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

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 congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency).
• •Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal 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 this would not allow safe completion of the clinical study in the opinion of the investigator.
• •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 gamma globulins within 6 months before study enrollment.
• •Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
• •Known allergy or previous intolerance to investigational drug.
• •Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
• •Other household members have previously been randomized in this clinical study and have not completed their 6-month treatment period.
• •Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
• •Currently enrolled in or has completed any other investigational device or drug study \<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.