Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
360
Countries
1
Sites
1
Elderly patients with a positive history of at least two respiratory system infections in the year preceding enrollment and residents for at least 6 months in a Healthcare Residence.
To evaluate whether and to what extent OM85 compared to placebo is able to reduce Respiratory Tract Infections (RTIs) in a period of 12 months in a population of elderly subjects, residing in Healthcare Residence, and with a history of at least two respiratory tract infections in the 12 months before enrollment.
Key facts
- Sponsor
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 19 Dec 2024 → ongoing
- Decision date (initial)
- 2024-09-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- OMPharma SA
External identifiers
- EU CT number
- 2024-513592-41-00
- WHO UTN
- U1111-1306-8882
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Prophylaxis
To evaluate whether and to what extent OM85 compared to placebo is able to reduce Respiratory Tract Infections (RTIs) in a period of 12 months in a population of elderly subjects, residing in Healthcare Residence, and with a history of at least two respiratory tract infections in the 12 months before enrollment.
Secondary objectives 4
- Verify whether the rate of hospital admissions and emergency room visits due to RTI decreases in the OM85 group more than in placebo group having the year before the intervention as reference.
- To evaluate antibiotic prescriptions in the two groups (OM85 and placebo) during the 12 months of the study.
- Define the demographic, clinical and functional profile of the patient at risk of RTI.
- Evaluate the incidence of adverse drug reactions (TEAEs).
Conditions and MedDRA coding
Elderly patients with a positive history of at least two respiratory system infections in the year preceding enrollment and residents for at least 6 months in a Healthcare Residence.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10038133 | Recurrent respiratory tract infections | 10021881 |
| 20.0 | HLGT | 10024970 | Respiratory tract infections | 10038738 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Total duration of treatment Patients will receive two consecutive 3-month cycles of OM85/placebo. The total duration of treatment will be 6 months.
|
Randomised Controlled | Double | [{"id":169965,"code":3,"name":"Monitor"},{"id":169964,"code":1,"name":"Subject"},{"id":169963,"code":5,"name":"Carer"},{"id":169962,"code":4,"name":"Analyst"},{"id":169961,"code":2,"name":"Investigator"}] | OM85: 180 patients, randomly selected, will receive two consecutive 3-month cycles of OM85, one 7 mg capsule every morning on an empty stomach for the first 10 days of each month. Placebo: 180 patients, randomly selected, will receive two consecutive 3-month cycles of placebo, one 7 mg capsule every morning on an empty stomach for the first 10 days of each month. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Age 75 years or older.
- 2. At least 2 RTIs in the year preceding enrollment.
- 3. Patients must have resided in the Healthcare Residence for at least 6 months and have an expected stay in the Healthcare Residence of at least 6 months according to the physician judgement
- 4. Signed informed consent. For participants unable to provide informed consent due to cognitive deficits, consent will be provided by a legally recognized representative or a patient trustee (pursuant to article 4 of law 22 December 2017, n. 219).
- 5. Have a life expectancy of at least one year according to the physician judgement.
Exclusion criteria 8
- 1. Patients with known allergy or previous intolerance to the study drug
- 2. Patients with active neoplasm and prognosis of less than one year
- 3. Patients with previous organ transplant
- 4. Patients treated with the following drugs: immunosuppressive or immunostimulatory therapy in the 3 months before the start of the study
- 5. Patients who have taken bacterial lysates in the 6 months prior to enrollment or who are currently using them
- 6. Patients treated regularly with oral corticosteroids
- 7. Patients who are unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements).
- 8. Patients with any other clinical condition that, in the opinion of the investigator, would not allow the protocol to be completed and the study drugs to be administered safely.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The measured variable will be the number of respiratory tract infections (RTIs) in the two groups during the treatment period (6 months) and until the end of the observation period (further 6 months) after the start of administration of OM 85 or placebo.
Secondary endpoints 3
- rate of hospital admissions and emergency room visits in the 12 months following the start of the intervention in the OM 85 or placebo group
- consumption of antibiotics in the 12 months following the start of the intervention
- evaluation of the incidence of adverse events of OM-85 in elderly patients at risk by reviewing medical records
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
BRONCHO VAXOM Adulti 7 mg capsule rigide
PRD9873824 · 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 USE
- Max daily dose
- 7 mg milligram(s)
- Max total dose
- 420 mg milligram(s)
- Max treatment duration
- 60 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AX — OTHER BACTERIAL VACCINES
- Marketing authorisation
- 026029013
- MA holder
- OMEDICAMED UNIPESSOAL LDA
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Same form and composition of the drug, except for the 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
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Sponsor organisation
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Address
- Via Alvaro Del Portillo N 200
- City
- Rome
- Postcode
- 00128
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Contact name
- Prof. Raffaele Antonelli Incalzi
Public contact point
- Organisation
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Contact name
- Prof. Raffaele Antonelli Incalzi
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| G.A.29 S.r.l. ORG-100051533
|
Lamezia Terme, Italy | Other |
| Paob S.r.l. ORG-100051535
|
Catanzaro, Italy | Other |
| R.S.A. La Quiete S.r.l. ORG-100051549
|
Castiglione Cosentino, Italy | Other |
| Villa Santo Stefano S.r.l. ORG-100051544
|
Santo Stefano Di Rogliano, Italy | Other |
| Salus S.r.l. ORG-100051591
|
Isola Del Liri, Italy | Other |
| Provincia Romana Dell'Ordine Dei Chierici Regolari Ministri Degl Infermi ORG-100051661
|
Rome, Italy | Other |
| Alpha Service S.r.l. ORG-100051534
|
Catanzaro, Italy | Other |
| Casa Gen.Zia Del Pio Istituto Piccole Suore Della Sacra Famiglia ORG-100051596
|
Verona, Italy | Other |
| Sogepi S.r.l. ORG-100051581
|
Sant'Elia Fiumerapido, Italy | Other |
| San Germano S.r.l. ORG-100051597
|
Piedimonte San Germano, Italy | Other |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 360 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-12-19 | 2024-12-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-513592-41-00 | 8 |
| Protocol (for publication) | D1_ Protocol 2024-513592-41-00_ENG TC redacted | 8 |
| Protocol (for publication) | D1_ Protocol 2024-513592-41-00_ITA TC redacted | 8 |
| Protocol (for publication) | D1_Protocol 2024-513592-41-00_ENG | 8 |
| Protocol (for publication) | D1_Summary of Changes_NSM-2_2024-513592-41-00 | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults | 6 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults TC | 6 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF privacy | 4.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_GPL | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC OM85 BRONCHO VAXOM | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC OM85 BRONCHO VAXOM_ENG | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ITA_2024-513592-41-00 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-513592-41-00_ENG TC | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-513592-41-00_ITA TC | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-513592-41-00 | 7 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-30 | Italy | Acceptable 2024-09-16
|
2024-09-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-07 | Italy | Acceptable 2024-09-16
|
2024-10-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-05 | Italy | Acceptable 2024-09-16
|
2026-02-05 |