Trial to reduce preschool wheezing episodes

A MAJOR clinical trial aiming to reduce hospital admissions for wheezing preschoolers has reached a significant milestone.

The ARROW (Assessing the Reduction of Recurrent admissions using OM-85 for the treatment of preschool Wheeze) trial is testing a new treatment for childhood wheeze.

It involves 46 hospitals participating in the Children’s Inpatient Research Collaboration of Australia and New Zealand (CIRCAN) and recently recruited its 1,000th child.

Study lead Professor Peter Vuillermin, a paediatrician from the Barwon Health and Deakin University Clinical Trials Alliance, said wheezing illnesses were the leading global cause of hospital admissions among preschool-aged children.

“Wheeze episodes are distressing for children and their families and are a strong predictor of asthma in later life,” he said.

“Over a third of young children admitted to hospital with a wheeze episode will be readmitted within a year with another episode. Unfortunately, we still don’t have a treatment that we know substantially reduces this risk.

“There is strong evidence that children who are exposed to a wider range of environmental bacteria in early life, such as those who grow up on farms with livestock, have lower rates of wheezing illnesses and asthma.”

Part of the trial involves the testing of OM-85. an oral medication that boosts immunity by delivering a dose of inactive (broken-down) bacteria, which is effective in preventing hospital admissions among young children with recurrent, severe wheezing illnesses.

Dr Jessica Costa-Pinto, a paediatrician and PhD scholar, said previous studies had shown OM-85 could reduce respiratory tract infections and may reduce wheeze episodes in children.

“This large clinical trial will tell us if it can also prevent hospital admissions from wheeze,” she said.

Xander Gillin, three, is one of the 1,000 participants who have signed up for far in the ARROW Trial.

Xander has been in hospital with wheeze episodes eight times in the space of 18 months.His mum, Amanda, is hopeful the trial will identify effective treatment to reduce these episodes.

The trial is a randomised, double-blind, placebo-controlled trial that aims to eventually recruit 1,088 children aged between one and six with a history of recurrent wheeze requiring hospital admission.

Participants receive either OM-85 or a placebo for the first 10 days of each month over 12 months.

Families complete weekly electronic diaries to track respiratory symptoms and healthcare presentations, and information about hospital presentations is collected using medical records.

A specially developed web application allows clinicians from participating CIRCAN hospitals to refer patients to the trial.

Families of children aged between one and six who have a wheeze-related hospital admission in the past 12 months can also self-refer.

Professor Vuillermin said reaching the milestone of 1,000 children reflected the extraordinary commitment of paediatric doctors and nurses, researchers, and the participating families.

“The ARROW Trial has the potential to improve the health of kids with recurrent wheezing illnesses in Australia, New Zealand and around the world. It has been a huge collective effort, and we are very proud of our team and grateful to all who have contributed,” Dr Costa-Pinto said.

Funding for the ARROW Trial has been provided by the National Health and Medical Research Council (NHMRC), Cure Kids, the Starship Foundation, and OM-Pharma.

Clinicians or families interested in becoming involved can email the team at [email protected]