Respiratory InfectionPhase 4BUC-01-23NCT06736288
Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).
A Phase 4 study testing BUCCALIN® in people with Respiratory Infection and Lower Respiratory Tract Infection (LRTI), run by Laboratorio Farmaceutico SIT srl at 10 sites in 2 countries.
Trial summary
The goal of this clinical trial is to assess if BUCCALIN® works In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIS). It will also evaluate the safety of BUCCALIN®. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Infection, Lower Respiratory Tract Infection (LRTI)
- What is being tested?
- BUCCALIN®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 21 Oct 2025to Apr 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females from 18 to 99 years old, (Adult, Older Adult).
- Patients with Recurrent LRTIs including tracheitis, tracheobronchitis, acute bronchitis and exacerbations of chronic lung disease (asthma and/or COPD and/or bronchiectasis), who present with both of the following:
- ≥2 episodes within 12 months prior to the run-in period based on patient reported medical history (to access the run-in period) b) ≥2 episodes during the run-in period documented by appropriate microbiological diagnostic test (to access the treatment period)
- Patients:
- not vaccinated or
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- vaccinated against the most common pathogens for respiratory infectioan (within 12 months prior to the run-in period or during the run-in period, but not during the treatment period)*:
- Anti-pertussis vaccination
- Covid-19 vaccination
- Respiratory Syncytial Virus vaccination
- Influenza vaccination
- Pneumococcal vaccination
- Patients vaccinated with other types of vaccines that have no effect on the lower respiratory tract (e.g. hepatitis b vaccination, shingles/herpes zoster vaccination, papilloma virus vaccine), in addition to the ones listed above, may also be included.
Who cannot join
- RUN-IN period
- Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).
- Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.
- Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465).
- Known history of tuberculosis and/or cystic fibrosis.
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- Known history of immunodeficiency diseases (e.g., HIV infection, AIDS, or any type of congenital or iatrogenic immune deficiency, including IgA deficiency).
- Severe heart failure (NYHA class III and IV).
- Haematologic diseases including severe anaemia (defined according to the National Cancer Institute as Hemoglobin < 8.0 g/dL).
- Renal failure (eGFR < 30 mL/min).
- History of known liver damages defined by the METAVIR classification (F1-F4)*.
- Malignancies with a remission period of < 5 years.
- Wheezing documented to be caused by gastroesophageal reflux**.
- Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
- Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
- History of autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC.
- This criterion only applies to patients with known liver disease who can produce valid fibroscan and/or biopsy results and bring them for demonstration.
- The criterion can only be applied if the patient presents clinically reliable documentation that the wheezing is not due to a lung disease (i.e. gastroscopy).
- TREATMENT period
- Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).
- Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.
- Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465).
- Known history of tuberculosis and/or cystic fibrosis.
- Known history of immunodeficiency diseases (e.g., HIV infection, AIDS, or any type of congenital or iatrogenic immune deficiency, including IgA deficiency).
- Severe heart failure (NYHA class III and IV).
- Haematologic diseases including severe anaemia (defined according to the National Cancer Institute Hemoglobin < 8.0 g/dL).
- Renal failure (eGFR < 30 mL/min).
- History of known liver damages defined by the METAVIR classification (F1-F4)*.
- Malignancies with a remission period of < 5 years.
- Injection or oral administration of steroids within 4 weeks prior to randomization**.
- Use of immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to randomization.
- Previous use within 6 months prior to randomization or ongoing use of bacterial lysates.
- Any major surgery within the last 3 months prior to randomization.
- Wheezing documented to be caused by gastroesophageal reflux***.
- Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
- Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
- History of autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC.
- This criterion only applies to patients with known liver disease who can produce valid fibroscan and/or biopsy results and bring them for demonstration.
- In these instances, patients may undergo a washout period of 4 weeks to qualify for the treatment period.
- The criterion can only be applied if the patient presents clinically reliable documentation that the wheezing is not due to a lung disease (i.e. gastroscopy).
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Italy9 sites, 2 recruiting
- Active, not recruiting
AOU Ss. Antonio E Biagio E C.Arrigo
Alessandria
- Active, not recruiting
AOU Policlinico G. Rodolico-San Marco
Catania
- Active, not recruiting
ASST Fatebenefratelli Sacco
Milan
- Active, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan
- Recruiting
ASST Santi Paolo e Carlo
Milan
- Active, not recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
- Active, not recruiting
Humanitas Mirasole S.p.A
Milan
- Active, not recruiting
AOU Policlinico Tor Vergata
Roma
- Recruiting
AOU di Sassari
Sassari
North Macedonia1 site, 1 recruiting
- Recruiting
University clinic for infectious diseases and febrile conditions, Medical Faculty, Ss Cyril and Methodius University
Skopje
About this study
Official title: Randomized, Double Blind, Placebo Controlled, Two-Arms, Multicenter, Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).
The goal of this clinical trial is to assess if BUCCALIN® works In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIS). It will also evaluate the safety of BUCCALIN®.
The primary aim is to reduce the number of infection episodes in the treatment period (12 months) in the BUCCALIN® group versus the Placebo group.
Read more
Patients diagnosed with RLRTIS will be screened for enrolment. Patients will be requested to provide informed consent before the start of the study related assessments.
