A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

Inclusion Criteria: Subjects who meet all the following criteria will be included in the study: * Children of either gender, aged between 6 and 72 months (5 years inclusive). * Children with recurrent wheezing: * For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including at least one that triggered an unscheduled physician visit, in the 12 months prior to enrollment. * For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR ≥2 WEs including at least one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy (at current dose or higher). * Up-to-date vaccination status as per applicable State or country Vaccination Requirements for school/day-care entry. * Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures. Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week. Exclusion Criteria: * Known anatomic alterations of the respiratory tract. *…