To participate in this study, your child must:

• Be between 6 months and 5 years of age (inclusive, i.e., until the day before their 6th birthday)
• Have experienced episodes of wheezing over the last 12 months

There are additional criteria that are reviewed by the study team during your first appointment.

You and your child will meet with a study coordinator at a study site location closest to you. You will learn more about the research study and the benefits and risks of participation.

The study coordinator or study doctor will review the Informed Consent Form with you. You will have the chance to ask any questions about this form, and sign once comfortable and willing to participate in the study. Only after you have consented, different information will be collected and physical examination performed to see if your child qualifies for the clinical study.

OM-85, under the brand name of Broncho-Vaxom, is a medicine designed to reduce and prevent inflammation and infection in the lungs, causing wheezing and breathing difficulties. Although it is not currently registered and available in the USA, it has been authorized for the prevention of recurrent respiratory tract infections (RTIs) in various other countries worldwide since 1979.

This study will include a screening visit, at which baseline physical evaluations will be done. A history of other medical background and current medications will be collected, and subjects’ parents or legal representatives will be trained to recognize, manage, and report wheezing episodes during the study. There will then be a 10-20 days screening period during which parents (or legal representatives) will be given the opportunity to familiarize themselves with the study electronic diary app and report any issue they may be facing.

After the screening period, the children will be in a 6-month treatment period in which they will take the OM-85 or placebo capsule once daily. They will be monitored throughout, via both physical and virtual visits. After 6 months of treatment, the child will stop the medicine and have a 6-month period of observation in which their health will be assessed through 2 virtual visits, and a final study center visit. Additional, so-called “unscheduled” virtual or physical visits may be organized throughout the study when children are experiencing wheezing or other relevant respiratory symptoms.

The study centers are located throughout the USA, at approximately 30 locations.

Your child will not have to stop taking their medication unless otherwise advised by the study center staff or their primary care physician.

Prior and concomitant medication will be recorded by the study staff, and you will be asked to report any medication taken by your child to manage symptoms of recurrent wheezing or respiratory tract infection in the study electronic diary.

No, there will be no cost to you for the study therapy or study procedures.

No, health insurance is not a requirement to participate in the study.