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).

Launched by LABORATORIO FARMACEUTICO SIT SRL · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called BUCCALIN® to see if it helps prevent recurrent lower respiratory tract infections (RLRTIs), which are repeated infections affecting the lungs and airways. The trial aims to find out if patients who take BUCCALIN® experience fewer infection episodes compared to those who receive a placebo (a dummy treatment that does not contain the active medication).

To be eligible for this trial, participants must be between 18 and 99 years old and have had at least two episodes of lower respiratory tract infections in the past year. They should not be pregnant or planning to become pregnant, and they should not have certain other serious health conditions. If someone chooses to participate, they will go through three phases: a 12-month period without treatment to help ensure they qualify, a 12-month treatment period where they will take BUCCALIN® or the placebo, and finally a 12-month follow-up period to observe their health after treatment. This study is not yet recruiting participants, but it will gather important information about the effectiveness and safety of BUCCALIN® for patients with recurrent respiratory infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
• • 2. Male or females from 18 to 99 years old, (Adult, Older Adult).
• • 3. Patients with Recurrent LRTIs (≥2 episodes of RTIs within 12 months prior the run-in phase and during the run-in phase), based on medical recording or reported history. RLRTIs will include acute bronchitis, and exacerbations of chronic lung disease (asthma and/or COPD and/or bronchiectasis).
• 4. Patients not vaccinated and/or vaccinated with specific vaccination against the most common pathogens for respiratory infection\*:
• • Anti-pertussis vaccination
• • Covid-19 vaccination
• • Respiratory Syncytial Virus vaccination
• • Influenza vaccination
• • Pneumococcal vaccination
• • 5. Patients vaccinated with other types of vaccine, e.g. hepatitis b vaccination, shingles/herpes zoster vaccination, papilloma virus vaccine.
• • 6. RLRTIs documented by appropriate microbiological diagnostic test.
• • Any all the above vaccination are accepted within 12 months prior to the run-in phase and during the run-in phase.
• Exclusion Criteria:
• • 1. Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).
• • 2. Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
• • 3. Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.
• • 4. Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465).
• • 5. Respiratory diseases of infectious of any other origin (tuberculosis, cystic fibrosis).
• • 6. HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
• • 7. Severe heart failure (NYHA class III and IV).
• • 8. Haematologic diseases excluding mild to moderate anaemia (defined according to the National Cancer Institute as follows: Mild: Hemoglobin 10.0 g/dL to lower limit of normal. Moderate: Hemoglobin 8.0 to 10.0 g/dL).
• • 9. Renal failure (eGFR \< 30 mL/min).
• • 10. Liver damages defined by the METAVIR classification (F0-F2).
• • 11. Malignancies with a remission period of \< 5 years.
• • 12. Injection or oral administration of steroids within 4 weeks prior to study enrolment.
• • 13. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
• • 14. Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
• • 15. Any major surgery within the last 3 months prior to study enrolment.
• • 16. Wheezing documented to be caused by gastroesophageal reflux.
• • 17. Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
• • 18. Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
• • 19. Autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC.