LYOPHILIZED BACTERIAL LYSATES OF: HAEMOPHILUS INFLUENZAE STREPTOCOCCUS (DIPLOCOCCUS) PNEUMONIAE KLEBSIELLA PNEUMONIAE AND OZAENAE STAPHYLOCOCCUS AUREUS STREPTOCOCCUS PYOGENES AND VIRIDANS MORAXELLA (BRANHAMELLA / NEISSERIA) CATARRHALIS for COPD exacerbation|Chronic obstructive pulmonary disease exacerbation

Inclusion criteria

• {"criterion_text":"- Has confirmed diagnosis of COPD.\n- The participant provides documented informed consent/assent for the study.\n- 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\n- FEV1>20%pred and FEV1<70%pred\n- BMI: 18 kg/m2 – 40 kg/m2\n- Female and male patients between 40 years and 80 years.\n- Heavy smoking anamnesis: >20 years smoking history\n- Not reversible <12%pred FEV1 with reversibility test\n- Male participants agree to use contraception method through the study conduct\n- Contraceptive use by women and men should be consistent with local regulation regarding the methods of contraception for those participating in studies."}

Exclusion criteria

• {"criterion_text":"- Patients with inadequate compliance with standard therapies for COPD.\n- Patients who are unable to walk enough distance to come to the visit.\n- Patients who take immunosuppressants or oral corticosteroids within 1 month before entering the study.\n- Patients who take antibiotics within 4 weeks before entering the study.\n- Patients who take bacterial lysate in the previous 12 months at least 4 weeks before entering the study.\n- Has a hypersensitivity to Broncho-Vaxom.\n- 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."}

Primary endpoints

• {"endpoint_text":"- Reduction of the number of moderate (to be treated at home) and severe (hospital) exacerbations at 12 months.","definition_or_measurement_approach":"Count of moderate exacerbations (managed at home) and severe exacerbations (requiring hospitalization) measured at 12 months; primary objective evaluates reduction in rate of moderate and severe exacerbations over 12 months (6-month treatment + 6-month observation)."}

Secondary endpoints

• {"endpoint_text":"- • Reduction of RTIs (patient-reported) • Adverse Event (AE) • Study discontinuation due to AEs","definition_or_measurement_approach":"Patient-reported respiratory tract infections (RTIs); recording of adverse events (AEs) and study discontinuations due to AEs as safety outcomes."}
• {"endpoint_text":"- • Assessment if COPD exacerbations were triggered by RTIs","definition_or_measurement_approach":"Assessment of whether recorded COPD exacerbations are associated with respiratory tract infections."}
• {"endpoint_text":"- • Improvement in 6MWD compared at baseline and end of study","definition_or_measurement_approach":"Six-minute walk distance (6MWD) measured at baseline and at end of study; comparison of change."}
• {"endpoint_text":"- • Improvement of dyspnoe compared at baseline and end of study mMRC scale results.","definition_or_measurement_approach":"mMRC dyspnoea scale scores recorded at baseline and end of study; comparison of change."}
• {"endpoint_text":"- • Reduction of COPD associated symptoms by Broncho-Vaxom • body plethysmography • diffusion capacity test (FEV 1, FVC, FEV 1/FVC, TLC, VC, FRC, RV, DL, CO) • Omron BF511 (mainly fat-free body mass) • CAT-COPD Assessment Test • CCQ-Chronic COPD Questionnaire","definition_or_measurement_approach":"Multiple physiological and patient-reported measures: body plethysmography and diffusion capacity tests (FEV1, FVC, FEV1/FVC, TLC, VC, FRC, RV, DL, CO); body composition measured (Omron BF511); quality of life measured by CAT; symptoms and activity by CCQ."}

Hungary

Earliest CTIS Part Ii Submission Date

02-03-2026

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

11

Number Of Sites

2

Number Of Participants

260

Primary sponsor

Full Name

Semmelweis University

Organisation Type

Educational Institution

Country Of Registered Address

Hungary

Co-sponsors

• University Of Pecs