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
| ISRCTN | ISRCTN72336993 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72336993 |
| Sponsor | Asthma Clinics Specialist Care Practices Greece |
| Funder | Asthma Clinics Specialist Care Practices Greece |
- Submission date
- 23/11/2025
- Registration date
- 16/12/2025
- Last edited
- 16/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Synergistic interactions between allergen sensitization, allergen exposure, and viral infection are detected in asthmatics during exacerbations. This study assessed the effect of the polyvalent chemical bacterial lysate OM-85 on reducing the risk of exacerbations and oral corticosteroids (OCS) use in adults with allergic asthma.
Who can participate?
Patients aged 18 years and over with moderate to severe bronchial asthma who remain uncontrolled despite adherence to standard of care asthma therapy
What does the study involves?
Two 3-month treatment courses of co-administration of OM-85. The researchers assessed the medical records of the patients and the e-prescription system of the National Health System of Greece to determine the proportion of patients meeting the definitions of clinical remission at the end of the 12-month observation.
What are the possible benefits and risks for participating?
Patients treated with OM-85 could improve their asthma control and meet the goals of clinical remission on treatment at the end of the 12-month follow-up. Patients will continue in parallel the standard of care treatment. OM-85 is a well-studied treatment option, approved and available in many countries all over the world, without signals for serious adverse events and/or side effects.
Where is the study run from?
The study was conducted in specialist care practices in Greece (Athens, Patra and Kalavryta)
When is the study starting and how long is it expected to run for?
December 2025 to February 2026
Who is funding the study?
Asthma Clinics Specialist Care Practices (Greece)
Who is the main contact?
Dr Antonios Christopoulos, asthmaclinics@outlook.com
Contact information
Principal investigator, Scientific, Public
Mezonos Str 61-63 Patras/gr
Kyriazi 36 Kifisia
Patra
26221
Greece
| Phone | +30 (0)6977983808 |
|---|---|
| asthmaclinics@outlook.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Remission outcomes in severe T2-high asthma with bacterial lysate OM-85 therapy: analysis of the OMRIA study |
| Study objectives | The aim of our analysis was to demonstrate that clinical remission on-treatment is a realistic target in difficult-to-treat, moderate to severe T2-high asthma, for those patients treated additionally with the bacterial lysate OM-85. |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | Severe bronchial asthma |
| Intervention | 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 all of the following criteria at the end of the 12-month observational period: i) OCS-free; 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. A post hoc analysis was performed to determine the proportion of patients meeting the individual components of the clinical remission definitions and to appreciate the individual contribution of each component at the end of the 12-month observation. A descriptive analysis of differences in the baseline demographics and clinical characteristics of patients according to their remission status at the end of the observation (i.e. those who met the clinical remission definition compared with those who did not) was also performed to gain insight into the responsive population. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bacterial Lysate OM-85 (PHARMA) |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 15/02/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 137 |
| Key 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 |
| Key exclusion criteria | Need for maintenance oral corticosteroids (mOCS) for causes other than asthma |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- Greece
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
02/12/2025: Study's existence confirmed by Asthma Clinics Specialist Care Practices Greece.
