Condition: Respiratory Infection · Lower Respiratory Tract Infection (LRTI) · Sponsor: Laboratorio Farmaceutico SIT srl
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.
This description comes directly from the study's public registry record.
Silvana Lonetti · +39 0384 8071 · s.lonetti@sit-farmaceutici.com
Always discuss trial participation with your own doctor first.
| 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 |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06736288