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The prevention of respiratory tract infections offered by oral administration of the bacterial lysate-OM-85 is extended to asthma symptoms, exacerbations, and need for oral corticosteroids

Remission outcomes in severe T2-high asthma with bacterial lysate OM-85 therapy: analysis of the OMRIA study

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN72336993
Enrollment
100
Registered
2025-12-16
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe bronchial asthma Respiratory

Interventions

Post hoc analysis of the OMRIA RWE study (https://doi.org/10.2147/jaa.s517194). In this analysis, the researchers used a four-component clinical-remission definition. Patients were required to meet al
ii) exacerbation-free
iii) ACT =20
and iv) no worsening from baseline in pre-bronchodilator FEV1. The researchers checked both the medical records of the patients and the e-prescription system of the National Health System of Greece.

Sponsors

Asthma Clinics Specialist Care Practices Greece
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients =18 years of age 2. A clinical diagnosis of moderate to severe uncontrolled bronchial asthma, despite standard of care (SoC) asthma therapy (appropriate addressing of comorbidities and treatable traits, as well as adherence to GINA step 4 asthma therapy) 3. Patients were required to meet all of the following criteria at the end of the 12-month observational period in order to achieve the clinical remission definition: 3.1. Oral corticosteroid (OCS)-free 3.2. Exacerbation-free 3.3. Asthma Control Test (ACT) =20 3.4. No worsening from baseline in pre-bronchodilator FEV1 4. Have relevant medical records within the prior 12 months

Exclusion criteria

Exclusion criteria: Need for maintenance oral corticosteroids (mOCS) for causes other than asthma

Countries

Greece

Contacts

Public ContactAntonios Christopoulos
asthmaclinics@outlook.com+30 (0)6977983808

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026