Actively Recruiting
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).
Led by Laboratorio Farmaceutico SIT srl · Updated on 2025-12-10
240
Participants Needed
10
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide voluntary informed consent and follow study requirements
- Male or female aged 18 to 99 years
- Diagnosed with recurrent lower respiratory tract infections including tracheitis, tracheobronchitis, acute bronchitis, or exacerbations of chronic lung diseases like asthma, COPD, or bronchiectasis
- Experienced at least 2 infection episodes in the 12 months prior to the run-in period based on medical history
- Experienced at least 2 infection episodes during the run-in period confirmed by microbiological tests
- Either not vaccinated or vaccinated within 12 months prior to or during the run-in period (but not during treatment) against common respiratory infection pathogens such as pertussis, Covid-19, RSV, influenza, or pneumococcus
- Patients vaccinated with vaccines unrelated to lower respiratory tract infections (e.g., hepatitis B, shingles, papilloma virus) may also participate
You will not qualify if you...
- Female who is pregnant, lactating, or planning pregnancy during run-in or treatment periods
- Female of child-bearing potential not using at least one effective contraceptive method for the entire study
- Known allergy or contraindication to bacterial lysates or any tablet ingredients
- Pneumonia diagnosis
- History of tuberculosis or cystic fibrosis
- Known immunodeficiency diseases including HIV/AIDS or congenital/iatrogenic immune deficiencies
- Severe heart failure (NYHA class III or IV)
- Severe anemia (hemoglobin < 8.0 g/dL)
- Renal failure with eGFR < 30 mL/min
- Known liver damage classified F1-F4 by METAVIR (with valid documentation)
- History of malignancies with remission less than 5 years
- Wheezing caused by gastroesophageal reflux (confirmed by clinical documentation)
- Legal or mental incapacity preventing informed consent
- Inability or unwillingness to comply with study visits and requirements
- History of autoimmune diseases or acute intestinal infections as per Buccalin4 product information
- Use of steroids within 4 weeks prior to randomization
- Use of immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to randomization
- Prior or ongoing use of bacterial lysates within 6 months prior to randomization
- Major surgery within 3 months prior to randomization
AI-Screening
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Trial Site Locations
Total: 10 locations
1
AOU Ss. Antonio E Biagio E C.Arrigo
Alessandria, Italy
Active, Not Recruiting
2
AOU Policlinico G. Rodolico-San Marco
Catania, Italy
Active, Not Recruiting
3
ASST Fatebenefratelli Sacco
Milan, Italy
Active, Not Recruiting
4
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Active, Not Recruiting
5
ASST Santi Paolo e Carlo
Milan, Italy
Actively Recruiting
6
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Active, Not Recruiting
7
Humanitas Mirasole S.p.A
Milan, Italy
Active, Not Recruiting
8
AOU Policlinico Tor Vergata
Roma, Italy
Active, Not Recruiting
9
AOU di Sassari
Sassari, Italy
Actively Recruiting
10
University clinic for infectious diseases and febrile conditions, Medical Faculty, Ss Cyril and Methodius University
Skopje, North Macedonia
Actively Recruiting
Research Team
S
Silvana Lonetti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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