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).

NCT06736288 | Recruiting Phase 4

• 2 other identifiers: BUC-01-232024-512937-34-00
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 10

Brief 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®. 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.

Conditions

Respiratory Infection; Lower Respiratory Tract Infection (LRTI)

Outcome Measures

Primary Outcomes (1)

• RLRTIs Episodes: Reduction in the number of infection episodes in the treatment period (12 months) in the Buccalin® group versus the Placebo group.

  From the enrollment to the end of the treatment at 24 months

Study Arms (2)

BUCCALIN® gastro-resistant tablets

ACTIVE COMPARATOR

mixture of Streptococcus pneumoniae I, II, III, Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae

Drug: BUCCALIN®

Placebo

PLACEBO COMPARATOR

gastro-resistant tablets containing only excipients

Other: Placebo

Interventions

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.

BUCCALIN® gastro-resistant tablets

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• a) ≥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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorio Farmaceutico SIT srl: lead

Study Sites (10)

AOU Ss. Antonio E Biagio E C.Arrigo

Alessandria, Italy

ACTIVE NOT RECRUITING

AOU Policlinico G. Rodolico-San Marco

Catania, Italy

ACTIVE NOT RECRUITING

ASST Fatebenefratelli Sacco

Milan, Italy

ACTIVE NOT RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

ACTIVE NOT RECRUITING

ASST Santi Paolo e Carlo

Milan, Italy

RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

ACTIVE NOT RECRUITING

Humanitas Mirasole S.p.A

Milan, Italy

ACTIVE NOT RECRUITING

AOU Policlinico Tor Vergata

Roma, Italy

ACTIVE NOT RECRUITING

AOU di Sassari

Sassari, Italy

RECRUITING

University clinic for infectious diseases and febrile conditions, Medical Faculty, Ss Cyril and Methodius University

Skopje, North Macedonia

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

buccalin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Central Study Contacts

Silvana Lonetti

CONTACT

+39 0384 8071; s.lonetti@sit-farmaceutici.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 16, 2024
• Study Start: October 21, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); IT (9)