Actively Recruiting
Randomized, Double Blind, Placebo Controlled, Two-Arms, Multicenter Study to Confirm and Collect More Data on BUCCALIN4 Tablets for Preventing Recurrent Lower Respiratory Tract Infections (RLRTIs)
Led by Laboratorio Farmaceutico SIT srl · Updated on 2025-12-10
240
Participants Needed
10
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BUCCALIN4 gastro-resistant tablets to see if they can help prevent recurrent lower respiratory tract infections (RLRTIs) and to evaluate the safety of this treatment. The main goal is to reduce the number of infection episodes during a 12-month treatment period compared to a placebo group. This phase 4 clinical trial includes adults aged 18 to 99 years who have experienced repeated respiratory infections and meet specific criteria for participation. The study has three phases over a total of 36 months. It starts with a 12-month run-in phase where patients receive no treatment to monitor infection episodes and improve adherence. Patients experiencing at least two infection episodes during this time may enter the 12-month treatment phase, where they receive either BUCCALIN4 tablets or placebo tablets. The medication is taken for 3 days each month in a specific dosage schedule. After treatment, there is a 12-month follow-up phase with no treatment to observe ongoing effects. Throughout the study, participants will attend several visits for assessment. Researchers will monitor infection episodes and safety outcomes from enrollment through the end of the treatment phase. The primary measurement is the number of infection episodes during the 12-month treatment. The study also tracks adherence and collects clinical data during the run-in, treatment, and follow-up phases to evaluate the overall impact of BUCCALIN4 compared to placebo.
CONDITIONS
Brief 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...
- Patients willing and able to provide voluntary informed consent and follow protocol requirements
- Male or female aged 18 to 99 years
- Diagnosis of recurrent lower respiratory tract infections, including tracheitis, tracheobronchitis, acute bronchitis, or exacerbations of asthma, COPD, or bronchiectasis
- At least 2 infection episodes within 12 months before the run-in period based on medical history
- At least 2 infection episodes during the 12-month run-in period confirmed by microbiological tests
- Either not vaccinated or vaccinated against key respiratory pathogens (pertussis, COVID-19, RSV, influenza, pneumococcal) within 12 months before or during run-in, but not during treatment period
- Patients vaccinated with other vaccines that do not affect lower respiratory tract (e.g., hepatitis B, shingles, papilloma virus) may also be included
You will not qualify if you...
- Female patients who are pregnant, lactating, or planning pregnancy during run-in or treatment periods
- Females of child-bearing potential not using effective contraception throughout the study
- Known allergy or contraindication to bacterial lysates or any tablet ingredients
- Pneumonia as defined by EMA Referral Procedure EMEA/H/A-31/1465
- 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 as METAVIR F1-F4
- Malignancies with remission less than 5 years
- Wheezing caused by gastroesophageal reflux
- Legal or mental incapacity preventing informed consent
- Inability or unwillingness to comply with study requirements
- History of autoimmune diseases or acute intestinal infections as specified in Buccalin4 SmPC
- Use of steroids, immunosuppressants, immunostimulants, gamma globulins, or bacterial lysates within specified periods prior to randomization
- Major surgery within 3 months before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 24 months
Participants take BUCCALIN® tablets or placebo for preventing recurrent lower respiratory tract infections.
Visits occur according to protocol during the 24-month treatment period
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
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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