A randomized double-blind placebo-controlled study to demonstrate the efficacy of PMBL® sublingual tablets in reducing the incidence of respiratory tract infections in children aged 3-12 years (PIRTIK).

Trial status: Authorised - % of pts free of RTI during the overall study period - Mean duration in days per RTI during the overall study period (OST) – No. of days with RTI during the OST – No. of days of antibiotics use during the OST - Total no. of workdays lost by parents due to their child’s RTI during the OST – No. of physician consultations due to RTI or related complications – No. of antibiotic treatments (courses) for a respiratory event during the OST – No. of pts with (serious) AE and (serious) ADR Rate of Respiratory Tract Infections (RTIs): the number of RTIs experienced by a subject throughout the study (3 month-treatment period and 4 month-follow-up) will be assessed.

- % of pts free of RTI during the overall study period - Mean duration in days per RTI during the overall study period (OST) – No. of days with RTI during the OST – No. of days of antibiotics use during the OST - Total no. of workdays lost by parents due to their child’s RTI during the OST – No. of physician consultations due to RTI or related complications – No. of antibiotic treatments (courses) for a respiratory event during the OST – No. of pts with (serious) AE and (serious) ADR

Age group: 0-17 years Gender: Female, Male Target enrollment: 224 participants