Does Your Child Have Recurrent Wheezing?

The EAGLE study’s main purpose is to evaluate both the safety and efficacy of the investigational medicine (OM-85) in children with recurrent wheezing. This is a randomized, double-blind study, which means nobody involved will know whether participants receive the active study drug (OM-85) or matching placebo. The placebo is a capsule with no active medication in it, and will have no effect on the person taking it. It looks exactly like the investigational medication, so the participant will not know which they are taking.  This will allow the study to verify if the investigational drug does make a difference in symptoms, vs the placebo.

All participants who are eligible and successfully enroll in this study will receive either the investigational medication OM-85 or placebo.  Both the medication and placebo are capsules whose contents can be stirred into a drink and are taken only once daily for the duration of the treatment period (180 days, i.e. about 6 months). 

There will be a screening period of up to 20 days, followed by a 6-month treatment period, and completed with 6 months of an observational, off-treatment period.

Qualified participants will receive all study-related care and study medication at no cost. Participants will be asked to visit the study site 5 times throughout the entire study period. These scheduled visits may include physical exams, blood sampling (before the first dose and at the end of the treatment period), as well as nasal swabs and stool sample collection (before the first dose, and at the end of the treatment period and at the end of the study). 

Scheduled physical visits may be completed by additional virtual or physical visits in case your child experiences wheezing or other relevant respiratory symptoms during the study. You will be asked to complete an electronic study diary when your child experiences respiratory symptoms. This can be done directly on your own device.