(OM-85 in Prevention of Asthma in Children)

This is a phase 2, single-centre, double blind, randomised, placebo-controlled, study testing the primary prevention of persistent asthma in high risk children by protection against acute respiratory infections during early childhood using OM-85. Persistent asthma is a major problem yet none of the current therapies do more than control the condition. The long-term solution is to prevent asthma from progressing to the persistent form. The purpose of this study is to see if we can prevent asthma by stopping some of the events that happen early in life which may cause asthma. These are events like respiratory tract infections (colds and flu), wheezing and sensitisation to allergens.

OM-85 is an immune-stimulant which primes the immune system so that the body can respond quickly to infections and reduce damage to the lungs to prevent asthma from developing. OM-85 is a capsule and powder from capsule is dissolved in water and given to the child. The child receives OM-85 or placebo as five blocks of 10 days treatment plus 20 days no treatment for two winters and then they are followed up in the third year without any treatment.

This study is funded by the National Health and Medical Research Council and is being conducted at the Lady Cilento Children’s Hospital in Brisbane. Child Health Research Centre at The University of Queensland is the sponsor for the study. The recruitment for this study has been completed and participants are being followed up.

For enquiries about the study please contact the clinical team on clear@uq.edu.au