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Assessing the Reduction of Recurrent Admissions Using OM-85 for the Treatment of Preschool Wheeze (ARROW): Protocol

Jessica C Costa-Pinto1,2,3, Marisa van Arragon4,5, Katherine J Lee6,7

  • 1Deakin University, Geelong, Victoria, Australia.

Journal of Paediatrics and Child Health
|June 15, 2026
PubMed

Insights

This study investigates OM-85, a bacterial lysate, for preventing hospital readmissions in children with preschool wheeze. The ARROW trial assesses its efficacy in reducing recurrent wheezing illnesses and improving health outcomes.

Area of Science:

  • Pediatric Pulmonology
  • Immunology
  • Clinical Trials

Background:

  • Acute wheezing illnesses are a leading cause of hospital admissions in preschool children.
  • High readmission rates necessitate novel preventive strategies.
  • OM-85, a bacterial lysate, shows potential in modulating immune responses and reducing airway inflammation.

Purpose of the Study:

  • To determine the efficacy of OM-85 in preventing hospital readmissions in children with preschool wheeze.
  • To evaluate OM-85's impact on the frequency and duration of wheezing episodes.
  • To assess the cost-effectiveness of using OM-85 for preschool wheeze management.

Main Methods:

  • A decentralized, Phase 3 randomized, double-blind, placebo-controlled trial (ARROW).
  • Recruitment of 870 children aged 1 to <6 years across over 40 hospitals in Australia and New Zealand.
  • Daily administration of 3.5 mg OM-85 or placebo for 10 days each month over 12 months, with remote and in-person follow-up.

Main Results:

  • Primary outcome: hospital admission due to acute wheezing illness during the 12-month treatment period.
  • Secondary outcomes: frequency and duration of wheeze episodes, cost-effectiveness.
  • Trial registered under ACTRN12620001370998.

Conclusions:

  • The ARROW trial will provide crucial data on OM-85's effectiveness in managing preschool wheeze.
  • Findings may lead to new preventive strategies, reducing hospitalizations and healthcare costs.
  • Results will be disseminated through peer-reviewed international journals.
Abstract

Keywords:
OM‐85Paediatricsimmunomodulatorpreschool asthmapreschool wheezerandomised controlled trial

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