Assessing the Reduction of Recurrent admissions using OM-85 for the treatment of preschool Wheeze (ARROW): a multi-centre, randomised, double-blind, placebo-controlled trial

Acute wheezing illnesses present a huge health and economic burden and are the most common reason that preschool aged children are admitted to hospital in Australia. Current strategies to prevent hospital admissions due to preschool wheeze are ineffective, and parents and paediatricians identify developing effective treatments to prevent hospital admission as a research priority.

OM-85 is an orally administered bacterial lysate that stimulates immune responses associated with defence against viral infections and reduces the excessive inflammation of the respiratory mucosa associated with wheezing episodes.

Compelling evidence from animal, laboratory and clinical studies supports the hypothesis that OM-85 has the potential to reduce the risk of hospital admission due to preschool wheeze.

Current trials of OM-85 have neither been designed, nor powered, to address this question, which is critical to both consumers and the health system.

We will use the CIRCAN platform to conduct a large, pragmatic, feasible and cost-effective trial addressing a critical knowledge gap. The end-user engagement from inception and detailed cost-effectiveness analysis will facilitate rapid translation of the findings into policy and improved health outcomes in Australasia and internationally.

We have assembled a highly experienced transdisciplinary research team with expertise in all aspects of successful completion of a large-scale clinical trial, end-user engagement and translation of research findings in practice and policy. Funded by NHMRC and leveraging the Children’s Inpatient Research Collaborative of Australia and New Zealand (CIRCAN), our team includes clinicians from 35 hospitals across Australasia. Recruitment will begin in January 2021 and continue for two and a half years. Participants will be followed for 12 months.

The ARROW Trial was registered with the Australian New Zealand Clinical Trials Registry (Registration number: ACTRN12620001370998p).

For further information please contact The ARROW trial team at arrowtrial@deakin.edu.au

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