Broncho-Vaxom (OM-85) / OM Pharma, Optimus Holding, Shanghai Pharma - LARVOL DELTA

OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness (clinicaltrials.gov) - P4 | N=525 | Completed | Sponsor: OM Pharma SA | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pediatrics • Respiratory Diseases

Exploring the Role of Bacterial Lysate OM-85 on Immune Mechanisms in Allergic Asthma (ERS 2026) - "This study shows that OM-85 induces durable immune reprogramming in adults with T2-high asthma, consistent with trained immunity. By reducing inflammation while preserving antiviral and innate-like responses, OM-85 establishes a sustained recalibration of immune surveillance, supporting its further development as a preventive strategy for RTI-associated asthma exacerbations."

Asthma • Immunology • Infectious Disease • Inflammation • Respiratory Diseases • IFNG • IL6

OM-85 attenuates TGF-β–driven fibrotic and Epithelial-Mesenchymal-Transition (EMT) responses in primary airway cells from asthma and COPD patients (ERS 2026) - "OM-85 (Broncho-Vaxom®) is an oral immunomodulator with established protective effects against respiratory infections; however, its impact on airway remodeling remains unclear...In ASMC, OM-85 significantly reduced TGF-β-induced α-SMA expression (p<0.0001). These findings suggest that OM-85 attenuates the TGF-β-induced profibrotic and EMT responses in structural airway cells, highlighting its potential role in limiting airway remodeling in asthma and COPD."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Fibrosis • Immunology • Infectious Disease • Inflammation • Respiratory Diseases • CDH1 • FN1 • TGFB1

Exploring the effects of OM-85 bacterial lysate on paediatric airway epithelial responses to rhinovirus infection (ERS 2026) - "OM-85 (Broncho-Vaxom®), a well-established immunomodulator, has been shown to reduce the severity and frequency of viral induced wheezing attacks... These preliminary findings suggest that OM-85 may influence epithelial responses during RV infection without disrupting barrier integrity. Further studies are required to confirm these effects."

Asthma • Immunology • Infectious Disease • Pediatrics • Respiratory Diseases • ICAM1

PROTEA: Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates. (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Franciscus Gasthuis | Trial completion date: Dec 2026 ➔ Dec 2030 | Trial primary completion date: Dec 2025 ➔ Dec 2029

Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases

Use of the bacterial lysate OM-85 for the primary prevention of wheezing lower respiratory illness in preschool children: a randomised, placebo-controlled trial. (PubMed, Lancet) - P2 | "Oral administration of OM-85 in early life did not decrease the incidence of wheezing lower respiratory tract illness in this high-risk population. Bacterial lysates are not efficacious for the primary prevention of asthma-like symptoms during the preschool years."

Journal • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pulmonary Disease • Respiratory Diseases