Patients who are unable to walk a sufficient distance to attend study appointments.
Patients who have used immunosuppressants (medicines that lower the body's ability to fight infection) or oral corticosteroids (steroid medicines taken by mouth) within one month before the study begins.
Patients who have taken antibiotics (medicines used to kill bacteria) within the four weeks before the study starts.
Patients who have used bacterial lysate (a type of medicine made from pieces of bacteria used to help the immune system) at any time in the last 12 months, provided it was at least four weeks before the study begins.
Patients who have an allergy or extreme sensitivity to the study medicine, Broncho-Vaxom.
Patients with any other medical issues, treatments, or unusual laboratory results (test results from blood or other fluids) that could make the study results difficult to interpret or could make participating in the study unsafe or not in the patient's best interest.

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University Of Pecs
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Pecs, Hungary

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Investigated drugs

Broncho-Vaxom is an oral capsule containing inactivated parts of several common bacteria that can cause respiratory infections. It is used to help stimulate the body's immune system to better defend against these germs, with the goal of reducing the frequency of lung flare-ups in people with chronic obstructive pulmonary disease.

What is already known about the treatment

Broncho-Vaxom - This medication is taken orally in the form of a hard capsule. It is a well-established product used to help prevent respiratory infections by containing inactivated pieces of several common bacteria. It works by training the body's immune system to recognize and fight these specific bacteria more effectively, acting as a way to boost natural defenses. This substance is classified as an immunomodulator used to reduce the frequency of lung-related flare-ups in patients with chronic respiratory conditions.

Investigated diseases

COPD exacerbation - This condition involves a sudden worsening of symptoms in people living with chronic obstructive pulmonary disease. During an exacerbation, the airflow in the lungs becomes more restricted than usual. Common signs include increased shortness of breath, a change in the color or amount of mucus produced, and a persistent cough. These episodes can occur frequently and may vary in intensity. Some episodes can be managed at home, while more intense ones may require medical care in a hospital.