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 treatmentonly during an upper RTI to prevent WE): ≥2 WEs including at least 1 severeepisode (i.e., treated with OCS OR having triggered an EDvisit/hospitalization), OR ≥3 WEs including at least one that triggered anunscheduled physician visit, in the 12 months prior to enrollment.

• For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR havingtriggered an ED visit/hospitalization) OR ≥2 WEs including at least one thattriggered an unscheduled physician visit, as reported by parents or LAR ofsubject (i.e., guardians), in the 12 months prior to enrollment, while being ontheir daily controller therapy (at current dose or higher).

• Up-to-date vaccination status as per applicable State or country VaccinationRequirements for school/day-care entry.

• Parents or LAR have provided the appropriate written informed consent. Writteninformed consent must be provided before any study-specific procedures are performedincluding 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.

• Wheezing documented to be caused by gastroesophageal reflux.

• Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).

• Any known autoimmune disease.

• Known human immunodeficiency virus (HIV) infection or any known type of congenitalor iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency).

• Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic orrenal function abnormalities.

• Children born prematurely i.e., before 34 weeks of gestational age.

• Children with an abnormally low or high weight for their age and height, if thiswould not allow safe completion of the clinical study in the opinion of theinvestigator.

• Any known neoplasia or malignancy.

• Treatment with the following medications:

• Systemic corticosteroids within 4 weeks before study enrollment.

• Previous and/or concomitant immunosuppressants, immunostimulants, or gammaglobulins within 6 months before study enrollment.

• Any major surgery within the last 3 months prior to study enrollment or plannedduring the study duration.

• Known allergy or previous intolerance to investigational drug.

• Any other clinical conditions, which in the opinion of the Investigator, would notallow safe completion of the clinical study.

• Other household members have previously been randomized in this clinical study andhave not completed their 6-month treatment period.

• Inability to comply with the study requested visit schedule (e.g., expectedrelocation within 12 months of the screening for the study).

• Currently enrolled in or has completed any other investigational device or drugstudy <30 days prior to screening or receiving other investigational agent(s).

Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.