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.

2025-524501-32-02 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 260
Countries 1
Sites 2

COPD exacerbation

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.

Key facts

Sponsor
Semmelweis University, University Of Pecs
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Decision date (initial)
2026-03-13
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Semmelweis University

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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.

Secondary objectives 5

  1. To evaluate the safety and efficacy of Broncho-Vaxom in reducing RTIs (patient-reported)
  2. To assess if COPD exacerbations were triggered by RTIs.
  3. To evaluate the safety and efficacy of Broncho-Vaxom in 6MWD.
  4. To assess dyspnoe with mMRC dyspnoe scale.
  5. To investigate the exacerbation-reducing effect of bacterial lysate (Broncho-Vaxom) over the 12-month period on exacerbation-related: o respiratory function changes o immune status (IgA, IgG) o body composition o quality of life (CAT-COPD Assessment Test) o physical activity (CCQ-Chronic COPD Questionnaire)

Conditions and MedDRA coding

COPD exacerbation

VersionLevelCodeTermSystem organ class
28.0 LLT 10010953 COPD exacerbation 10038738

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 A Randomized, Multicenter, Double-blind ISS based on SoC
A Randomized, Multicenter, Double-blind Investigator Initiated Clinical Study based on Standard of Care
 Randomised Controlled Double [{"id":168899,"code":2,"name":"Investigator"},{"id":168902,"code":5,"name":"Carer"},{"id":168900,"code":1,"name":"Subject"},{"id":168901,"code":3,"name":"Monitor"}] Arm A: Participants will receive Broncho-Vaxom for 10 days per month over a 6-month treatment phase, followed by a 6-month observation phase.
Arm B: Participants will receive Placebo for 10 days per month over a 6-month treatment phase, followed by a 6-month observation phase.

Regulatory references

Plan to share IPD
No
IPD plan description
N/A
EU CT numberTitleSponsor
2025-524501-32-00 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. Semmelweis University
2025-524501-32-01 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. Semmelweis University

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. Has confirmed diagnosis of COPD.
  2. 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
  3. FEV1>20%pred and FEV1<70%pred
  4. BMI: 18 kg/m2 – 40 kg/m2
  5. Female and male patients between 40 years and 80 years.
  6. Heavy smoking anamnesis: >20 years smoking history
  7. Not reversible <12%pred FEV1 with reversibility test
  8. Male participants agree to use contraception method through the study conduct
  9. Contraceptive use by women and men should be consistent with local regulation regarding the methods of contraception for those participating in studies.
  10. The participant provides documented informed consent/assent for the study.

Exclusion criteria 7

  1. Patients with inadequate compliance with standard therapies for COPD.
  2. Patients who are unable to walk enough distance to come to the visit.
  3. Patients who take immunosuppressants or oral corticosteroids within 1 month before entering the study.
  4. Patients who take antibiotics within 4 weeks before entering the study.
  5. Patients who take bacterial lysate in the previous 12 months at least 4 weeks before entering the study.
  6. Has a hypersensitivity to Broncho-Vaxom.
  7. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Reduction of the number of moderate (to be treated at home) and severe (hospital) exacerbations at 12 months.

Secondary endpoints 5

  1. • Reduction of RTIs (patient-reported) • Adverse Event (AE) • Study discontinuation due to AEs
  2. • Assessment if COPD exacerbations were triggered by RTIs
  3. • Improvement in 6MWD compared at baseline and end of study
  4. • Improvement of dyspnoe compared at baseline and end of study mMRC scale results.
  5. • 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Broncho-Vaxom OM kemény kapszula felnőtteknek

PRD9756915 · Product

Active substance
Lyophilized Bacterial Lysates of: Haemophilus Influenzae Streptococcus (Diplococcus) Pneumoniae Klebsiella Pneumoniae and Ozaenae Staphylococcus Aureus Streptococcus Pyogenes and Viridans Moraxella (Branhamella / Neisseria) Catarrhalis
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
R07AX — OTHER RESPIRATORY SYSTEM PRODUCTS
Marketing authorisation
OGYI-T-9751/01
MA holder
OMEDICAMED UNIPESSOAL LDA
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Powder without active ingredient.

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Semmelweis University

13 Total trials 3 Recruiting 1 Ended
Commercial
Sponsor organisation
Semmelweis University
Address
Tomo Utca 25-29
City
Budapest VIII
Postcode
1083
Country
Hungary

Scientific contact point

Organisation
Semmelweis University
Contact name
Janos Tamas Varga MD

Public contact point

Organisation
Semmelweis University
Contact name
Janos Tamas Varga MD

University Of Pecs

4 Total trials 2 Recruiting
Commercial
Sponsor organisation
University Of Pecs
Address
Rakoczi Ut 2
City
Pecs
Postcode
7623
Country
Hungary

Scientific contact point

Organisation
University Of Pecs
Contact name
Szilvia Soos MD

Public contact point

Organisation
University Of Pecs
Contact name
Szilvia Soos MD

Sponsor responsibilities

Article 77 compliance
Semmelweis University
Contact point sponsor
Semmelweis University
Article 77 implementation
Semmelweis University

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Hungary Authorised, recruitment pending 260 2
Rest of world — 0 —

Investigational sites

Hungary

2 sites · Authorised, recruitment pending
University Of Pecs
Pulmology Clinic, Rakoczi Ut 2, 7623, Pecs
Semmelweis University
Pulmonolgy Department, Tomo Utca 25-29, 1083, Budapest VIII

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) COPD-OM85 Protocol_12Aug2025_updated_27Jan2026_clean 1
Protocol (for publication) COPDOM85 Protocol_12Aug2025_updated_27Jan2026_tracked changes 1
Recruitment arrangements (for publication) COPDOM85 Protocol 1
Subject information and informed consent form (for publication) COPD-OM85_BETEGKARTYA_nevjegy formatumban 1
Subject information and informed consent form (for publication) COPD-OM85_Tajekoztatason alapulo beleegyezo nyilatkozat_clean 1
Subject information and informed consent form (for publication) COPD-OM85_Tajekoztatason alapulo beleegyezo nyilatkozat_tracked changes 1
Summary of Product Characteristics (SmPC) (for publication) Broncho-Vaxom_SmPC 1
Synopsis of the protocol (for publication) COPDOM85 Synopsis 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-01-30 Hungary Acceptable
2026-03-12
 2026-03-13