12 completed, 3 recruiting, 1 active not recruiting, 1 terminated. 7 Phase 3, 6 Phase 4, 4 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 6, Recruiting 1 |
| Phase 4 | 6 | Completed 3, Recruiting 2, Active not recruiting 1 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Not applicable | 1 | Unknown 1 |
Follow Broncho-Vaxom: new trials by email Literature Review of Broncho-Vaxom trials Research Report on Broncho-Vaxom
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Prevention With Ismigen of RTIs in Kids Bacterial Lysates, Placebo - Respiratory Tract Infections (RTI), Healthy Children | Phase 4 | Recruiting | Lallemand Pharma AG | 224 | 2026-06-01 | 2026-07-08 |
| OM 85 to Prevent Respiratory Infections in Older At Risk Patients Bacterial Lysate, Placebo - Respiratory Tract Infections (RTI) | Phase 4 | Recruiting | Campus Bio-Medico University | 360 | 2025-02-01 | 2025-03-18 |
| OM 85 to Prevent Respiratory Infections in Older At Risk Patients Bacterial Lysate, Placebo - Respiratory Tract Infections (RTI) | Phase 4 | Active not recruiting | Fondazione Policlinico Universitario Campus Bio-Medico | 360 | 2024-12-19 | 2025-09-17 |
| Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates. Broncho-Vaxom, Placebo - Wheezing, LRTI | Phase 3 | Recruiting | Franciscus Gasthuis | 500 | 2022-03-18 | 2026-09-25 |
| Bacterial Lysate In Preventing Asthma Bacterial Lysate - Respiratory Tract Infections, Pediatric Respiratory Diseases | Phase 2 | Completed | Queen Mary University of London | 173 | 2022-01-12 | 2026-05-19 |
| Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD Broncho-Vaxom, Placebo - Atopic Dermatitis | Phase 2 | Terminated | OM Pharma SA | 63 | 2021-12-20 | 2023-08-08 |
| Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome Broncho-Vaxom - Nephrotic Syndrome in Children | Not applicable | Unknown | Fang Deng | 83 | 2021-09-01 | 2021-09-14 |
| The Influence of Nonspecific Immunostimulation on Changes in the Concentration of iNKT Cells Ismigen, Placebo - Allergic Rhinitis Due to Grass Pollen | Phase 3 | Completed | Medical University of Lublin | 80 | 2021-03-22 | 2022-04-05 |
| Reducing Acute Severe Respiratory Events in Health Care Workers During the Covid-19 Pandemic With OM85 Broncho-Vaxom® - Respiratory Viral Infection, Covid19 | Phase 3 | Completed | The University of Queensland | 59 | 2020-08-24 | 2022-03-09 |
| PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study MCT, Clazakizumab, Broncho-Vaxom - Asthma | Phase 2 | Completed | University of North Carolina, Chapel Hill | 950 | 2019-12-19 | 2026-04-01 |
| Efficacy Of Bacterial Lysate In Children With Allergic Rhinitis Ismigen, Placebo - Allergic Rhinitis | Phase 3 | Completed | Medical University of Lublin | 76 | 2018-04-22 | 2021-03-17 |
| Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus Ismigen, Placebo - Allergic Rhinitis | Phase 3 | Completed | Medical University of Lublin | 70 | 2018-04-22 | 2022-04-11 |
| Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness Broncho-Vaxom (BV), Placebo - Asthma, Wheezing | Phase 2 | Completed | University of Arizona | 822 | 2017-01-01 | 2026-06-02 |
| Prevention of OM-85 on Bronchiectasis Exacerbation OM-85 BV - Bronchiectasis With Acute Exacerbation | Phase 4 | Completed | Chinese Academy of Medical Sciences | 196 | 2015-03-01 | 2020-04-21 |
| Efficacy Of Bacterial Lysate In Asthmatic Children ISMIGEN, PLACEBO - Allergic Asthma | Phase 3 | Completed | Lallemand Pharma AG | 150 | 2014-07-01 | 2015-09-07 |
| Advanced Immunological Approach in COPD Exacerbation Placebo, Ismigen - Chronic Obstructive Pulmonary Disease (COPD) | Phase 4 | Completed | Lallemand Pharma AG | 288 | 2009-09-01 | 2015-04-15 |
| Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing OM-85 BV (Broncho-Vaxom), OM-85 BV (placebo) - Asthma | Phase 4 | Completed | Kecioren Education and Training Hospital | 80 | 2007-08-01 | 2014-07-16 |
| Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis Broncho-Vaxom, Placebo - Cap - Atopic Dermatitis | Phase 3 | Completed | Vifor Pharma | 179 | 2003-07-01 | 2017-02-09 |
Respiratory Tract Infections (5) · Respiratory Sounds (4) · Asthma (3) · Rhinitis, Allergic (3) · Rhinitis, Allergic, Seasonal (3) · Dermatitis, Atopic (2) · Bronchiectasis (1) · Bronchiolitis (1) · COVID-19 (1) · Infections (1) · Lymphoma, Follicular (1) · Premature Birth (1) · Pulmonary Disease, Chronic Obstructive (1) · Recurrence (1)
Lallemand Pharma AG (3) · Medical University of Lublin (3) · Campus Bio-Medico University (1) · Chinese Academy of Medical Sciences (1) · Fang Deng (1) · Fondazione Policlinico Universitario Campus Bio-Medico (1) · Franciscus Gasthuis (1) · Kecioren Education and Training Hospital (1) · OM Pharma SA (1) · Queen Mary University of London (1) · The University of Queensland (1) · University of Arizona (1) · University of North Carolina, Chapel Hill (1) · Vifor Pharma (1)
Poland (6) · Italy (3) · Netherlands (2) · United States (2) · Australia (1) · China (1) · France (1) · Germany (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Anastasia Ivanova, PhD (1) · C H Razi, MD (1) · Dave T Mauger, PhD (1) · Fang Deng, PhD.MD. (1) · Fernando D Martinez, MD (1) · Franziska Rueff, Professor (1) · Frederic Durmont, MD (1) · Giorgio Walter Canonica, Prof. MD (1) · Jinming Gao, M.D. (1) · Jonathan Grigg, Prof. Dr (1) · Wayne J Morgan, MD (1) · Yves De Prost, MD (1)
PMID 24773830, PMID 29575037, PMID 32858239, PMID 33472687, PMID 34965026, PMID 36733480, PMID 42705251
2025 (1), U24HL138998 (1)