Eligible patients who meet the study inclusion and exclusion criteria will be randomized with a 1:1 ratio allocation to the 2 treatment groups.
Researchers will compare BUCCALIN® (gastro-resistant tablets) to a placebo (gastro-resistant tablets containing only excipients) to treat RLRTIS.
Patients who participate in the study will perform several study visits divided as reported below:
- Run-in phase (12 months): patients will not receive any treatment. This phase is designed to increase adherence to the study and reduce loss to follow-up in the clinical trial. During this phase, patients should experience ≥ 2 episodes of RTIs to be eligible for the Treatment period.
- Treatment period (12 months): patients will receive BUCCALIN® or Placebo treatment for 12 consecutive months (3 days per month, posology as per authorized SmPC).
- Follow-up period (12 months): patients will not receive any treatment. This phase is designed to observe how patients respond to treatments.
- Being tested
- BUCCALIN®, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUCCALIN®Drug
Gastro-resistant tablets (mixture of Streptococcus pneumoniae I, II, III, Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae).
The recommended dosage is 1 tablet on day 1, 2 tablets on day 2, and 4 tablets on day 3 and should be taken in the morning on an empty stomach.
PlaceboOther
Gastro-resistant tablets containing only excipients). The recommended dosage is 1 tablet on day 1, 2 tablets on day 2, and 4 tablets on day 3 and should be taken in the morning on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| BUCCALIN® gastro-resistant tablets | Active comparator | mixture of Streptococcus pneumoniae I, II, III, Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae Receives: Drug: BUCCALIN® |
| Placebo | Placebo comparator | gastro-resistant tablets containing only excipients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RLRTIs Episodes: Reduction in the number of infection episodes in the treatment period (12 months) in the Buccalin® group versus the Placebo group.
Measured: From the enrollment to the end of the treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start21 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorio Farmaceutico SIT srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736288
- Sponsor's protocol ID
- BUC-01-23
- Other IDs
- 2024-512937-34-00
- Acronym
- BUC-01-23
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled, Two-Arms, Multicenter, Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).
- ClinicalTrials.gov ID
- NCT06736288
- Acronym / sponsor ID
- BUC-01-23 / BUC-01-23
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Laboratorio Farmaceutico SIT srlIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess if BUCCALIN® works In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIS). It will also evaluate the safety of BUCCALIN®.
The primary aim is to reduce the number of infection episodes in the treatment period (12 months) in the BUCCALIN® group versus the Placebo group.
Patients diagnosed with RLRTIS will be screened for enrolment. Patients will be requested to provide informed consent before the start of the study related assessments.
Eligible patients who meet the study inclusion and exclusion criteria will be randomized with a 1:1 ratio allocation to the 2 treatment groups.
Researchers will compare BUCCALIN® (gastro-resistant tablets) to a placebo (gastro-resistant tablets containing only excipients) to treat RLRTIS.
Patients who participate in the study will perform several study visits divided as reported below:
- Run-in phase (12 months): patients will not receive any treatment. This phase is designed to increase adherence to the study and reduce loss to follow-up in the clinical trial. During this phase, patients should experience ≥ 2 episodes of RTIs to be eligible for the Treatment period.
- Treatment period (12 months): patients will receive BUCCALIN® or Placebo treatment for 12 consecutive months (3 days per month, posology as per authorized SmPC).
- Follow-up period (12 months): patients will not receive any treatment. This phase is designed to observe how patients respond to treatments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUCCALIN® gastro-resistant tablets | Active comparator | Drug: BUCCALIN®mixture of Streptococcus pneumoniae I, II, III, Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae |
| Placebo | Placebo comparator | Other: Placebogastro-resistant tablets containing only excipients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females from 18 to 99 years old, (Adult, Older Adult).
- Patients with Recurrent LRTIs including tracheitis, tracheobronchitis, acute bronchitis and exacerbations of chronic lung disease (asthma and/or COPD and/or bronchiectasis), who present with both of the following:
- Patients:
Key exclusion criteria (41 listed)
- RUN-IN period
- Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).
- Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.
- Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BUCCALIN®Gastro-resistant tablets (mixture of Streptococcus pneumoniae I, II, III, Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae). The recommended dosage is 1 tablet on day 1, 2 tablets on day 2, and 4 tablets on day 3 and should be taken in the morning on an empty stomach. | Drug | BUCCALIN® gastro-resistant tablets |
| PlaceboGastro-resistant tablets containing only excipients). The recommended dosage is 1 tablet on day 1, 2 tablets on day 2, and 4 tablets on day 3 and should be taken in the morning on an empty stomach. | Other | Placebo |
Primary outcome
RLRTIs Episodes: Reduction in the number of infection episodes in the treatment period (12 months) in the Buccalin® group versus the Placebo group.
Time frame: From the enrollment to the end of the treatment at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BUCCALIN® in people with Respiratory Infection and Lower Respiratory Tract Infection (LRTI), run by Laboratorio Farmaceutico SIT srl at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvana Lonetti (+39 0384 8071, s.lonetti@sit-farmaceutici.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RLRTIs Episodes: Reduction in the number of infection episodes in the treatment period (12 months) in the Buccalin® group versus the Placebo group. (time frame: From the enrollment to the end of the treatment at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.