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.
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).
not vaccinated or
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).
Parallel
BUCCALIN®
DrugGastro-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.
Placebo
Other interventionGastro-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.
RLRTIs Episodes: Reduction in the number of infection episodes in the treatment period (12 months) in the Buccalin® group versus the Placebo group.
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