POWER: Prevention with OM-85 of wheezing exacerbation recurrence trial..

The proposed project aims to show that immunomodulation (IM) using a bacterial lysate can deviate the immune system towards more natural responses and away from those that lead to wheeze and do this by reprogramming key response pathways. We plan to use a state-of-the-art, systems biology methodology to precisely identify the responses involved as the basis of establishing IM as a safe, practical and scientifically-sound therapy. We will recruit “high-risk” wheezing preschool children and give a 12 months course of bacterial lysate with the inclusion of a placebo arm so that we can accurately determine how bacterial lysates perturb these responses. To ensure that the immunological data relate to a clinically relevant change, the study is designed to achieve a parallel clinical outcome. The knowledge this project will obtain is essential to understand how current IM agents deviate the immune system away from responses leading to wheeze and asthma. In turn, this information is essential to allow this field of research to develop to improve health translation by identifying the key regulatory checkpoints that can be targeted for novel asthma therapies as well as the development of more focused and efficient IM preparations with potentially permanent effects.