Study of PMBL Sublingual Tablets to Reduce Respiratory Infections in Children Aged 3 to 12 Years

What this Trial Is About

Researchers are evaluating the efficacy of PMBL4 sublingual tablets in preventing recurrent respiratory tract infections RTIs in children aged 3 to 12 years. RTIs are common acute illnesses caused mainly by viral pathogens and occur most frequently during the fall and winter seasons. Although PMBL4 is authorized in some European countries for preventing RTIs, existing studies have methodological limitations. This phase IV randomized, double-blind, placebo-controlled trial aims to provide more reliable evidence on PMBL4s effectiveness in this pediatric population. Participants will be randomly assigned to receive either PMBL4 or a placebo, both administered as one sublingual tablet daily before food for ten consecutive days each month over three months during the fall-winter period. The placebo tablet is identical in appearance and usage but lacks active ingredients. After the treatment phase, subjects will be followed for an additional four months to monitor respiratory infections. The study includes a diary for participants to record RTI events promptly, with optional visits if needed for accurate assessment. Throughout the 7-month study period 3 months of treatment plus 4 months of follow-up, participants will be monitored for the total number of RTIs experienced, duration of each infection, days with infections, antibiotic use, physician consultations, and adverse events. The impact on parents workdays lost due to their childs RTIs will also be recorded. Safety and adherence will be closely observed to evaluate PMBL4s role in RTI prevention in children.

Prevention With Ismigen of RTIs in Kids