2025-524501-32-02Not yet recruitingPhase 4
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Mar 2026
Brief summary (registry, in English)
To evaluate the efficacy of Broncho-Vaxom in reducing the rate of moderate (managed at home) and severe (requiring hospitalization) exacerbations in COPD patients during the 6-month treatment period and the subsequent 6-month observation phase.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 1 Feb 2026
- Lead sponsor
- Semmelweis University
- Diseases
- COPD
- EU CT number
- 2025-524501-32-02
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 260
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 80 with confirmed COPD who had repeated flare-ups despite standard treatment. It tests Broncho-Vaxom.
- Age
- 40 to 80 years (the registry header lists a minimum age of 18 years).
- Sex
- Women and men can join.
- Disease stage
- Confirmed COPD with FEV1 above 20% and below 70% of predicted. Lung function must improve by less than 12% after a reversibility test. At least two moderate flare-ups, or one severe flare-up needing hospital care, despite standard treatment.
- Earlier treatment
- Must be taking standard COPD treatment as in the GOLD guidelines. Must not have taken immunosuppressants or oral steroids in the last month, antibiotics in the last 4 weeks, or bacterial lysate in the last 12 months (at least 4 weeks before entering).
Main reasons for not taking part
- Not following standard COPD treatment properly
- Cannot walk far enough to come to the visits
- Allergy or hypersensitivity to Broncho-Vaxom
- Recent use of immunosuppressants, oral steroids, antibiotics or bacterial lysate
- Any other condition or situation the investigator thinks could confuse the results or make taking part not in the person's interest
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with inadequate compliance with standard therapies for COPD.
- Patients who take immunosuppressants or oral corticosteroids within 1 month before entering the study.
- Patients who take antibiotics within 4 weeks before entering the study.
- Patients who take bacterial lysate in the previous 12 months at least 4 weeks before entering the study.
Other illness
- Has a hypersensitivity to Broncho-Vaxom.
Lab values
- Has a history or current evidence of any condition, therapy or laboratory abnormality or other circumstances that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, such that is not in the best interest of the participant to participate, in the opinion of the investigator.
Other
- Patients who are unable to walk enough distance to come to the visit.
Who the study is looking for
- Has confirmed diagnosis of COPD.
- The participant provides documented informed consent/assent for the study.
- At least two moderate or one severe exacerbations requiring hospitalization (for 3 days steroid therapy or antibiotic therapy due to exacerbation), despite adherence to standard treatment as outlined in the GOLD guidelines
- FEV1>20%pred and FEV1<70%pred
- BMI: 18 kg/m2 – 40 kg/m2
- Female and male patients between 40 years and 80 years.
- Heavy smoking anamnesis: >20 years smoking history
- Not reversible <12%pred FEV1 with reversibility test
- Male participants agree to use contraception method through the study conduct
- Contraceptive use by women and men should be consistent with local regulation regarding the methods of contraception for those participating in studies.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Semmelweis University | Budapest VIII | Hungary | Not yet recruiting |
| University of Pecs | Pécs | Hungary | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.