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.
Key facts
- Where
- Budapest VIII és Pécs, MagyarországSee the 2 sites
- Phase
- 4. fázis
Where in Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországToborzás még nem indult
- University of PecsPécs, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Semmelweis University
- Trial code
- EU 2025-524501-32-02
- Record updated
- 2026. március 13.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Has a hypersensitivity to Broncho-Vaxom; 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; Patients who are unable to walk enough distance to come to the visit.